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How to Write a Research Paper | A Beginner's Guide

A research paper is a piece of academic writing that provides analysis, interpretation, and argument based on in-depth independent research.

Research papers are similar to academic essays , but they are usually longer and more detailed assignments, designed to assess not only your writing skills but also your skills in scholarly research. Writing a research paper requires you to demonstrate a strong knowledge of your topic, engage with a variety of sources, and make an original contribution to the debate.

This step-by-step guide takes you through the entire writing process, from understanding your assignment to proofreading your final draft.

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Table of contents

Understand the assignment, choose a research paper topic, conduct preliminary research, develop a thesis statement, create a research paper outline, write a first draft of the research paper, write the introduction, write a compelling body of text, write the conclusion, the second draft, the revision process, research paper checklist, free lecture slides.

Completing a research paper successfully means accomplishing the specific tasks set out for you. Before you start, make sure you thoroughly understanding the assignment task sheet:

• Read it carefully, looking for anything confusing you might need to clarify with your professor.
• Identify the assignment goal, deadline, length specifications, formatting, and submission method.
• Make a bulleted list of the key points, then go back and cross completed items off as you’re writing.

Carefully consider your timeframe and word limit: be realistic, and plan enough time to research, write, and edit.

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There are many ways to generate an idea for a research paper, from brainstorming with pen and paper to talking it through with a fellow student or professor.

You can try free writing, which involves taking a broad topic and writing continuously for two or three minutes to identify absolutely anything relevant that could be interesting.

You can also gain inspiration from other research. The discussion or recommendations sections of research papers often include ideas for other specific topics that require further examination.

Once you have a broad subject area, narrow it down to choose a topic that interests you, m eets the criteria of your assignment, and i s possible to research. Aim for ideas that are both original and specific:

• A paper following the chronology of World War II would not be original or specific enough.
• A paper on the experience of Danish citizens living close to the German border during World War II would be specific and could be original enough.

Note any discussions that seem important to the topic, and try to find an issue that you can focus your paper around. Use a variety of sources , including journals, books, and reliable websites, to ensure you do not miss anything glaring.

Do not only verify the ideas you have in mind, but look for sources that contradict your point of view.

• Is there anything people seem to overlook in the sources you research?
• Are there any heated debates you can address?
• Do you have a unique take on your topic?
• Have there been some recent developments that build on the extant research?

In this stage, you might find it helpful to formulate some research questions to help guide you. To write research questions, try to finish the following sentence: “I want to know how/what/why…”

A thesis statement is a statement of your central argument — it establishes the purpose and position of your paper. If you started with a research question, the thesis statement should answer it. It should also show what evidence and reasoning you’ll use to support that answer.

The thesis statement should be concise, contentious, and coherent. That means it should briefly summarize your argument in a sentence or two, make a claim that requires further evidence or analysis, and make a coherent point that relates to every part of the paper.

You will probably revise and refine the thesis statement as you do more research, but it can serve as a guide throughout the writing process. Every paragraph should aim to support and develop this central claim.

A research paper outline is essentially a list of the key topics, arguments, and evidence you want to include, divided into sections with headings so that you know roughly what the paper will look like before you start writing.

A structure outline can help make the writing process much more efficient, so it’s worth dedicating some time to create one.

Your first draft won’t be perfect — you can polish later on. Your priorities at this stage are as follows:

• Maintaining forward momentum — write now, perfect later.
• Paying attention to clear organization and logical ordering of paragraphs and sentences, which will help when you come to the second draft.
• Expressing your ideas as clearly as possible, so you know what you were trying to say when you come back to the text.

You do not need to start by writing the introduction. Begin where it feels most natural for you — some prefer to finish the most difficult sections first, while others choose to start with the easiest part. If you created an outline, use it as a map while you work.

Do not delete large sections of text. If you begin to dislike something you have written or find it doesn’t quite fit, move it to a different document, but don’t lose it completely — you never know if it might come in useful later.

Paragraph structure

Paragraphs are the basic building blocks of research papers. Each one should focus on a single claim or idea that helps to establish the overall argument or purpose of the paper.

Example paragraph

George Orwell’s 1946 essay “Politics and the English Language” has had an enduring impact on thought about the relationship between politics and language. This impact is particularly obvious in light of the various critical review articles that have recently referenced the essay. For example, consider Mark Falcoff’s 2009 article in The National Review Online, “The Perversion of Language; or, Orwell Revisited,” in which he analyzes several common words (“activist,” “civil-rights leader,” “diversity,” and more). Falcoff’s close analysis of the ambiguity built into political language intentionally mirrors Orwell’s own point-by-point analysis of the political language of his day. Even 63 years after its publication, Orwell’s essay is emulated by contemporary thinkers.

Citing sources

It’s also important to keep track of citations at this stage to avoid accidental plagiarism . Each time you use a source, make sure to take note of where the information came from.

You can use our free citation generators to automatically create citations and save your reference list as you go.

APA Citation Generator MLA Citation Generator

The research paper introduction should address three questions: What, why, and how? After finishing the introduction, the reader should know what the paper is about, why it is worth reading, and how you’ll build your arguments.

What? Be specific about the topic of the paper, introduce the background, and define key terms or concepts.

Why? This is the most important, but also the most difficult, part of the introduction. Try to provide brief answers to the following questions: What new material or insight are you offering? What important issues does your essay help define or answer?

How? To let the reader know what to expect from the rest of the paper, the introduction should include a “map” of what will be discussed, briefly presenting the key elements of the paper in chronological order.

The major struggle faced by most writers is how to organize the information presented in the paper, which is one reason an outline is so useful. However, remember that the outline is only a guide and, when writing, you can be flexible with the order in which the information and arguments are presented.

One way to stay on track is to use your thesis statement and topic sentences . Check:

• topic sentences against the thesis statement;
• topic sentences against each other, for similarities and logical ordering;
• and each sentence against the topic sentence of that paragraph.

Be aware of paragraphs that seem to cover the same things. If two paragraphs discuss something similar, they must approach that topic in different ways. Aim to create smooth transitions between sentences, paragraphs, and sections.

The research paper conclusion is designed to help your reader out of the paper’s argument, giving them a sense of finality.

Trace the course of the paper, emphasizing how it all comes together to prove your thesis statement. Give the paper a sense of finality by making sure the reader understands how you’ve settled the issues raised in the introduction.

You might also discuss the more general consequences of the argument, outline what the paper offers to future students of the topic, and suggest any questions the paper’s argument raises but cannot or does not try to answer.

You should not :

• Offer new arguments or essential information
• Take up any more space than necessary
• Begin with stock phrases that signal you are ending the paper (e.g. “In conclusion”)

There are four main considerations when it comes to the second draft.

• Check how your vision of the paper lines up with the first draft and, more importantly, that your paper still answers the assignment.
• Identify any assumptions that might require (more substantial) justification, keeping your reader’s perspective foremost in mind. Remove these points if you cannot substantiate them further.
• Be open to rearranging your ideas. Check whether any sections feel out of place and whether your ideas could be better organized.
• If you find that old ideas do not fit as well as you anticipated, you should cut them out or condense them. You might also find that new and well-suited ideas occurred to you during the writing of the first draft — now is the time to make them part of the paper.

The goal during the revision and proofreading process is to ensure you have completed all the necessary tasks and that the paper is as well-articulated as possible. You can speed up the proofreading process by using the AI proofreader .

Global concerns

• Confirm that your paper completes every task specified in your assignment sheet.
• Check for logical organization and flow of paragraphs.
• Check paragraphs against the introduction and thesis statement.

Fine-grained details

Check the content of each paragraph, making sure that:

• each sentence helps support the topic sentence.
• no unnecessary or irrelevant information is present.
• all technical terms your audience might not know are identified.

Next, think about sentence structure , grammatical errors, and formatting . Check that you have correctly used transition words and phrases to show the connections between your ideas. Look for typos, cut unnecessary words, and check for consistency in aspects such as heading formatting and spellings .

Finally, you need to make sure your paper is correctly formatted according to the rules of the citation style you are using. For example, you might need to include an MLA heading  or create an APA title page .

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Checklist: Research paper

I have followed all instructions in the assignment sheet.

My introduction presents my topic in an engaging way and provides necessary background information.

My introduction presents a clear, focused research problem and/or thesis statement .

My paper is logically organized using paragraphs and (if relevant) section headings .

Each paragraph is clearly focused on one central idea, expressed in a clear topic sentence .

Each paragraph is relevant to my research problem or thesis statement.

I have used appropriate transitions  to clarify the connections between sections, paragraphs, and sentences.

My conclusion provides a concise answer to the research question or emphasizes how the thesis has been supported.

My conclusion shows how my research has contributed to knowledge or understanding of my topic.

My conclusion does not present any new points or information essential to my argument.

I have provided an in-text citation every time I refer to ideas or information from a source.

I have included a reference list at the end of my paper, consistently formatted according to a specific citation style .

I have thoroughly revised my paper and addressed any feedback from my professor or supervisor.

I have followed all formatting guidelines (page numbers, headers, spacing, etc.).

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How to Write and Publish a Research Paper for a Peer-Reviewed Journal

Clara busse.

1 Department of Maternal and Child Health, University of North Carolina Gillings School of Global Public Health, 135 Dauer Dr, 27599 Chapel Hill, NC USA

Ella August

2 Department of Epidemiology, University of Michigan School of Public Health, 1415 Washington Heights, Ann Arbor, MI 48109-2029 USA

Associated Data

Communicating research findings is an essential step in the research process. Often, peer-reviewed journals are the forum for such communication, yet many researchers are never taught how to write a publishable scientific paper. In this article, we explain the basic structure of a scientific paper and describe the information that should be included in each section. We also identify common pitfalls for each section and recommend strategies to avoid them. Further, we give advice about target journal selection and authorship. In the online resource 1 , we provide an example of a high-quality scientific paper, with annotations identifying the elements we describe in this article.

Electronic supplementary material

The online version of this article (10.1007/s13187-020-01751-z) contains supplementary material, which is available to authorized users.

Introduction

Writing a scientific paper is an important component of the research process, yet researchers often receive little formal training in scientific writing. This is especially true in low-resource settings. In this article, we explain why choosing a target journal is important, give advice about authorship, provide a basic structure for writing each section of a scientific paper, and describe common pitfalls and recommendations for each section. In the online resource 1 , we also include an annotated journal article that identifies the key elements and writing approaches that we detail here. Before you begin your research, make sure you have ethical clearance from all relevant ethical review boards.

Select a Target Journal Early in the Writing Process

We recommend that you select a “target journal” early in the writing process; a “target journal” is the journal to which you plan to submit your paper. Each journal has a set of core readers and you should tailor your writing to this readership. For example, if you plan to submit a manuscript about vaping during pregnancy to a pregnancy-focused journal, you will need to explain what vaping is because readers of this journal may not have a background in this topic. However, if you were to submit that same article to a tobacco journal, you would not need to provide as much background information about vaping.

Information about a journal’s core readership can be found on its website, usually in a section called “About this journal” or something similar. For example, the Journal of Cancer Education presents such information on the “Aims and Scope” page of its website, which can be found here: https://www.springer.com/journal/13187/aims-and-scope .

Peer reviewer guidelines from your target journal are an additional resource that can help you tailor your writing to the journal and provide additional advice about crafting an effective article [ 1 ]. These are not always available, but it is worth a quick web search to find out.

Identify Author Roles Early in the Process

Early in the writing process, identify authors, determine the order of authors, and discuss the responsibilities of each author. Standard author responsibilities have been identified by The International Committee of Medical Journal Editors (ICMJE) [ 2 ]. To set clear expectations about each team member’s responsibilities and prevent errors in communication, we also suggest outlining more detailed roles, such as who will draft each section of the manuscript, write the abstract, submit the paper electronically, serve as corresponding author, and write the cover letter. It is best to formalize this agreement in writing after discussing it, circulating the document to the author team for approval. We suggest creating a title page on which all authors are listed in the agreed-upon order. It may be necessary to adjust authorship roles and order during the development of the paper. If a new author order is agreed upon, be sure to update the title page in the manuscript draft.

In the case where multiple papers will result from a single study, authors should discuss who will author each paper. Additionally, authors should agree on a deadline for each paper and the lead author should take responsibility for producing an initial draft by this deadline.

Structure of the Introduction Section

The introduction section should be approximately three to five paragraphs in length. Look at examples from your target journal to decide the appropriate length. This section should include the elements shown in Fig.  1 . Begin with a general context, narrowing to the specific focus of the paper. Include five main elements: why your research is important, what is already known about the topic, the “gap” or what is not yet known about the topic, why it is important to learn the new information that your research adds, and the specific research aim(s) that your paper addresses. Your research aim should address the gap you identified. Be sure to add enough background information to enable readers to understand your study. Table ​ Table1 1 provides common introduction section pitfalls and recommendations for addressing them.

