AzTrials
AzTrials

Covid19Phase 3NCT04885530

ACTIV-6: COVID-19 Study of Repurposed Medications

A Phase 3 study testing Ivermectin, Fluvoxamine and Fluticasone in people with Covid19, run by Susanna Naggie, MD at 110 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Covid19
What is being tested?
Ivermectin, Fluvoxamine and Fluticasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,956 participants
Where
110 sitesUnited States
Study dates
8 Jun 2021to 29 Apr 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completed Informed Consent
  • Age ≥ 30 years old
  • Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
  • Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell

Who cannot join

  • Current or recent (within 10 days of screening) hospitalization for COVID-19 infection
  • Current or planned participation in another interventional trial to treat COVID-19, at the discretion of the study principal investigator (PI)
  • Current or recent use (within the last 14 days) of study drug or study drug/device combination
  • Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo
  • Known contraindication(s) to study drug including prohibited concomitant medications
  • Previous or current enrollment in the ACTIV-6 trial

Trial locations and contacts

110 sites in 1 country.

110 sites in 1 country

United States110 sites

  • Christus Saint Frances Hospita

    Alexandria, Louisiana, 71301

  • Express Family Clinic

    Allen, Texas, 75013

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Emory Healthcare

    Atlanta, Georgia, 30322

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287-1900

  • Focus Clinical Research Solutions

    Bayonne, New Jersey, 07002

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Diabetes and Endocrinology Assoc. of Stark County

    Canton, Ohio, 44718

  • A New Start II, LLC

    Central City, Kentucky, 42330

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Northwestern Univesity

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Olivo Wellness Medical Center

    Chicago, Illinois, 60618

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Vaidya MD PLLC

    Clayton, North Carolina, 27520

  • Geriatrics and Medical Associates

    Clinton, New York, 13323

  • Essential Medical Care, Inc.

    College Park, Georgia, 30349

  • Doctors Medical Group of Colorado Springs, P.C.

    Colorado Springs, Colorado, 80917

  • Pine Ridge Family Medicine Inc.

    Colorado Springs, Colorado, 80924

  • University of Missouri - Columbia

    Columbia, Missouri, 65212

  • Clincept, LLC

    Columbus, Georgia, 31904

  • HOPE Clinical Research and Wellness

    Conyers, Georgia, 30094

  • David Kavtaradze MD, Inc.

    Cordele, Georgia, 31015

  • Ananda Medical Clinic

    Dearborn, Michigan, 48124

  • Arena Medical Group

    Deerfield Beach, Florida, 33441

  • GFC of Southeastern Michigan, PC

    Detroit, Michigan, 48202

  • Romancare Health Services

    Detroit, Michigan, 48206

  • Elite Family Practice

    Douglasville, Georgia, 30134

  • Essentia Health

    Duluth, Minnesota, 55805

  • Maria Medical Center, PLLC

    Dunn, North Carolina, 28334

  • The Heart and Medical Center

    Durant, Oklahoma, 74701

  • Duke Clinical Research Institute

    Durham, North Carolina, 27701

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • DHR Health Institute for Research

    Edinburg, Texas, 78539

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905

  • NorthShore Medical Group

    Evanston, Illinois, 60201

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Texas Health Physicians Group

    Fort Worth, Texas, 76107

  • Clinical Trials Center of Middle TN

    Franklin, Tennessee, 37067

  • Lupus Foundation of Gainesville

    Gainesville, Florida, 32606

  • University of Florida Health

    Gainesville, Florida, 32611

  • Lamb Health, LLC

    Gilbert, Arizona, 85298

  • Comprehensive Pain Management and Endocrinology

    Henderson, Nevada, 89052

  • Rapha Family Wellness

    Hendersonville, Tennessee, 37075

  • L and A Morales Healthcare, Inc

    Hialeah, Florida, 33012

  • Highlands Medical Associates, P.A.

    Highlands, Texas, 77562

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Hugo Medical clinic

    Hugo, Oklahoma, 74743

  • Family Practice Doctors P.A.