The main elements of the introduction section of an original research article. Often, the elements overlap

Common introduction section pitfalls and recommendations

Methods Section

The purpose of the methods section is twofold: to explain how the study was done in enough detail to enable its replication and to provide enough contextual detail to enable readers to understand and interpret the results. In general, the essential elements of a methods section are the following: a description of the setting and participants, the study design and timing, the recruitment and sampling, the data collection process, the dataset, the dependent and independent variables, the covariates, the analytic approach for each research objective, and the ethical approval. The hallmark of an exemplary methods section is the justification of why each method was used. Table ​ Table2 2 provides common methods section pitfalls and recommendations for addressing them.

Common methods section pitfalls and recommendations

Results Section

The focus of the results section should be associations, or lack thereof, rather than statistical tests. Two considerations should guide your writing here. First, the results should present answers to each part of the research aim. Second, return to the methods section to ensure that the analysis and variables for each result have been explained.

Begin the results section by describing the number of participants in the final sample and details such as the number who were approached to participate, the proportion who were eligible and who enrolled, and the number of participants who dropped out. The next part of the results should describe the participant characteristics. After that, you may organize your results by the aim or by putting the most exciting results first. Do not forget to report your non-significant associations. These are still findings.

Tables and figures capture the reader’s attention and efficiently communicate your main findings [ 3 ]. Each table and figure should have a clear message and should complement, rather than repeat, the text. Tables and figures should communicate all salient details necessary for a reader to understand the findings without consulting the text. Include information on comparisons and tests, as well as information about the sample and timing of the study in the title, legend, or in a footnote. Note that figures are often more visually interesting than tables, so if it is feasible to make a figure, make a figure. To avoid confusing the reader, either avoid abbreviations in tables and figures, or define them in a footnote. Note that there should not be citations in the results section and you should not interpret results here. Table ​ Table3 3 provides common results section pitfalls and recommendations for addressing them.

Common results section pitfalls and recommendations

Discussion Section

Opposite the introduction section, the discussion should take the form of a right-side-up triangle beginning with interpretation of your results and moving to general implications (Fig.  2 ). This section typically begins with a restatement of the main findings, which can usually be accomplished with a few carefully-crafted sentences.

Major elements of the discussion section of an original research article. Often, the elements overlap

Next, interpret the meaning or explain the significance of your results, lifting the reader’s gaze from the study’s specific findings to more general applications. Then, compare these study findings with other research. Are these findings in agreement or disagreement with those from other studies? Does this study impart additional nuance to well-accepted theories? Situate your findings within the broader context of scientific literature, then explain the pathways or mechanisms that might give rise to, or explain, the results.

Journals vary in their approach to strengths and limitations sections: some are embedded paragraphs within the discussion section, while some mandate separate section headings. Keep in mind that every study has strengths and limitations. Candidly reporting yours helps readers to correctly interpret your research findings.

The next element of the discussion is a summary of the potential impacts and applications of the research. Should these results be used to optimally design an intervention? Does the work have implications for clinical protocols or public policy? These considerations will help the reader to further grasp the possible impacts of the presented work.

Finally, the discussion should conclude with specific suggestions for future work. Here, you have an opportunity to illuminate specific gaps in the literature that compel further study. Avoid the phrase “future research is necessary” because the recommendation is too general to be helpful to readers. Instead, provide substantive and specific recommendations for future studies. Table ​ Table4 4 provides common discussion section pitfalls and recommendations for addressing them.

Common discussion section pitfalls and recommendations

Follow the Journal’s Author Guidelines

After you select a target journal, identify the journal’s author guidelines to guide the formatting of your manuscript and references. Author guidelines will often (but not always) include instructions for titles, cover letters, and other components of a manuscript submission. Read the guidelines carefully. If you do not follow the guidelines, your article will be sent back to you.

Finally, do not submit your paper to more than one journal at a time. Even if this is not explicitly stated in the author guidelines of your target journal, it is considered inappropriate and unprofessional.

Your title should invite readers to continue reading beyond the first page [ 4 , 5 ]. It should be informative and interesting. Consider describing the independent and dependent variables, the population and setting, the study design, the timing, and even the main result in your title. Because the focus of the paper can change as you write and revise, we recommend you wait until you have finished writing your paper before composing the title.

Be sure that the title is useful for potential readers searching for your topic. The keywords you select should complement those in your title to maximize the likelihood that a researcher will find your paper through a database search. Avoid using abbreviations in your title unless they are very well known, such as SNP, because it is more likely that someone will use a complete word rather than an abbreviation as a search term to help readers find your paper.

After you have written a complete draft, use the checklist (Fig. ​ (Fig.3) 3 ) below to guide your revisions and editing. Additional resources are available on writing the abstract and citing references [ 5 ]. When you feel that your work is ready, ask a trusted colleague or two to read the work and provide informal feedback. The box below provides a checklist that summarizes the key points offered in this article.

Checklist for manuscript quality

(PDF 362 kb)

Acknowledgments

Ella August is grateful to the Sustainable Sciences Institute for mentoring her in training researchers on writing and publishing their research.

Code Availability

Not applicable.

Data Availability

Compliance with ethical standards.

The authors declare that they have no conflict of interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Journal of Materials Chemistry A

Promoting your work to the materials community: editor top tips for writing an effective research paper.

* Corresponding authors

a Department of Materials Science and Engineering, North Carolina State University, Raleigh, North Carolina 27695-7001, USA E-mail: [email protected]

b School of Chemistry, University College Dublin, Belfield, Ireland E-mail: [email protected]

c Electrochemical Process Engineering (EPE) Division, CSIR-Central Electrochemical Research Institute (CECRI), Karaikudi, Tamil Nadu 630003, India E-mail: [email protected]

d Department of Chemistry, University of California, Davis, California 95616, USA E-mail: [email protected]

e Fachbereich Chemie, Universität Konstanz, Universitätsstraße 10, 78457 Kostanz, Germany E-mail: [email protected]

Authors and editors alike want publications in the Journal of Materials Chemistry A to be visible to the community and to have strong impact in their respective fields and beyond. To help authors craft manuscripts that will be exciting, impactful and meaningful, and to withstand the test of time, the editors of J. Mater. Chem. A provide their tips and recommendations on structuring your paper to emphasise the new insights, rigour, and significance of your work.

Article information

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V. Augustyn, S. A. Cussen, S. Kundu, F. E. Osterloh and M. M. Unterlass, J. Mater. Chem. A , 2024,  12 , 17753 DOI: 10.1039/D4TA90097A

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Journal articles are the academic's stock in trade, t he basic means of communicating research findings to an audience of one’s peers. That holds true across the disciplinary spectrum, so no matter where you land as a concentrator, you can expect to rely on them heavily. 

Regardless of the discipline, moreover,  journal articles perform an important knowledge-updating function .

Textbooks and handbooks and manuals will have a secondary function for chemists and physicists and biologists, of course. But in the sciences, articles are the standard and  preferred publication form. 

In the social sciences and humanities , where knowledge develops a little less rapidly or is driven less by issues of time-sensitivity , journal articles and books are more often used together.

Not all important and influential ideas warrant book-length studies, and some inquiry is just better suited to the size and scope and concentrated discussion that the article format offers.

Journal articles sometimes just present the most  appropriate  solution for communicating findings or making a convincing argument.  A 20-page article may perfectly fit a researcher's needs.  Sustaining that argument for 200 pages might be unnecessary -- or impossible.

The quality of a research article and the legitimacy of its findings are verified by other scholars, prior to publication, through a rigorous evaluation method called peer-review . This seal of approval by other scholars doesn't mean that an article is the best, or truest, or last word on a topic. If that were the case, research on lots of things would cease. Peer review simply means other experts believe the methods, the evidence, the conclusions of an article have met important standards of legitimacy, reliability, and intellectual honesty.

Searching the journal literature is part of being a responsible researcher at any level: professor, grad student, concentrator, first-year. Knowing why academic articles matter will help you make good decisions about what you find -- and what you choose to rely on in your work.

Think of journal articles as the way you tap into the ongoing scholarly conversation , as a way of testing the currency of  a finding, analysis, or argumentative position, and a way of bolstering the authority (or plausibility) of explanations you'll offer in the papers and projects you'll complete at Harvard. 

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In this platform trial with multiple study drugs, participants were able to choose what agents they were willing to be randomized to receive. Participants were first randomized in a ratio of m :1, where m is the number of study drugs for which the participant was eligible. After randomization to receive an active agent vs placebo, participants were randomized with equal probability among the study drugs for which they were eligible. The consort diagram illustrates a sequential exclusion process, where each step of exclusion was applied to ensure that the reasons for participant removal were mutually exclusive. As a result, each participant was excluded for 1 reason even though multiple exclusions may have been present.

Thick vertical lines denote the estimated mean of the posterior distribution. Density is the relative likelihood of posterior probability distribution. Outcomes with higher density are more likely than outcomes with lower density.

Recovery was defined as the third of 3 consecutive days without symptoms. Fifty-nine participants did not provide any follow-up data beyond day 1 and were immediately censored. Fourty-seven participants were censored after some follow-up. All other participantss were followed up until recovery, death, or the end of short-term 28-day follow-up. Median (IQR) time to recovery was 11 (11-12) days in the ivermectin group and 12 (11-12) days in the placebo group. Shaded regions denote the pointwise 95% CIs.

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Data sharing statement

• Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19 JAMA Original Investigation October 25, 2022 This randomized clinical trial compares the efficacy of ivermectin vs placebo in shortening symptom duration among adult outpatients in the US with symptomatic mild to moderate COVID-19. Susanna Naggie, MD, MHS; David R. Boulware, MD, MPH; Christopher J. Lindsell, PhD; Thomas G. Stewart, PhD; Nina Gentile, MD; Sean Collins, MD, MSci; Matthew William McCarthy, MD; Dushyantha Jayaweera, MD; Mario Castro, MD, MPH; Mark Sulkowski, MD; Kathleen McTigue, MD, MPH, MS; Florence Thicklin; G. Michael Felker, MD, MHS; Adit A. Ginde, MD, MPH; Carolyn T. Bramante, MD, MPH; Alex J. Slandzicki, MD; Ahab Gabriel, MD; Nirav S. Shah, MD, MPH; Leslie A. Lenert, MD, MS; Sarah E. Dunsmore, PhD; Stacey J. Adam, PhD; Allison DeLong, BS; George Hanna, MD; April Remaly, BA; Rhonda Wilder, MS; Sybil Wilson, RN; Elizabeth Shenkman, PhD; Adrian F. Hernandez, MD, MHS; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) Study Group and Investigators; William (Kelly) Vincent; Raina  Vincent; Ray  Bianchi; Jen Premas; Diana  Cordero-Loperena; Evelyn Rivera; Madhu  Gupta ; Greg Karawan; Carey  Ziomek; Joseph Arena; Sonaly DeAlmeida; Soroush Ramin; Jaya Nataraj; Michael  Paasche-Orlow; Lori Henault; Katie Waite; David Miller; Ginger Brounce; Constance George-Adebayo; Adeolu Adebayo; Jessica Wallan; Alex Slandzicki; Claudia Vogel; Sebastian Munoz; David Kavtaradze; Cassandra Watson; David Singleton; Maria Rivon; Amanda Sevier; Arnold Del Pilar; Amber Spangler; Sohail Rao; Luis Cantu; Arvind Krishna; Kathy Evans; Tylene  Falkner; Brandi Kerr; Robert Spees; Mailyn Marta; G. Michael Felker; Amanda Harrington; Rowena Dolor; Madison Frazier; Lorraine Vergara; Jessica Wilson; Valencia Burruss; Terri Hurst; Igho Ofotokun; Laurel Bristow; Rajesh Prabhu; Krystal Klicka; Amber Lightfeather; Vicki James; Marcella Rogers; Pradeep Parihar; De'Ambra Torress; Chukwuemeka Oragwu; Ngozi Oguego; Rajesh Pillai; Mustafa Juma; Ahab Gabriel; Emad Ghaly; Dafer Al-Haddadin; Courtney Ramirez; Gammal Hassanien; Samah Ismail; Andrew Meltzer; Seamus Moran; Scott Brehaut; Angelina Roche; Manisha Mehta; Nicole Koppinger; Jose Baez; Ivone Pagan; Dallal Abdelsayed; Mina Aziz; Philip Robinson; Julie Nguyen; Victoria Pardue; Llisa Hammons; Juan Ruiz-Unger; Susan Gonzalez; Lionel Reyes; John Cienki; Gisselle Jimenez; Jonathan Cohen; Matthew Wong; Ying Yuan; Jeremy Szeto; Mark Sulkowski; Lauren Stelmash; Arch Amon; Daniel Haight; Deryl Lamb; Amron Harper; Nancy Pyram-Bernard; Arlen Quintero; Eftim Adhami; Josette Maria; Diksha Paudel; Oksana Raymond; Jeffrey Summers; Tammy  Turner; Leslie Lenert; Sam Gallegos; Elizabeth Ann Szwast; Ahsan Abdulghani; Pravin Vasoya; Conrad Miller; Hawa Wiley; Nirav Shah; Tovah Klein; Julie Castex; Phillip Feliciano; Jacqueline Olivo; Marian Ghaly; Zainub Javed; Alexandra Nawrocki; Anthony Vecchiarelli; Nikki Vigil; Vijaya Cherukuri; Erica Burden; Dawn Linn; Laura Fisher; Vijay Patel; Praksha Patel; Yuti Patel; Leonard Ellison; Jeffrey Harrison; Binod  Shah; Sugata Shah; Upinder Singh; Julia Donahue; Yasmin Jazayeri; Anita Gupta ; N Chandrasekar; Beth Moritz; Tabitha Fortt; Anisa Fortt; Ingrid Jones-Ince; Alix McKee; Christy Schattinger; Jason Wilson; Brenda Farlow; Nina Gentile; Lillian Finlaw; Randall Richwine; Tearani Williams; Penny Paizer; Lisa  Carson; Edward Michelson; Danielle Austin; Sangeeta  Khetpal; Tiffany Cantrell; Drew Franklin; Karissa Marshall; Arvind Mahadevan; Madelyn Rosequist; Martin Gnoni; Crystal Daffner; Carla VandeWeerd; Mitchell Roberts; Mark D'Andrea; Stephen Lim; Wayne  Swink; Margaret Powers-Fletcher; Sylvere Mukunzi; Elizabeth Shenkman; Jamie Hensley; Brittney Manning; Carmen Isache; Jennifer Bowman; Angelique Callaghan-Brown; Taylor Scott; Tiffany Schwasinger-Schmidt; Ashlie Cornejo; Dushyantha Jayaweera; Maria Almanzar; Letty Ginsburg; Americo Hajaz; Carolyn Bramante; Matthew Robinson; Michelle Seithel; Akira Sekikawa; Emily Klawson; Luis Ostrosky; Virginia Umana; Thomas Patterson; Robin Tragus; Patrick  Jackson; Caroline Hallowell; Heather Haughey; Bhavna Vaidya-Tank; Cameron Gould; Parul Goyal; Carly Gatewood; John Williamson; Hannah Seagle; Matthew McCarthy; Elizabeth Salsgiver; Eddie Armas; Jhonsai Cheng; Priscilla Huerta; Julia Garcia-Diaz; David Aamodt; JaMario Ayers; Jess Collins; John Graves; James Grindstaff; Frank Harrell; Jessica Lai; Itzel Lopez; Jessica Marlin; Alyssa Merkel; Sam Nwosu; Savannah Obregon; Dirk Orozco; Yoli Perez-Torres; Nelson Prato; Colleen Ratcliff; Max Rhode; Russell Rothman; Jana Shirey-Rice; Krista Vermillion; Hsi-Nien Tan; Seibert Tregoning; Meghan Vance; Amber Vongsamphanh; Maria Weir; Nicole Zaleski
• Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19 JAMA Original Investigation January 24, 2023 This randomized, placebo-controlled platform trial compares the use of low-dose fluvoxamine (50 mg twice daily) for 10 days compared with placebo in outpatients with mild to moderate COVID-19. Matthew W. McCarthy, MD; Susanna Naggie, MD, MHS; David R. Boulware, MD, MPH; Christopher J. Lindsell, PhD; Thomas G. Stewart, PhD; G. Michael Felker, MD, MHS; Dushyantha Jayaweera, MD; Mark Sulkowski, MD; Nina Gentile, MD; Carolyn Bramante, MD, MPH; Upinder Singh, MD; Rowena J. Dolor, MD, MHS; Juan Ruiz-Unger, MD; Sybil Wilson, RN; Allison DeLong, BS; April Remaly, BA; Rhonda Wilder, MS; Sean Collins, MD, MSci; Sarah E. Dunsmore, PhD; Stacey J. Adam, PhD; Florence Thicklin; George Hanna, MD; Adit A. Ginde, MD, MPH; Mario Castro, MD, MPH; Kathleen McTigue, MD, MPH, MS; Elizabeth Shenkman, PhD; Adrian F. Hernandez, MD, MHS; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators; William (Kelly) Vincent; Raina  Vincent; Ray  Bianchi; Jen Premas; Diana Cordero-Loperena Evelyn Rivera; Madhu  Gupta ; Greg Karawan; Carey  Ziomek; Joseph Arena; Sonaly DeAlmeida; Soroush Ramin; Jaya Nataraj; Michael  Paasche-Orlow; Lori Henault; Katie Waite; David Miller; Ginger Brounce; Constance George-Adebayo; Adeolu Adebayo; Jessica Wallan; Claudia Vogel; Sebastian Munoz; David Kavtaradze; Cassandra Watson; David Singleton; Maria Rivon; Amanda Sevier; Arnold Del Pilar; Amber Spangler; Sohail Rao; Luis Cantu; Arvind Krishna; Kathy Evans; Tylene  Falkner; Brandi Kerr; Robert Spees; Mailyn Marta; Amanda Harrington; Madison Frazier; Lorraine Vergara; Jessica Wilson; Valencia Burruss; Terri Hurst; Igho Ofotokun; Laurel Bristow; Rajesh Prabhu; Krystal Klicka; Amber Lightfeather; Vicki James; Marcella Rogers; Pradeep Parihar; De'Ambra Torress; Chukwuemeka Oragwu; Ngozi Oguego; Rajesh Pillai; Mustafa Juma; Emad Ghaly; Dafer Al-Haddadin; Courtney Ramirez; Gammal Hassanien; Samah Ismail; Andrew Meltzer; Seamus Moran; Scott Brehaut; Angelina Roche; Manisha Mehta; Nicole Koppinger; Jose Baez; Ivone Pagan; Dallal Abdelsayed; Mina Aziz; Philip Robinson; Julie Nguyen; Victoria Pardue; Llisa Hammons; Susan Gonzalez; Lionel Reyes; John Cienki; Gisselle Jimenez; Jonathan Cohen; Matthew Wong; Ying Yuan; Jeremy Szeto; Lauren Stelmash; Arch Amon; Daniel Haight; Deryl Lamb; Amron Harper; Nancy Pyram-Bernard; Arlen Quintero; Eftim Adhami; Josette Maria; Diksha Paudel; Oksana Raymond; Jeffrey Summers; Tammy  Turner; Sam Gallegos; Elizabeth Ann Szwast; Ahsan Abdulghani; Pravin Vasoya; Conrad Miller; Hawa Wiley; Tovah Klein; Julie Castex; Phillip Feliciano; Jacqueline Olivo; Marian Ghaly; Zainub Javed; Alexandra Nawrocki; Anthony Vecchiarelli; Nikki Vigil; Vijaya Cherukuri; Erica Burden; Dawn Linn; Laura Fisher; Vijay Patel; Praksha Patel; Yuti Patel; Leonard Ellison; Jeffrey Harrison; Binod  Shah; Sugata Shah; Upinder Shah; Julia Donahue; Yasmin Jazayeri; Anita Gupta ; N Chandrasekar; Beth Moritz; Tabitha Fortt; Anisa Fortt; Ingrid Jones-Ince; Alix McKee; Christy Schattinger; Jason Wilson; Brenda Farlow; Lillian Finlaw; Randall Richwine; Tearani Williams; Penny Paizer; Lisa  Carson; Edward Michelson; Danielle Austin; Sangeeta  Khetpal; Tiffany Cantrell; Drew Franklin; Karissa Marshall; Arvind Mahadevan; Madelyn Rosequist; Martin Gnoni; Crystal Daffner; Carla VandeWeerd; Mitchell Roberts; Mark D'Andrea; Stephen Lim; Wayne  Swink; Margaret Powers-Fletcher; Sylvere Mukunzi; Jamie Hensley; Brittney Manning; Carmen Isache; Jennifer Bowman; Angelique Callaghan-Brown; Taylor Scott; Tiffany Schwasinger-Schmidt; Ashlie Cornejo; Maria Almanzar; Letty Ginsburg; Americo Hajaz; Matthew Robinson; Michelle Seithel; Akira Sekikawa; Emily Klawson; Luis Ostrosky; Virginia Umana; Thomas Patterson; Robin Tragus; Patrick  Jackson; Caroline Hallowell; Heather Haughey; Bhavna Vaidya-Tank; Cameron Gould; Parul Goyal; Carly Gatewood; John Williamson; Hannah Seagle; Elizabeth Salsgiver; Eddie Armas; Jhonsai Cheng; Priscilla Huerta; Julia Garcia-Diaz; David Aamodt; JaMario Ayers; Jess Collins; John Graves; James Grindstaff; Jessica Lai; Itzel Lopez; Jessica Marlin; Alyssa Merkel; Sam Nwosu; Savannah Obregon; Dirk Orozco; Yoli Perez-Torres; Nelson Prato; Colleen Ratcliff; Max Rhode; Russell Rothman; Jana Shirey-Rice; Krista Vermillion; Hsi-Nien Tan; Seibert Tregoning; Meghan Vance; Amber Vongsamphanh; Maria Weir; Nicole Zaleski
• Managing Persistent Uncertainty in the Ethics of Clinical Research JAMA Editorial March 21, 2023 Alex John London, PhD; Christopher W. Seymour, MD, MSc
• Highlights from CROI, the Conference on Retroviruses and Opportunistic Infections JAMA Medical News & Perspectives March 28, 2023 This Medical News Q&A discusses research highlights from the recent Conference on Retroviruses and Opportunistic Infections. Rita Rubin, MA
• Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19 JAMA Original Investigation December 26, 2023 This randomized study examines the effect of higher-dose fluvoxamine on time to sustained recovery from mild to moderate COVID-19 or progression to severe disease in nonhospitalized adults. Thomas G. Stewart, PhD; Paulina A. Rebolledo, MD, MSc; Ahmad Mourad, MD; Christopher J. Lindsell, PhD; David R. Boulware, MD, MPH; Matthew W. McCarthy, MD; Florence Thicklin; Idania T. Garcia del Sol, MD; Carolyn T. Bramante, MD, MPH; Leslie A. Lenert, MD, MS; Stephen Lim, MD; John C. Williamson, PharmD; Orlando Quintero Cardona, MD; Jake Scott, MD; Tiffany Schwasinger-Schmidt, MD, PhD; Adit A. Ginde, MD, MPH; Mario Castro, MD, MPH; Dushyantha Jayaweera, MD; Mark Sulkowski, MD; Nina Gentile, MD; Kathleen McTigue, MD; G. Michael Felker, MD, MHS; Allison DeLong, BS; Rhonda Wilder, MS; Russell L. Rothman, MD, MPP; Sean Collins, MD, MSci; Sarah E. Dunsmore, PhD; Stacey J. Adam, PhD; George J. Hanna, MD; Elizabeth Shenkman, PhD; Adrian F. Hernandez, MD, MHS; Susanna Naggie, MD, MHS; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators; Ryan Fraser; Mark Ward; Jennifer Gamboa Jackman; M. Patricia McAdams; Julia Vail; Kayla Korzekwinski; Martina Oyelakin; Julie Chopp; Desmon Randle; Samantha Dockery; Rodney Adkins; Mathew Crow; Erin Nowell; Kadie Wells; Alicia Herbert; Allegra Stone; Heather Heavlin; Linley Brown; Tina Harding; Amanda Harrington; Meaghan Beauchaine; Kelly Lindblom; Andrea Burns; David Aamodt; Jess Collins; Sheri Dixon; Yue Gao; John Graves; James Grindstaff; Frank Harrell; Jessica Lai; Vicky Liao; Itzel Lopez; Elizabeth Manis; Kalley Mankowski; Jessica Marlin; Alyssa Merkel; Sam Nwosu; Savannah Obregon; Dirk Orozco; Nelson Prato; Max Rohde; Jana Shirey-Rice; Krista Vermillion; Jacob Smith; Hsi-nien Tan; Meghan Vance; Maria Weir; William (Kelly) Vincent; Raina Vincent; Ray Bianchi; Jen Premas; Diana Cordero-Loperena; Evelyn Rivera; Madhu Gupta; Greg Karawan; Joseph Arena; Sonaly DeAlmeida; Soroush Ramin; Jaya Nataraj; Julien Dedier; Ana Maria Ramirez; Katherine Waite; Jason Okulicz; Joseph Marcus; Alexis Southwell; Genice Jacques; Cedar Sexton; David Miller; Ginger Brounce; Constance George-Adebayo; Adeolu Adebayo; Jose Zapatero; Julie Clement; Theresa Ronan; Ashley Woods; Christopher Gallegos; Tamara Flys; Olivia Sloan; Anthony Olofintuyi; Joshua Samraj; Jackelyn Samraj; Alma Vasbinder; Amaya Averett; Alex Slandzicki; Aaron Milstone; Jessica Wallan; Lindsey Robbs; Claudia Vogel; Sebastian Munoz; David Kavtaradze; Casandra Watson; David Singleton; Marcus Sevier; Maria Rivon; Arnold Del Pilar; Amber Spangler; Sohail Rao; Luis Cantu; Arvind Krishna; Heidi Daugherty; Brandi Kerr; Kathy Evans; Robert Spees; Mailyn Marta; Rowena Dolor; Lorraine Vergara; Jackie Jordan; Valencia Burruss; Terri Hurst; Igho Ofotokun; Paulina A. Rebolledo; Cecilia Zhang; Veronica E. Smith; Rajesh Prabhu; Krystal Klicka; Amber Lightfeather; Vickie James; Marcella Rogers; Pradeep Parihar; De'Ambra Torress; Chukwuemeka Oragwu; Ngozi Oguego; Rajesh Pillai; Mustafa Juma; Ahab Gabriel; Emad Ghaly; Marian Michal; Michelle Vasquez; Angela Mamon; Michelle Sheets; Gammal Hassanien; Samah Ismail; Yehia Samir; Andrew Meltzer; Soroush Shahamatdar; Ryan S. Heidish; Scott Brehaut; Angelina Roche; Manisha Mehta; Nicole Koppinger; Jose Baez; Ivone Pagan; Dallal Abdelsayed; Mina Aziz; Philip Robinson; Grace Lozinski; Julie Nguyen; Alvin Griffin; Michael Morris; Nicole Love; Bonnie Mattox; Raykel Martin; Victoria Pardue; Teddy Rowland; Juan Ruiz-Unger; Lionel Reyes; Yadira Zamora; Navila Bacallao; John Cienki; Jonathan Cohen; Ying Yuan; Jenny Li; Jeremy Szeto; Mark Sulkowski; Lauren Stelmash; Idania Garcia del Sol; Ledular Morales Castillo; Anya Gutierrez; Sabrina Prieto; Arch Amon; Andrew Barbera; Andrew Bugajski; Walter Wills; Kellcee Jacklin; Deryl Lamb; Amron Harper; Elmer Stout; Katherine Weeks; Merischia Griffin; Nancy Pyram-Bernard; Arlen Quintero; Eftim Adhami; Giovanni Carrillo; Josette Maria; Diksha Paudel; Oksana Raymond; Jeffrey Summers; Tammy Turner; Ebony Panaccione; Elizabeth Szwast; Ahsan Abdulghani; Pravin Vasoya; Conrad Miller; Hawa Wiley; Austin Chan; Saadia Khizer; Nirav Shah; Oluwadamilola Adeyemi; Wei Ning Chi; July Chen; Melissa Morton-Jost; Julie Castex; Phillip Feliciano; Jacqueline Olivo; Maria Maldonado; Anthony Vecchiarelli; Diana Gaytan-Alvarez; Vijaya Cherukuri; Santia Lima; Radica Alicic; Allison A. Lambert; Carissa Urbat; Joni Baxter; Ann Cooper; Dawn Linn; Laura Fisher; Vijay Patel; Yuti Patel; Roshan Talati; Priti Patel; Leonard Ellison; Angee Roman; Jeffrey Harrison; James Moy; Dina Naquiallah; Binod Shah; Upinder Singh; Yasmin Jazayeri; Andrew O’Donnell; Orlando Quintero; Divya Pathak; Anita Gupta; N Chandrasekar; Clifford Curtis; Briana White; Martha Dockery; Maya Hicks; Tabitha Fortt; Anisa Fortt; Ingrid Jones-Ince; Alix McKee; Jason Wilson; Brenda Farlow; Nina Gentile; Casey Grady; Randall Richwine; Tearani Williams; Penny Pazier; Edward Michelson; Susan Watts; Diluma Kariyawasam; Leann Rodriguez; Jose Luis Garcia; Ismarys Manresa; Angel Achong; Mari Garcia; Sangeeta Khetpal; Faith Posey; Arvind Mahadevan; Martin Gnoni; Carla VandeWeerd; Erica Sappington; Mitchell Roberts; Jennifer Wang; Melissa Adams; Xinyi Ding; Mark D'Andrea; Stephen Lim; Wayne Swink; Emily Bozant; Margaret Powers-Fletcher; Delia Miller; Sylvere Mukunzi; Brittney Manning; Carmen Isache; Jennifer Bowman; Angelique Callaghan-Brown; Debra Martin; Ashley Ast; Brent Duran; Ashlie Cornejo; Allie Archer; Dushyantha Jayaweera; Maria Almanzar; Vanessa Motel; Neeta Bhat; Daniela Parra; Matthew Pullen; Paula Campora; Matthew Robinson; Michelle Seithel; Akira Sekikawa; Emily Klawson; Jonathan Arnold; Luis Ostrosky-Zeichner; Virginia Umana; Laura Nielsen; Carolyn Z. Grimes; Thomas F. Patterson; Robin Tragus; Bridgette T. Soileau; Patrick E.H. Jackson; Carolina Hallowell; Heather M. Haughey; Bhavna Vaidya-Tank; Cameron Gould; Parul Goyal; Sue Sommers; Haley Pangburn; Carly Jones; John Williamson; Rica Abbott; Hannah Seagle; Mathias DeComarmond; Nicholas Pickell; Unwana Umana; Candace Alleyne; Eddie Armas; Ramon O. Perez Landabur; Michelle De La Cruz; Martha Ballmajo
• Error in the Exclusion of Participants From Analysis in the ACTIV-6 Platform Randomized Clinical Trial JAMA Comment & Response June 4, 2024 Susanna Naggie, MD, MHS
• Errors in Results From Erroneous Exclusion of Participants in Analysis JAMA Correction June 4, 2024
• At a Higher Dose and Longer Duration, Ivermectin Still Not Effective Against COVID-19 JAMA Editor's Note March 21, 2023 Kirsten Bibbins-Domingo, PhD, MD, MAS; Preeti N. Malani, MD, MSJ

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Naggie S , Boulware DR , Lindsell CJ, et al. Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19 : A Randomized Clinical Trial . JAMA. 2023;329(11):888–897. doi:10.1001/jama.2023.1650

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Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19 : A Randomized Clinical Trial

• 1 Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
• 2 Department of Medicine, Duke University School of Medicine, Durham, North Carolina
• 3 Division of Infectious Diseases and International Medicine, University of Minnesota, Minneapolis
• 4 Vanderbilt University Medical Center, Nashville, Tennessee
• 5 School of Data Science, University of Virginia, Charlottesville
• 6 Clinical Trials Center of Middle Tennessee, Franklin
• 7 University Medical Center New Orleans, Louisiana State University Health Sciences Center, New Orleans
• 8 Jadestone Clinical Research, LLC, Silver Spring, Maryland
• 9 David Kavtaradze, Inc, Cordele, Georgia
• 10 Lakeland Regional Medical Center, Lakeland, Florida
• 11 Focus Clinical Research Solutions, Charlotte, North Carolina
• 12 Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania
• 13 Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida
• 14 Weill Cornell Medicine, New York, New York
• 15 Division of Infectious Diseases, Johns Hopkins University, Baltimore, Maryland
• 16 Veterans Affairs Tennessee Valley Healthcare System, Geriatric Research, Education and Clinical Center (GRECC), Nashville
• 17 National Center for Advancing Translational Sciences, Bethesda, Maryland
• 18 Foundation for the National Institutes of Health, Bethesda, Maryland
• 19 Stakeholder Advisory Committee, Pittsburgh, Pennsylvania
• 20 Biomedical Advanced Research and Development Authority, Washington, DC
• 21 University of Colorado School of Medicine, Aurora
• 22 Division of Pulmonary, Critical Care and Sleep Medicine, University of Missouri-Kansas City School of Medicine, Kansas City
• 23 Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
• 24 Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville
• Editorial Managing Persistent Uncertainty in the Ethics of Clinical Research Alex John London, PhD; Christopher W. Seymour, MD, MSc JAMA
• Editor's Note At a Higher Dose and Longer Duration, Ivermectin Still Not Effective Against COVID-19 Kirsten Bibbins-Domingo, PhD, MD, MAS; Preeti N. Malani, MD, MSJ JAMA
• Original Investigation Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19 Susanna Naggie, MD, MHS; David R. Boulware, MD, MPH; Christopher J. Lindsell, PhD; Thomas G. Stewart, PhD; Nina Gentile, MD; Sean Collins, MD, MSci; Matthew William McCarthy, MD; Dushyantha Jayaweera, MD; Mario Castro, MD, MPH; Mark Sulkowski, MD; Kathleen McTigue, MD, MPH, MS; Florence Thicklin; G. Michael Felker, MD, MHS; Adit A. Ginde, MD, MPH; Carolyn T. Bramante, MD, MPH; Alex J. Slandzicki, MD; Ahab Gabriel, MD; Nirav S. Shah, MD, MPH; Leslie A. Lenert, MD, MS; Sarah E. Dunsmore, PhD; Stacey J. Adam, PhD; Allison DeLong, BS; George Hanna, MD; April Remaly, BA; Rhonda Wilder, MS; Sybil Wilson, RN; Elizabeth Shenkman, PhD; Adrian F. Hernandez, MD, MHS; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) Study Group and Investigators; William (Kelly) Vincent; Raina  Vincent; Ray  Bianchi; Jen Premas; Diana  Cordero-Loperena; Evelyn Rivera; Madhu  Gupta ; Greg Karawan; Carey  Ziomek; Joseph Arena; Sonaly DeAlmeida; Soroush Ramin; Jaya Nataraj; Michael  Paasche-Orlow; Lori Henault; Katie Waite; David Miller; Ginger Brounce; Constance George-Adebayo; Adeolu Adebayo; Jessica Wallan; Alex Slandzicki; Claudia Vogel; Sebastian Munoz; David Kavtaradze; Cassandra Watson; David Singleton; Maria Rivon; Amanda Sevier; Arnold Del Pilar; Amber Spangler; Sohail Rao; Luis Cantu; Arvind Krishna; Kathy Evans; Tylene  Falkner; Brandi Kerr; Robert Spees; Mailyn Marta; G. Michael Felker; Amanda Harrington; Rowena Dolor; Madison Frazier; Lorraine Vergara; Jessica Wilson; Valencia Burruss; Terri Hurst; Igho Ofotokun; Laurel Bristow; Rajesh Prabhu; Krystal Klicka; Amber Lightfeather; Vicki James; Marcella Rogers; Pradeep Parihar; De'Ambra Torress; Chukwuemeka Oragwu; Ngozi Oguego; Rajesh Pillai; Mustafa Juma; Ahab Gabriel; Emad Ghaly; Dafer Al-Haddadin; Courtney Ramirez; Gammal Hassanien; Samah Ismail; Andrew Meltzer; Seamus Moran; Scott Brehaut; Angelina Roche; Manisha Mehta; Nicole Koppinger; Jose Baez; Ivone Pagan; Dallal Abdelsayed; Mina Aziz; Philip Robinson; Julie Nguyen; Victoria Pardue; Llisa Hammons; Juan Ruiz-Unger; Susan Gonzalez; Lionel Reyes; John Cienki; Gisselle Jimenez; Jonathan Cohen; Matthew Wong; Ying Yuan; Jeremy Szeto; Mark Sulkowski; Lauren Stelmash; Arch Amon; Daniel Haight; Deryl Lamb; Amron Harper; Nancy Pyram-Bernard; Arlen Quintero; Eftim Adhami; Josette Maria; Diksha Paudel; Oksana Raymond; Jeffrey Summers; Tammy  Turner; Leslie Lenert; Sam Gallegos; Elizabeth Ann Szwast; Ahsan Abdulghani; Pravin Vasoya; Conrad Miller; Hawa Wiley; Nirav Shah; Tovah Klein; Julie Castex; Phillip Feliciano; Jacqueline Olivo; Marian Ghaly; Zainub Javed; Alexandra Nawrocki; Anthony Vecchiarelli; Nikki Vigil; Vijaya Cherukuri; Erica Burden; Dawn Linn; Laura Fisher; Vijay Patel; Praksha Patel; Yuti Patel; Leonard Ellison; Jeffrey Harrison; Binod  Shah; Sugata Shah; Upinder Singh; Julia Donahue; Yasmin Jazayeri; Anita Gupta ; N Chandrasekar; Beth Moritz; Tabitha Fortt; Anisa Fortt; Ingrid Jones-Ince; Alix McKee; Christy Schattinger; Jason Wilson; Brenda Farlow; Nina Gentile; Lillian Finlaw; Randall Richwine; Tearani Williams; Penny Paizer; Lisa  Carson; Edward Michelson; Danielle Austin; Sangeeta  Khetpal; Tiffany Cantrell; Drew Franklin; Karissa Marshall; Arvind Mahadevan; Madelyn Rosequist; Martin Gnoni; Crystal Daffner; Carla VandeWeerd; Mitchell Roberts; Mark D'Andrea; Stephen Lim; Wayne  Swink; Margaret Powers-Fletcher; Sylvere Mukunzi; Elizabeth Shenkman; Jamie Hensley; Brittney Manning; Carmen Isache; Jennifer Bowman; Angelique Callaghan-Brown; Taylor Scott; Tiffany Schwasinger-Schmidt; Ashlie Cornejo; Dushyantha Jayaweera; Maria Almanzar; Letty Ginsburg; Americo Hajaz; Carolyn Bramante; Matthew Robinson; Michelle Seithel; Akira Sekikawa; Emily Klawson; Luis Ostrosky; Virginia Umana; Thomas Patterson; Robin Tragus; Patrick  Jackson; Caroline Hallowell; Heather Haughey; Bhavna Vaidya-Tank; Cameron Gould; Parul Goyal; Carly Gatewood; John Williamson; Hannah Seagle; Matthew McCarthy; Elizabeth Salsgiver; Eddie Armas; Jhonsai Cheng; Priscilla Huerta; Julia Garcia-Diaz; David Aamodt; JaMario Ayers; Jess Collins; John Graves; James Grindstaff; Frank Harrell; Jessica Lai; Itzel Lopez; Jessica Marlin; Alyssa Merkel; Sam Nwosu; Savannah Obregon; Dirk Orozco; Yoli Perez-Torres; Nelson Prato; Colleen Ratcliff; Max Rhode; Russell Rothman; Jana Shirey-Rice; Krista Vermillion; Hsi-Nien Tan; Seibert Tregoning; Meghan Vance; Amber Vongsamphanh; Maria Weir; Nicole Zaleski JAMA
• Original Investigation Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19 Matthew W. McCarthy, MD; Susanna Naggie, MD, MHS; David R. Boulware, MD, MPH; Christopher J. Lindsell, PhD; Thomas G. Stewart, PhD; G. Michael Felker, MD, MHS; Dushyantha Jayaweera, MD; Mark Sulkowski, MD; Nina Gentile, MD; Carolyn Bramante, MD, MPH; Upinder Singh, MD; Rowena J. Dolor, MD, MHS; Juan Ruiz-Unger, MD; Sybil Wilson, RN; Allison DeLong, BS; April Remaly, BA; Rhonda Wilder, MS; Sean Collins, MD, MSci; Sarah E. Dunsmore, PhD; Stacey J. Adam, PhD; Florence Thicklin; George Hanna, MD; Adit A. Ginde, MD, MPH; Mario Castro, MD, MPH; Kathleen McTigue, MD, MPH, MS; Elizabeth Shenkman, PhD; Adrian F. Hernandez, MD, MHS; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators; William (Kelly) Vincent; Raina  Vincent; Ray  Bianchi; Jen Premas; Diana Cordero-Loperena Evelyn Rivera; Madhu  Gupta ; Greg Karawan; Carey  Ziomek; Joseph Arena; Sonaly DeAlmeida; Soroush Ramin; Jaya Nataraj; Michael  Paasche-Orlow; Lori Henault; Katie Waite; David Miller; Ginger Brounce; Constance George-Adebayo; Adeolu Adebayo; Jessica Wallan; Claudia Vogel; Sebastian Munoz; David Kavtaradze; Cassandra Watson; David Singleton; Maria Rivon; Amanda Sevier; Arnold Del Pilar; Amber Spangler; Sohail Rao; Luis Cantu; Arvind Krishna; Kathy Evans; Tylene  Falkner; Brandi Kerr; Robert Spees; Mailyn Marta; Amanda Harrington; Madison Frazier; Lorraine Vergara; Jessica Wilson; Valencia Burruss; Terri Hurst; Igho Ofotokun; Laurel Bristow; Rajesh Prabhu; Krystal Klicka; Amber Lightfeather; Vicki James; Marcella Rogers; Pradeep Parihar; De'Ambra Torress; Chukwuemeka Oragwu; Ngozi Oguego; Rajesh Pillai; Mustafa Juma; Emad Ghaly; Dafer Al-Haddadin; Courtney Ramirez; Gammal Hassanien; Samah Ismail; Andrew Meltzer; Seamus Moran; Scott Brehaut; Angelina Roche; Manisha Mehta; Nicole Koppinger; Jose Baez; Ivone Pagan; Dallal Abdelsayed; Mina Aziz; Philip Robinson; Julie Nguyen; Victoria Pardue; Llisa Hammons; Susan Gonzalez; Lionel Reyes; John Cienki; Gisselle Jimenez; Jonathan Cohen; Matthew Wong; Ying Yuan; Jeremy Szeto; Lauren Stelmash; Arch Amon; Daniel Haight; Deryl Lamb; Amron Harper; Nancy Pyram-Bernard; Arlen Quintero; Eftim Adhami; Josette Maria; Diksha Paudel; Oksana Raymond; Jeffrey Summers; Tammy  Turner; Sam Gallegos; Elizabeth Ann Szwast; Ahsan Abdulghani; Pravin Vasoya; Conrad Miller; Hawa Wiley; Tovah Klein; Julie Castex; Phillip Feliciano; Jacqueline Olivo; Marian Ghaly; Zainub Javed; Alexandra Nawrocki; Anthony Vecchiarelli; Nikki Vigil; Vijaya Cherukuri; Erica Burden; Dawn Linn; Laura Fisher; Vijay Patel; Praksha Patel; Yuti Patel; Leonard Ellison; Jeffrey Harrison; Binod  Shah; Sugata Shah; Upinder Shah; Julia Donahue; Yasmin Jazayeri; Anita Gupta ; N Chandrasekar; Beth Moritz; Tabitha Fortt; Anisa Fortt; Ingrid Jones-Ince; Alix McKee; Christy Schattinger; Jason Wilson; Brenda Farlow; Lillian Finlaw; Randall Richwine; Tearani Williams; Penny Paizer; Lisa  Carson; Edward Michelson; Danielle Austin; Sangeeta  Khetpal; Tiffany Cantrell; Drew Franklin; Karissa Marshall; Arvind Mahadevan; Madelyn Rosequist; Martin Gnoni; Crystal Daffner; Carla VandeWeerd; Mitchell Roberts; Mark D'Andrea; Stephen Lim; Wayne  Swink; Margaret Powers-Fletcher; Sylvere Mukunzi; Jamie Hensley; Brittney Manning; Carmen Isache; Jennifer Bowman; Angelique Callaghan-Brown; Taylor Scott; Tiffany Schwasinger-Schmidt; Ashlie Cornejo; Maria Almanzar; Letty Ginsburg; Americo Hajaz; Matthew Robinson; Michelle Seithel; Akira Sekikawa; Emily Klawson; Luis Ostrosky; Virginia Umana; Thomas Patterson; Robin Tragus; Patrick  Jackson; Caroline Hallowell; Heather Haughey; Bhavna Vaidya-Tank; Cameron Gould; Parul Goyal; Carly Gatewood; John Williamson; Hannah Seagle; Elizabeth Salsgiver; Eddie Armas; Jhonsai Cheng; Priscilla Huerta; Julia Garcia-Diaz; David Aamodt; JaMario Ayers; Jess Collins; John Graves; James Grindstaff; Jessica Lai; Itzel Lopez; Jessica Marlin; Alyssa Merkel; Sam Nwosu; Savannah Obregon; Dirk Orozco; Yoli Perez-Torres; Nelson Prato; Colleen Ratcliff; Max Rhode; Russell Rothman; Jana Shirey-Rice; Krista Vermillion; Hsi-Nien Tan; Seibert Tregoning; Meghan Vance; Amber Vongsamphanh; Maria Weir; Nicole Zaleski JAMA
• Medical News & Perspectives Highlights from CROI, the Conference on Retroviruses and Opportunistic Infections Rita Rubin, MA JAMA
• Original Investigation Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19 Thomas G. Stewart, PhD; Paulina A. Rebolledo, MD, MSc; Ahmad Mourad, MD; Christopher J. Lindsell, PhD; David R. Boulware, MD, MPH; Matthew W. McCarthy, MD; Florence Thicklin; Idania T. Garcia del Sol, MD; Carolyn T. Bramante, MD, MPH; Leslie A. Lenert, MD, MS; Stephen Lim, MD; John C. Williamson, PharmD; Orlando Quintero Cardona, MD; Jake Scott, MD; Tiffany Schwasinger-Schmidt, MD, PhD; Adit A. Ginde, MD, MPH; Mario Castro, MD, MPH; Dushyantha Jayaweera, MD; Mark Sulkowski, MD; Nina Gentile, MD; Kathleen McTigue, MD; G. Michael Felker, MD, MHS; Allison DeLong, BS; Rhonda Wilder, MS; Russell L. Rothman, MD, MPP; Sean Collins, MD, MSci; Sarah E. Dunsmore, PhD; Stacey J. Adam, PhD; George J. Hanna, MD; Elizabeth Shenkman, PhD; Adrian F. Hernandez, MD, MHS; Susanna Naggie, MD, MHS; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators; Ryan Fraser; Mark Ward; Jennifer Gamboa Jackman; M. Patricia McAdams; Julia Vail; Kayla Korzekwinski; Martina Oyelakin; Julie Chopp; Desmon Randle; Samantha Dockery; Rodney Adkins; Mathew Crow; Erin Nowell; Kadie Wells; Alicia Herbert; Allegra Stone; Heather Heavlin; Linley Brown; Tina Harding; Amanda Harrington; Meaghan Beauchaine; Kelly Lindblom; Andrea Burns; David Aamodt; Jess Collins; Sheri Dixon; Yue Gao; John Graves; James Grindstaff; Frank Harrell; Jessica Lai; Vicky Liao; Itzel Lopez; Elizabeth Manis; Kalley Mankowski; Jessica Marlin; Alyssa Merkel; Sam Nwosu; Savannah Obregon; Dirk Orozco; Nelson Prato; Max Rohde; Jana Shirey-Rice; Krista Vermillion; Jacob Smith; Hsi-nien Tan; Meghan Vance; Maria Weir; William (Kelly) Vincent; Raina Vincent; Ray Bianchi; Jen Premas; Diana Cordero-Loperena; Evelyn Rivera; Madhu Gupta; Greg Karawan; Joseph Arena; Sonaly DeAlmeida; Soroush Ramin; Jaya Nataraj; Julien Dedier; Ana Maria Ramirez; Katherine Waite; Jason Okulicz; Joseph Marcus; Alexis Southwell; Genice Jacques; Cedar Sexton; David Miller; Ginger Brounce; Constance George-Adebayo; Adeolu Adebayo; Jose Zapatero; Julie Clement; Theresa Ronan; Ashley Woods; Christopher Gallegos; Tamara Flys; Olivia Sloan; Anthony Olofintuyi; Joshua Samraj; Jackelyn Samraj; Alma Vasbinder; Amaya Averett; Alex Slandzicki; Aaron Milstone; Jessica Wallan; Lindsey Robbs; Claudia Vogel; Sebastian Munoz; David Kavtaradze; Casandra Watson; David Singleton; Marcus Sevier; Maria Rivon; Arnold Del Pilar; Amber Spangler; Sohail Rao; Luis Cantu; Arvind Krishna; Heidi Daugherty; Brandi Kerr; Kathy Evans; Robert Spees; Mailyn Marta; Rowena Dolor; Lorraine Vergara; Jackie Jordan; Valencia Burruss; Terri Hurst; Igho Ofotokun; Paulina A. Rebolledo; Cecilia Zhang; Veronica E. Smith; Rajesh Prabhu; Krystal Klicka; Amber Lightfeather; Vickie James; Marcella Rogers; Pradeep Parihar; De'Ambra Torress; Chukwuemeka Oragwu; Ngozi Oguego; Rajesh Pillai; Mustafa Juma; Ahab Gabriel; Emad Ghaly; Marian Michal; Michelle Vasquez; Angela Mamon; Michelle Sheets; Gammal Hassanien; Samah Ismail; Yehia Samir; Andrew Meltzer; Soroush Shahamatdar; Ryan S. Heidish; Scott Brehaut; Angelina Roche; Manisha Mehta; Nicole Koppinger; Jose Baez; Ivone Pagan; Dallal Abdelsayed; Mina Aziz; Philip Robinson; Grace Lozinski; Julie Nguyen; Alvin Griffin; Michael Morris; Nicole Love; Bonnie Mattox; Raykel Martin; Victoria Pardue; Teddy Rowland; Juan Ruiz-Unger; Lionel Reyes; Yadira Zamora; Navila Bacallao; John Cienki; Jonathan Cohen; Ying Yuan; Jenny Li; Jeremy Szeto; Mark Sulkowski; Lauren Stelmash; Idania Garcia del Sol; Ledular Morales Castillo; Anya Gutierrez; Sabrina Prieto; Arch Amon; Andrew Barbera; Andrew Bugajski; Walter Wills; Kellcee Jacklin; Deryl Lamb; Amron Harper; Elmer Stout; Katherine Weeks; Merischia Griffin; Nancy Pyram-Bernard; Arlen Quintero; Eftim Adhami; Giovanni Carrillo; Josette Maria; Diksha Paudel; Oksana Raymond; Jeffrey Summers; Tammy Turner; Ebony Panaccione; Elizabeth Szwast; Ahsan Abdulghani; Pravin Vasoya; Conrad Miller; Hawa Wiley; Austin Chan; Saadia Khizer; Nirav Shah; Oluwadamilola Adeyemi; Wei Ning Chi; July Chen; Melissa Morton-Jost; Julie Castex; Phillip Feliciano; Jacqueline Olivo; Maria Maldonado; Anthony Vecchiarelli; Diana Gaytan-Alvarez; Vijaya Cherukuri; Santia Lima; Radica Alicic; Allison A. Lambert; Carissa Urbat; Joni Baxter; Ann Cooper; Dawn Linn; Laura Fisher; Vijay Patel; Yuti Patel; Roshan Talati; Priti Patel; Leonard Ellison; Angee Roman; Jeffrey Harrison; James Moy; Dina Naquiallah; Binod Shah; Upinder Singh; Yasmin Jazayeri; Andrew O’Donnell; Orlando Quintero; Divya Pathak; Anita Gupta; N Chandrasekar; Clifford Curtis; Briana White; Martha Dockery; Maya Hicks; Tabitha Fortt; Anisa Fortt; Ingrid Jones-Ince; Alix McKee; Jason Wilson; Brenda Farlow; Nina Gentile; Casey Grady; Randall Richwine; Tearani Williams; Penny Pazier; Edward Michelson; Susan Watts; Diluma Kariyawasam; Leann Rodriguez; Jose Luis Garcia; Ismarys Manresa; Angel Achong; Mari Garcia; Sangeeta Khetpal; Faith Posey; Arvind Mahadevan; Martin Gnoni; Carla VandeWeerd; Erica Sappington; Mitchell Roberts; Jennifer Wang; Melissa Adams; Xinyi Ding; Mark D'Andrea; Stephen Lim; Wayne Swink; Emily Bozant; Margaret Powers-Fletcher; Delia Miller; Sylvere Mukunzi; Brittney Manning; Carmen Isache; Jennifer Bowman; Angelique Callaghan-Brown; Debra Martin; Ashley Ast; Brent Duran; Ashlie Cornejo; Allie Archer; Dushyantha Jayaweera; Maria Almanzar; Vanessa Motel; Neeta Bhat; Daniela Parra; Matthew Pullen; Paula Campora; Matthew Robinson; Michelle Seithel; Akira Sekikawa; Emily Klawson; Jonathan Arnold; Luis Ostrosky-Zeichner; Virginia Umana; Laura Nielsen; Carolyn Z. Grimes; Thomas F. Patterson; Robin Tragus; Bridgette T. Soileau; Patrick E.H. Jackson; Carolina Hallowell; Heather M. Haughey; Bhavna Vaidya-Tank; Cameron Gould; Parul Goyal; Sue Sommers; Haley Pangburn; Carly Jones; John Williamson; Rica Abbott; Hannah Seagle; Mathias DeComarmond; Nicholas Pickell; Unwana Umana; Candace Alleyne; Eddie Armas; Ramon O. Perez Landabur; Michelle De La Cruz; Martha Ballmajo JAMA
• Comment & Response Error in the Exclusion of Participants From Analysis in the ACTIV-6 Platform Randomized Clinical Trial Susanna Naggie, MD, MHS JAMA
• Correction Errors in Results From Erroneous Exclusion of Participants in Analysis JAMA

Question   Does ivermectin, with a maximum targeted dose of 600 μg/kg daily for 6 days, compared with placebo, shorten symptom duration among adult (≥30 years) outpatients with symptomatic mild to moderate COVID-19?

Findings   In this double-blind, randomized, placebo-controlled platform trial including 1432 US adults with COVID-19 during February 2022 to July 2022, the median time to sustained recovery was 11 days in the ivermectin group and 12 days in the placebo group. In this largely vaccinated (83%) population, the posterior probability that ivermectin reduced symptom duration by more than 1 day was less than 0.1%.

Meaning   These findings do not support the use of ivermectin among outpatients with COVID-19.

Importance   It is unknown whether ivermectin, with a maximum targeted dose of 600 μg/kg, shortens symptom duration or prevents hospitalization among outpatients with mild to moderate COVID-19.

Objective   To evaluate the effectiveness of ivermectin at a maximum targeted dose of 600 μg/kg daily for 6 days, compared with placebo, for the treatment of early mild to moderate COVID-19.

Design, Setting, and Participants   The ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines 6 (ACTIV-6) platform randomized clinical trial was designed to evaluate repurposed therapies among outpatients with mild to moderate COVID-19. A total of 1432 participants older than 30 years with confirmed COVID-19 experiencing at least 2 symptoms of acute infection for less than or equal to 7 days were enrolled at 93 sites in the US from February 16, 2022, through July 22, 2022, with follow-up data through November 10, 2022.

Interventions   Participants were randomly assigned to receive ivermectin, with a maximum targeted dose of 600 μg/kg (n = 708) daily, or placebo (n = 724) for 6 days.

Main Outcomes and Measures   The primary outcome was time to sustained recovery, defined as at least 3 consecutive days without symptoms. The 7 secondary outcomes included a composite of hospitalization, death, or urgent/emergent care utilization by day 28.

Results   Among 1432 randomized participants who received study medication or placebo, the median (IQR) age was 48 (38-58) years, 854 (59.6%) were women, and 1188 (83.1%) reported receiving at least 2 SARS-CoV-2 vaccine doses. The median (IQR) time to sustained recovery was 11 (11-12) days in the ivermectin group and 12 (11-12) days in the placebo group. The hazard ratio for improvement in time to recovery was 1.02 (95% credible interval, 0.92-1.12; P  value for efficacy = .65). Among those receiving ivermectin, 39 (5.5%) were hospitalized, died, or had urgent or emergency care visits compared with 42 (5.8%) receiving placebo (hazard ratio, 0.97 [95% credible interval, 0.60-1.45]; P  = .55). In the ivermectin group, 1 participant died and 6 were hospitalized (1.0%); 2 participants (0.3%) were hospitalized in the placebo group and there were no deaths. Adverse events were uncommon in both groups.

Conclusions and Relevance   Among outpatients with mild to moderate COVID-19, treatment with ivermectin, with a maximum targeted dose of 600 μg/kg daily for 6 days, compared with placebo did not improve time to sustained recovery. These findings do not support the use of ivermectin in patients with mild to moderate COVID-19.

Trial Registration   ClinicalTrials.gov Identifier: NCT04885530

Despite treatment advances for COVID-19, the evolution of SARS-CoV-2 variants and subvariants has shifted therapeutic options, including the recent loss of effectiveness of monoclonal antibodies. Novel oral antivirals have been authorized for high-risk individuals in high-income countries. 1 , 2 However, efficacy of these antivirals in those vaccinated or with prior SARS-CoV-2 infection remains unclear. Interest remains for the potential of repurposed drugs to improve symptoms and clinical outcomes among patients with COVID-19.

Numerous repurposed drugs have been investigated for COVID-19 management, with several large randomized outpatient trials published. 3 - 5 Trial results have been mixed. Trials of some drugs suggest possible benefit by reducing emergency department (ED) visits or hospitalizations, including fluvoxamine dosed at 100 mg twice daily 3 and immediate-release metformin. 6 Others have failed to show a reduction in ED visits or hospitalizations, such as fluvoxamine 50 mg twice daily. 6 , 7 Although recently completed trials benefit from the increasing representation of vaccinated people, which is more relevant to the pandemic’s current state, the results have not affected treatment guidelines largely due to study design limitations, including definitions of outcomes that were of unclear significance in the US health care setting. 8 - 10

Ivermectin, an antiparasitic drug used worldwide for onchocerciasis and strongyloidiasis, emerged in 2020 as a potential repurposed drug for COVID-19 initially informed by an in vitro study suggesting possible antiviral activity. 11 The interest for ivermectin as a therapy for COVID-19 has remained high and, although there have been numerous ivermectin studies, its use has become controversial due to a lack of high-quality adequately powered randomized trials and article retractions of some of the earlier and most positive studies. 12 - 15 Three large randomized outpatient trials of people with symptomatic mild or moderate COVID-19 failed to identify a clinical benefit of ivermectin when dosed at 400 μg/kg daily for 3 days. 16 - 18 One possibility is that the dose and duration studied were too low and too short, missing the therapeutic window for ivermectin. A combination of modeling studies and a proof-of-concept clinical study have suggested doses up to 600 μg/kg daily may achieve system levels sufficient for in vitro antiviral activity. 18 , 19 For this reason we tested ivermectin, with a maximum targeted dose of 600 μg/kg daily, for 6 days from February 16, 2022, through July 22, 2022. This report describes the effectiveness of this dose and duration of ivermectin compared with placebo for the treatment of early mild to moderate COVID-19. The primary outcome was time to sustained recovery, defined as at least 3 consecutive days without symptoms, and secondary outcomes included a composite of hospitalization, death, or urgent/emergent care utilization by day 28.

Accelerating COVID-19 Therapeutic Interventions and Vaccines 6 (ACTIV-6) is an ongoing, fully remote (decentralized), double-blind, randomized placebo-controlled platform trial investigating repurposed drugs for the treatment of mild to moderate COVID-19 in the outpatient setting. The platform protocol is designed to be flexible, allowing enrollment across a wide range of settings within health care systems and the community, as well as virtually. The platform enrolls outpatients with mild to moderate COVID-19 with a confirmed positive SARS-CoV-2 test result. The full trial protocol and statistical analysis plan are available in Supplement 1 and Supplement 2 .

The trial protocol was approved by each site’s institutional review board. Participants provided informed consent either via written consent or an electronic consent process. An independent data monitoring committee oversaw participant safety and trial conduct.

Recruitment into the platform trial opened on June 11, 2021, and ivermectin 600 μg/kg was included on the platform beginning on February 16, 2022. Enrollment into the ivermectin 600 μg/kg group was stopped on July 22, 2022, when 1432 participants had received their study drug, identical matched placebo, or contributing placebo. Participants were either identified by sites or self-identified by contacting a central study telephone hotline or website.

Study staff verified eligibility criteria including age of 30 years or older, SARS-CoV-2 infection within 10 days (positive polymerase chain reaction or antigen test result, including home-based tests), and experiencing at least 2 symptoms of acute COVID-19 for no more than 7 days from enrollment. The protocol defined “mild to moderate” as having symptoms as noted above self-reported at the time of enrollment, and symptoms were graded by participants as none, mild, moderate, or severe. Symptoms included fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, and new loss of sense of taste or smell. Exclusion criteria included hospitalization, ivermectin use within 14 days, and known allergy or contraindication to the study drug ( Supplement 1 ). Vaccination against SARS-CoV-2 was allowable, as was concurrent use of standard therapies for COVID-19 available under US Food and Drug Administration Emergency Use Authorization or approval.

Participants were randomized using a random number generator in a 2-step process ( Figure 1 ). First, participants were randomized to receive an active agent or placebo in a ratio of m :1, where m is the number of study drugs for which the participant was eligible; the other study drug under investigation during this period was fluvoxamine 50 mg twice daily for 10 days. Participants could choose to opt out of specific study drug groups during the consent process if they or the site investigator did not feel there was equipoise or if there was a contraindication to any study drug on the platform. After randomization to receive an active agent vs placebo, participants were randomized with equal probability among the study drugs for which they were eligible. The more study drugs a participant was eligible for, the greater the chance of receiving an active agent. Participants who were eligible to receive both ivermectin and fluvoxamine 50 mg but were randomized to the fluvoxamine-matched placebo group were included in and contributed to the placebo group for ivermectin.

A central pharmacy supplied ivermectin or placebo to participants via direct home delivery. Ivermectin was supplied as a bottle of 7-mg tablets. Participants were instructed to take a prespecified number of tablets for 6 consecutive days based on their weight for a maximum targeted daily dose of approximately 600 μg/kg. The dosing schedule was based on weight ranges as follows: those weighing 35 to 52 kg received a 21-mg daily dose; 53 to 69 kg, 28-mg daily dose; 70 to 89 kg, 42-mg daily dose; 90 to 109 kg, 49-mg daily dose; 110 to 129 kg, 56-mg daily dose; and more than 129 kg, 70-mg daily dose. This schedule resulted in a range of doses from 400 to 600 μg/kg (eFigure 1 in Supplement 3 ) and a median (IQR) dose of 498 (464-532) μg/kg per day. The median daily dose was calculated among participants randomized to receive ivermectin. Packaging for the matched placebo was identical to ivermectin and packaging for the contributing placebos was identical to that of the associated study drug, which in this case was fluvoxamine 50 mg twice daily.

The primary measure of effectiveness was time to sustained recovery, defined as the number of days between study drug receipt and the third of 3 consecutive days without symptoms. This outcome was selected a priori from among the 2 co–primary end points that remain available to other study drugs in the platform ( Supplement 2 ). The key secondary outcome was the composite of hospitalization or death by day 28. Other secondary outcomes included mean time unwell, estimated from a longitudinal ordinal model; COVID-19 Clinical Progression Scale score on days 7, 14, and 28; mortality through day 28; and the composite of urgent or emergency care visits, hospitalizations, or death through day 28. The final secondary outcome, the Patient-Reported Outcomes Measurement Information System 29 profile, was to be assessed through day 90 and is not reported in this article because of the longer follow-up.

The study was designed as a fully remote, or decentralized, trial. Screening and eligibility confirmation were participant-reported and site-confirmed. A positive SARS-CoV-2 polymerase chain reaction or antigen test result was verified prior to randomization via uploading into the participant portal and reviewal by the site. At screening, participant-reported demographic information was collected and included race and ethnicity, eligibility criteria, medical history, concomitant medications, symptom reporting, and quality-of-life questionnaires.

A central investigational pharmacy distributed the study drug (either active or placebo) using a next-day priority shipping service. Delivery was tracked and participants needed to have received the study drug within 7 days of enrollment to be included. Confirmation that the study drug was delivered to the participant’s address was required for the participant to be included in the analysis. Receipt of study drug was defined as study day 1.

Participants were asked to complete daily assessments and report adverse events through day 14. Assessments included symptoms and severity, health care visits, and medications. If symptoms were still ongoing at day 14, daily surveys continued until participants experienced 3 consecutive days without symptoms or until day 28. At days 28 and 90, all participants completed assessments. Supplement 1 presents survey details. Additional details of participant monitoring during follow-up are available in Supplement 3 .

This platform trial was designed to be analyzed accepting the possibility of adding and dropping groups as the trial progressed. The general analytical approach was regression modeling. Proportional hazard regression was used for time-to-event analyses and cumulative probability ordinal regression models were used for ordinal outcomes. In addition, the mean time spent unwell was estimated using a longitudinal ordinal regression model as a quantification of benefit.

The complete statistical analysis plan is provided in Supplement 2 . Briefly, the planned primary end point analysis was a bayesian proportional hazards model for time to sustained recovery. The primary inferential (decision-making) quantity was the posterior distribution for the treatment assignment hazard ratio (HR), with HR greater than 1 indicating faster recovery. Decision thresholds and modeling parameters are as previously described 16 and provided in Supplement 2 . The study design was estimated to have 80% power to detect an HR of 1.2 in the primary end point with approximately 1200 participants. To achieve this sample size in an ongoing platform trial, once 1200 participants had been randomized to the study group or matching placebo and had received the study drug, the study group became unavailable for new participants expressing interest in the platform. Some participants had already consented to participate but had not yet been randomized or received the study drug at the time of group closure, and these participants were allowed to continue as assigned.

The primary end point–adjusted model included the following predictor variables in addition to randomization assignment: age (as restricted cubic spline), sex, duration of symptoms at study drug receipt, calendar time (as restricted cubic spline, surrogate for SARS-CoV-2 variant/subvariant), vaccination status (no vaccination vs ≥1 dose), geographic region (Northeast, Midwest, South, West), call center indicator, and day 1 symptom severity. This adjusted model was prespecified. The proportional hazards assumption of the primary end point was evaluated by generating visual diagnostics, such as the log-log plot and plots of time-dependent regression coefficients for each predictor in the model, a diagnostic that indicates deviations from proportionality if the time-dependent coefficients are not constant in time.

Secondary end points were analyzed with bayesian regression models (either proportional hazards or proportional odds) using noninformative priors for all parameters. Secondary end points were not used for formal decision-making, and no decision threshold was selected. Due to an increased potential for type I error due to multiple comparisons, secondary end points should be interpreted as exploratory. The same covariates used in the primary end point model were used in the adjusted analysis of secondary end points, provided that the end point accrued enough events to be analyzed with covariate adjustment.

As a platform trial, the primary analysis is implemented separately for each study drug, where the placebo group consists of contemporaneously randomized participants who met the eligibility criteria for that study drug; this includes both matched and contributing placebo. For this trial, the modified intention-to-treat analysis set for the primary analyses included all participants who received the study drug, and participants were analyzed as assigned. All available data were used to compare ivermectin vs placebo, regardless of postrandomization study drug treatment adherence. In both the primary and secondary end point analyses, missing data among covariates used for adjustment were addressed with conditional mean imputation because the amount of missing covariate data was minimal (<4%).

A prespecified analysis tested for differential treatment effects as a function of preexisting participant characteristics. Analysis of heterogeneity of treatment effect included age, symptom duration, body mass index (BMI), symptom severity on day 1, calendar time (surrogate for SARS-CoV-2 variant), sex, and vaccination status; continuous variables were modeled as such without creating subgroups.

Analyses were performed with R, version 4.1 (R Foundation for Statistical Computing) with primary packages of rstanarm, rmsb, and survival. 20 Additional details are available in Supplement 3 .

Of the 2213 participants who consented for inclusion in the ivermectin group, 1619 were eligible to receive ivermectin and randomized, of whom 1459 were randomized in the ivermectin platform (718 to receive ivermectin and 741 to receive placebo). In the placebo group, 678 were randomized to receive matching placebo and 63 were randomized to receive a shared placebo from another group on the platform. Ultimately, 708 in the ivermectin group and 724 in the placebo group received their medication by mail within 7 days and were included in the modified intention-to-treat cohort for analysis ( Figure 1 ).

Those randomized to receive the active agent in the ivermectin group received the active study drug with a targeted maximum dose of 600 μg/kg; the median (IQR) dose of ivermectin was 498 (464-532) μg/kg (eFigure 1 in Supplement 3 ).

The median (IQR) age of the participants was 48 (38-58) years and 653 (45.6%) were 50 years or older ( Table 1 ). The population included 854 (59.6%) women and 115 participants (8.0%) identified as Black or African American, 102 (7.1%) identified as Asian, and 306 (21.4%) reported being of Latino/Hispanic ethnicity. Although not required for enrollment, high-risk comorbidities included BMI greater than 30 (38.5%), diabetes (9.7%), hypertension (26.7%), asthma (14.6%), and chronic obstructive pulmonary disease (2.4%). Overall, 1188 participants (83.1%) reported receiving at least 2 COVID-19 vaccine doses. Median (IQR) time from symptom onset to enrollment was 3 (2-5) days and to study drug receipt was 5 (3-7) days, with 60% receiving the study drug within 5 days of symptom onset (eFigure 2 in Supplement 3 ). eTable 1 in Supplement 3 presents baseline symptom prevalence and severity.

The median (IQR) time to recovery was 11 (11-12) days in the ivermectin group and 12 (11-12) days in the placebo group. The posterior probability for benefit was .65 for the primary outcome of time to recovery, with an HR of 1.02 (95% credible interval [CrI], 0.92-1.12), where HR greater than 1 indicates faster symptom resolution with ivermectin ( Table 2 and Figure 2 A). This posterior probability was below the prespecified threshold of .95 ( Supplement 2 ). The data do not provide evidence of a conclusive treatment benefit when using a bayesian noninformative prior, no prior, with various approaches to imputing missing symptom data, or when restricting the analysis to participants who received the drug within 2 or 3 days of symptom onset and across severity of symptoms reported on day 1 ( Table 2 , Figure 3 , and eFigures 3 and 4 in Supplement 3 ). The probability that ivermectin reduced symptom duration by 24 hours was less than 0.1%.

Hospitalizations and deaths were uncommon, with 7 events (including 1 death not attributable to COVID-19 or treatment) in the ivermectin group and 2 events (no deaths) in the placebo group (eFigure 5A in Supplement 3 ). Statistical comparisons were uninformative due to the few events. The composite secondary outcome of urgent care or ED visits, hospitalizations, or death was not shown to differ with ivermectin compared with placebo (5.5% [39/708] vs 5.8% [42/722]; HR, 0.97 [95% CrI, 0.60-1.45]; P value for efficacy = .55) ( Table 2 , Figure 2 B, and eFigure 5B in Supplement 3 ). The difference in the amount of time spent feeling unwell with COVID-19 was estimated as 1 hour faster with ivermectin (95% CrI, 9 hours better to 8 hours worse) than placebo ( Figure 2 C). The COVID Clinical Progression Scale scores at days 7, 14, and 28 did not meet prespecified thresholds for beneficial treatment effect ( Supplement 3 ). For example, by day 7, a total of 582 of 677 participants (86%) in the ivermectin group and 600 of 693 (87%) in the placebo group were not hospitalized and did not report limitation of activities (eFigure 6 in Supplement 3 ).

Interaction tests for heterogeneity of treatment effect showed no overall influence of the putative treatment effect modifiers, even when all subgroup analyses across symptom severity were not adjusted for multiple comparisons (eFigure 7 in Supplement 3 ). The overall effect of timing from symptom onset to receipt of the study drug was not significant ( P  = .19 for heterogeneity). Similarly, no evidence existed for a different treatment effect of ivermectin compared with placebo for severity of symptoms, sex, age, BMI, calendar time, or vaccination status (eFigure 8 in Supplement 3 ).

Among participants who reported taking the study drug at least once, adverse events were similar in both groups (53/635 [8.3%] in the ivermectin group and 41/652 [6.3%] in the placebo group with adverse events) (eTable 2 in Supplement 3 ). Adverse events reported more than twice, only in the ivermectin group, included cognitive impairment (n = 6), blurred vision (n = 6), light sensitivity to eye (n = 5), photophobia (n = 4), and dizziness (n = 5). Serious adverse events were rare, with 6 in the ivermectin group and 4 in the placebo group. The death in the ivermectin group was reported to be an accident and not attributable to the study drug or COVID-19.

Among a largely vaccinated outpatient population with mild to moderate COVID-19, treatment with ivermectin, with a targeted maximum dose of 600 μg/kg daily for 6 days, compared with placebo was not shown to improve time to recovery in more than 1200 participants in the US during a period of Omicron variant/subvariant circulation. No evidence of benefit was observed for secondary clinical outcomes, including the composite of hospitalization, death, or acute care visits. Hospitalization and death were uncommon in this largely vaccinated population. These findings do not support the use of ivermectin in outpatients with COVID-19.

Multiple large double-blind randomized clinical trials have failed to identify a clinically meaningful benefit of ivermectin when used at a targeted dose of 400 μg/kg daily for 3 days. 6 , 17 This large clinical trial addresses a potential gap in knowledge by testing (1) a higher daily dose (targeted maximum dose of 600 μg/kg) and (2) a longer (6-day) duration of ivermectin. Due to the lack of early-phase studies or animal-model studies to determine optimal dosing for a therapeutic drug, the appropriate dosing of ivermectin for COVID-19 was never determined. Modeling studies and a proof-of-concept clinical study have suggested that doses up to 600 μg/kg daily may achieve levels sufficient for in vitro antiviral activity 18 , 19 ; however, a phase 2 trial testing ivermectin, 600 μg/kg daily for 7 days, and assessing a virologic end point of oropharyngeal SARS-CoV-2 polymerase chain reaction test result did not show measurable antiviral activity and was stopped for futility. 21 With weight-based dosing, there is additional variability in the range for dosing and, in this study, the dosing per weight strata was targeted to a maximum dose of 600 μg/kg; thus, the median dose across the study population of approximately 500 μg/kg is meaningfully higher than that achieved in studies that targeted a maximum dose of 400 μg/kg. For example, a previous study from the current platform trial that had a maximum targeted dose of ivermectin 400 μg/kg achieved a median dose of 343 μg/kg. The 600-μg/kg dose was safe and generally well tolerated, with a higher prevalence of the known self-resolving visual disturbances in the intervention group previously reported with similar doses of ivermectin for parasitic infections. 18 , 19

The notable difference in baseline characteristics between these 2 cohorts is the completed vaccination rate, which was 83% for this study and 47% for the prior ivermectin 400 μg/kg group. 16 Hospitalizations and COVID-19–related clinical events were less common in this largely vaccinated cohort. The incidence of acute care visits, hospitalizations, or death was similar with ivermectin (5.5%) and placebo (5.8%), which was a result also observed in the 2 previous randomized trials of ivermectin 400 μg/kg in the US. 6 , 16

This trial has several strengths. This was a double-blind, randomized, placebo-controlled nationwide trial with 93 enrolling sites and a call center that recruited participants from all 50 US states. The ivermectin 600 μg/kg group of the platform trial enrolled rapidly due to ongoing Omicron variant/subvariant surges and largely included vaccinated people, thus representing a highly relevant study population that also addresses a weakness of many other studies that excluded vaccinated people. Furthermore, standard-of-care therapies were allowable in this study, although utilization was low.

This study has limitations. Due to infrequent hospitalization, this study cannot assess the effect of the intervention on this clinical outcome. Also, due to the remote nature of the trial, 60% of participants received the study drug within 5 days of symptom onset. Most outpatient COVID-19 antiviral trials have limited enrollment to participants within 5 days of symptom onset. 1 , 2 In this trial, no evidence of a differential treatment effect was observed based on shorter time to study drug receipt. Lastly, the primary end point–adjusted model did not include underlying comorbidities. Treatment effect was putatively expected to differ based on age and BMI, and these were included as covariates and evaluated for heterogeneity of treatment effect.

Among outpatients with mild or moderate COVID-19, treatment with ivermectin, with a targeted maximum dose of 600 μg/kg daily for 6 days, was not shown to improve time to sustained recovery compared with placebo. These findings do not support the use of ivermectin in outpatients with COVID-19.

Corresponding Author: Susanna Naggie, MD, MHS, Duke Clinical Research Institute, Duke University School of Medicine, 300 W Morgan St, Ste 800, Durham, NC 27701 ( [email protected] ).

Accepted for Publication: February 1, 2023.

Published Online: February 20, 2023. doi:10.1001/jama.2023.1650

Correction: This article was corrected on May 16, 2024, because participants were erroneously excluded from the anaysis.

Author Contributions: Drs Lindsell and Stewart had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Naggie, Boulware, Lindsell, Stewart, Kavtaradze, Gentile, Felker, McCarthy, Rothman, Wilson, Remaly, Collins, Thicklin, Ginde, Castro, Hernandez.

Acquisition, analysis, or interpretation of data: Naggie, Boulware, Lindsell, Stewart, Slandzicki, Lim, Cohen, Kavtaradze, Amon, Gabriel, Felker, Jayaweera, Sulkowski, Rothman, DeLong, Wilder, Dunsmore, Adam, Thicklin, Hanna, Castro, McTigue, Shenkman, Hernandez.

Drafting of the manuscript: Naggie, Boulware, Lindsell, Stewart, Amon, McCarthy, Thicklin.

Critical revision of the manuscript for important intellectual content: Boulware, Lindsell, Stewart, Slandzicki, Lim, Cohen, Kavtaradze, Gabriel, Gentile, Felker, Jayaweera, Sulkowski, Rothman, Wilson, DeLong, Remaly, Wilder, Collins, Dunsmore, Adam, Hanna, Ginde, Castro, McTigue, Shenkman, Hernandez.

Statistical analysis: Lindsell, Stewart, McCarthy.

Obtained funding: Naggie, Lindsell, Gabriel, Jayaweera, Collins, Hernandez.

Administrative, technical, or material support: Naggie, Lindsell, Slandzicki, Lim, Cohen, Amon, Gabriel, Jayaweera, Wilson, DeLong, Remaly, Wilder, Dunsmore, Adam, Hanna, McTigue, Hernandez.

Supervision: Naggie, Lindsell, Kavtaradze, Amon, Gabriel, Gentile, Felker, Jayaweera, Rothman, Collins, Castro, Hernandez.

Conflict of Interest Disclosures: Dr Naggie reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study and receiving grants from Gilead Sciences and AbbVie; receiving personal fees from Pardes Biosciences and Silverback Therapeutics for consulting; serving as a scientific advisor for and having stock options in Vir Biotechnology; receiving personal fees from and serving on a data and safety monitoring board for Personal Health Insights; and serving on an event adjudication committee for Bristol Myers Squibb/PRA Health Sciences outside the submitted work. Dr Boulware reported receiving grants from the NIH (#U24TR001608) as co-chair of the ACTIV-6 trial steering committee during the conduct of the study. Dr Lindsell reported receiving grants to the institution from the National Center for Advancing Translational Sciences (NCATS) to the institution during the conduct of the study and grants to the institution from NIH and Department of Defense and research funds to the institution from the CDC, bioMerieux, AstraZeneca, AbbVie, Entegrion Inc, and Endpoint Health outside the submitted work; having a patent for risk stratification in sepsis and septic shock issued to Cincinnati Children's Hospital Medical Center; and having stock options in Bioscape Digital unrelated to the current work. Dr Stewart reported receiving grants from Duke University as a subaward for ACTIV-6 from NIH during the conduct of the study and grants from NIH supported by grants from NCATS and NIDDK and research support from the Abdominal Core Health Quality Collaborative, a 501(c)(3) nonprofit organization, outside the submitted work. Dr Lim reported receiving a subaward from NCATS to the institution during the conduct of the study. Dr Gentile reported receiving personal fees from Duke University for ACTIV-6 protocol development committee membership during the conduct of the study. Dr Felker reported receiving grants from NIH during the conduct of the study. Dr Jayaweera reported receiving grants from NCATS during the conduct of the study and grants from Gilead, ViiV Healthcare, and Janssen and personal fees from Theratechnologies outside the submitted work. Dr Sulkowski reported receiving grants to the institution from Janssen, Vir, and GSK; personal fees for serving on a scientific advisory board from GSK, AbbVie, Antios, Assembly Bio, Atea, Gilead; personal fees for serving on a data and safety monitoring board from Precision Bio and Immunocore; personal fees as an editor for Journal of Viral Hepatitis ; and personal fees from NIH (K24DA034621) outside the submitted work. Dr Rothman reported receiving grants from the NIH during the conduct of the study and spouse owning a small amount of stock in Moderna. Dr Wilson reported receiving grants from NCATS (3U24TR001608) during the conduct of the study. Dr DeLong reported receiving grants from NCATS (3U24TR001608) during the conduct of the study. Dr Collins reported receiving grants from NCATS during the conduct of the study and personal fees from Vir Biotechnology and Enanta Pharmaceuticals and grants from NHLBI outside the submitted work. Dr Adam reported receiving US Government funding through Operation Warp Speed during the conduct of the study. Dr Hanna reported receiving grants from US Biomedical Advanced Research & Development Authority contract to Tunnell Government Services for consulting services during the conduct of the study and personal fees from Merck & Co and AbPro outside the submitted work. Dr Ginde reported receiving contracts from NIH during the conduct of the study and grants from NIH, Centers for Disease Control and Prevention, Department of Defense, Faron Pharmaceuticals, and AbbVie outside the submitted work. Dr Castro reported receiving grants from NIH during the conduct of the study and grants from ALA, PCORI, AstraZeneca, Gala Therapeutics, Genentech, GSK, Novartis, Pulmatrix, Sanofi-Aventis, Shionogi, and Theravance and personal fees from Genentech, Teva, Sanofi-Aventis, Merck, Novartis, Arrowhead, Allakos, Amgen, OM Pharma, Pfizer, Pioneering Medicines, GSK, and Regeneron and having stock options in Aer Therapeutics outside the submitted work. Dr McTigue reported receiving grants from University of Pittsburgh for ACTIV-6 research funding during the conduct of the study. Dr Hernandez reported receiving grants from AstraZeneca, Merck, and Pfizer outside the submitted work. No other disclosures were reported.

Funding/Support: ACTIV-6 is funded by the NCATS (3U24TR001608-06S1). Additional support for this study was provided by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (contract No.75A50122C00037). The Vanderbilt University Medical Center Clinical and Translational Science Award from NCATS (UL1TR002243) supported the REDCap infrastructure.

Role of the Funder/Sponsor: NCATS participated in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement : See Supplement 5 .

Additional Contributions: We thank Samuel Bozzette, MD, PhD, and Eugene Passamani, MD (National Center for Advancing Translational Sciences), for their roles in the trial design and protocol development. We also thank the ACTIV-6 data monitoring committee and clinical events committee members for their contributions: data monitoring committee : Clyde Yancy, MD, MSc (Northwestern University Feinberg School of Medicine); Adaora Adimora, MD (University of North Carolina, Chapel Hill); Susan Ellenberg, PhD (University of Pennsylvania); Kaleab Abebe, PhD (University of Pittsburgh); Arthur Kim, MD (Massachusetts General Hospital); John D. Lantos, MD (Children’s Mercy Hospital); Jennifer Silvey-Cason (participant representative); Frank Rockhold, PhD (Duke Clinical Research Institute); Sean O’Brien, PhD (Duke Clinical Research Institute); Frank Harrell, PhD (Vanderbilt University Medical Center); Zhen Huang, MS (Duke Clinical Research Institute); clinical events committee : Renato Lopes, MD, PhD, MHS; W. Schuyler Jones, MD; Antonio Gutierrez, MD; Robert Harrison, MD; David Kong, MD; Robert McGarrah, MD; Michelle Kelsey, MD; Konstantin Krychtiuk, MD; Vishal Rao, MD (Duke Clinical Research Institute, Duke University School of Medicine). Elizabeth E.S. Cook ( Duke Clinical Research Institute) provided editorial support.

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UAV Coverage Path Planning With Limited Battery Energy Based on Improved Deep Double Q-network

• Regular Papers
• Robot and Applications
• Published: 02 August 2024
• Volume 22 , pages 2591–2601, ( 2024 )

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• Jianjun Ni   ORCID: orcid.org/0000-0002-7130-8331 1 , 2 ,
• Yu Gu   ORCID: orcid.org/0000-0002-4315-673X 1 ,
• Yang Gu   ORCID: orcid.org/0000-0002-6698-479X 1 ,
• Yonghao Zhao   ORCID: orcid.org/0009-0003-6810-8675 1 &
• Pengfei Shi   ORCID: orcid.org/0000-0002-2966-1676 1 , 2  

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In response to the increasingly complex problem of patrolling urban areas, the utilization of deep reinforcement learning algorithms for autonomous unmanned aerial vehicle (UAV) coverage path planning (CPP) has gradually become a research hotspot. CPP’s solution needs to consider several complex factors, including landing area, target area coverage and limited battery capacity. Consequently, based on incomplete environmental information, policy learned by sample inefficient deep reinforcement learning algorithms are prone to getting trapped in local optima. To enhance the quality of experience data, a novel reward is proposed to guide UAVs in efficiently traversing the target area under battery limitations. Subsequently, to improve the sample efficiency of deep reinforcement learning algorithms, this paper introduces a novel dynamic soft update method, incorporates the prioritized experience replay mechanism, and presents an improved deep double Q-network (IDDQN) algorithm. Finally, simulation experiments conducted on two different grid maps demonstrate that IDDQN outperforms DDQN significantly. Our method simultaneously enhances the algorithm’s sample efficiency and safety performance, thereby enabling UAVs to cover a larger number of target areas.

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Jianjun Ni, Yu Gu, Yang Gu, Yonghao Zhao & Pengfei Shi

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This work was supported by National Natural Science Foundation of China (61873086), and the National Key R&D Program of China (2022YFB4703402).

Jianjun Ni received his Ph.D. degree from the School of Information and Electrical Engineering from China University of Mining and Technology, Xuzhou, China, in 2005. Currently he is a Professor of College of Artificial Intelligence and Automation, Hohai University, China. He was a Visiting Professor with the Advanced Robotics & Intelligent Systems (ARIS) Laboratory at the University of Guelph in Canada from November 2009 to October 2010. He has published over 100 papers in related international conferences and journals. He serves as an Associate Editor and reviewer of a number of international journals. His research interests include control systems, neural networks, robotics, machine intelligence and multi-agent system.

Yu Gu received his B.S. degree from Hohai University, China, in 2021. Currently, he is working toward an M.S. degree in detection technology and automation devices systems, College of Artificial Intelligence and Automation at Hohai University. His research interests include deep reinforcement learning and coverage path planning.

Yang Gu received his Ph.D. degree in electrical engineering and automation from the China University of Mining and Technology in 2022. He is currently a lecture in the College of Artificial Intelligence and Automation, Hohai University. His research interest includes reinforcement learning.

Yonghao Zhao received his master’s degree from Nanjing Tech University, China, in 2022. Currently, he is working towards a Ph.D. degree in artificial intelligence, College of Artificial Intelligence and Automation, Hohai University. His research interests include machine learning, robot control, and so on.

Pengfei Shi received his B.S. degree from Nanjing University of Information Science and Technology, Nanjing, China, his M.S. and Ph.D. degrees from Hohai University, Nanjing, China, in 2011 and 2016, respectively. He now works in the College of Artificial Intelligence and Automation, Hohai University, Changzhou, China. His research interests include machine learning, machine vision, and underwater detection.

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Ni, J., Gu, Y., Gu, Y. et al. UAV Coverage Path Planning With Limited Battery Energy Based on Improved Deep Double Q-network. Int. J. Control Autom. Syst. 22 , 2591–2601 (2024). https://doi.org/10.1007/s12555-023-0724-9

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Received : 28 October 2023

Revised : 26 January 2024

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Published : 02 August 2024

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DOI : https://doi.org/10.1007/s12555-023-0724-9

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