    Humble, Texas, 77338

  • Texas Health Physicians Group

    Irving, Texas, 75039

  • University of Florida-JAX-ASCENT

    Jacksonville, Florida, 32209

  • AMRON Vitality and Wellness Center, LLC

    Jacksonville, Florida, 32244

  • Kintex Group Texas LLC, DBA Activian Clinical Research

    Kingwood, Texas, 77339

  • Medical Specialists of Knoxville

    Knoxville, Tennessee, 37938

  • Sunshine Walk In Clinic

    Lake Mary, Florida, 32746

  • Advanced Medical Care, Ltd

    Lake Zurich, Illinois, 60047

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Health Quality Primary Care

    Lawrence, Massachusetts, 01843

  • University of Arkansas Medical Sciences

    Little Rock, Arkansas, 72205

  • Christ the King Health Care, P.C.

    Loganville, Georgia, 30052

  • Miller Family Practice, LLC

    Macon, Georgia, 31201

  • Raritan Bay Primary Care & Cardiology Associates

    Matawan, New Jersey, 07747

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • First Care Medical Clinic

    Mesa, Arizona, 85203

  • Jackson Memorial Hospital

    Miami, Florida, 33136

  • University of Miami

    Miami, Florida, 33136

  • Well Pharma Medical Research

    Miami, Florida, 33173

  • The Angel Medical Research Corporation

    Miami Lakes, Florida, 33016

  • Franciscan Health Michigan City

    Michigan City, Indiana, 46360

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Del Pilar Medical and Urgent Care

    Mishawaka, Indiana, 46545

  • TriHealth, Inc

    Montgomery, Ohio, 45242

  • Lapis Clinical Research

    Mooresville, North Carolina, 28117

  • Bucks County Clinical Research

    Morrisville, Pennsylvania, 19067

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

  • University Medical Center- New Orleans

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Weill Cornell Medical College

    New York, New York, 10065

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Assuta Family Medical Group APMC

    North Hollywood, California, 91606

  • Innovation Clinical Trials Inc.

    Palmetto Bay, Florida, 33157

  • Stanford

    Palo Alto, California, 94304

  • University Diagnostics and Treatment Clinic

    Pasadena, Texas, 77504

  • G&S Medical Associates, LLC

    Paterson, New Jersey, 07514

  • Trident Health Center

    Peoria, Arizona, 85382

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Lice Source Services Plantation

    Plantation, Florida, 33313

  • Jadestone Clinical Research, LLC

    Rockville, Maryland, 20855

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Christus St. Vincent Regional Medical Center

    Santa Fe, New Mexico, 87505

  • Superior Clinical Research

    Smithfield, North Carolina, 27577

  • Providence Medical Research Center

    Spokane, Washington, 99204

  • Premier Health

    St. Petersburg, Florida, 33707

  • Tabitha B. Fortt, M.D., LLC

    Stamford, Connecticut, 06905

  • Jeremy W. Szeto, D.O., P.A.

    Sugar Land, Texas, 77479

  • Olive View - UCLA Medical Center

    Sylmar, California, 91342

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Tampa General Hospital

    Tampa, Florida, 33606

  • UF Health Precision Health Research

    The Villages, Florida, 32159

  • Ascension St. John

    Tulsa, Oklahoma, 74104

  • Mediversity Healthcare

    Turnersville, New Jersey, 08012

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037

  • University of Texas Rio Grande Valley

    Weslaco, Texas, 78596

  • University of Kansas - Wichita

    Wichita, Kansas, 67214

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27151

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

  • Spinal Pain and Medical Rehab, PC

    Yonkers, New York, 10701

Other trials in United States

About this study

Official title: ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person.

Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID.

Pro00107921_A - Arm D (Ivermectin 400) - NCT05736861; Pro00107921_B - Arm B (Fluvoxamine) - NCT05890586; Pro00107921_C - Arm C (Fluticasone) - NCT05736874; Pro00107921_D - Arm D (Ivermectin 600) - NCT05894538; Pro00107921_E - Arm E (Fluvoxamine 100) - NCT05894564; Pro00107921_F - Arm F (Montelukast) - NCT05894577; Pro00107921_G - Arm G (Metformin) - NCT06042855.

Read the detailed description

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting.

This proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization.

This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2.

Participants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo. The probability of placebo to treatment will remain the same regardless of eligibility decisions.

Eligible participants will be randomized (1:1), in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. As additional study drugs are added, the randomization will be altered to leverage placebo data across arms. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized.

All study visits are designed to be remote. However, screening and enrollment may occur in-person at sites and unplanned study visits may occur in-person or remotely, as deemed appropriate by the site investigator for safety purposes. Participants will be asked to complete questionnaires and report safety events during the study. Participants will be prompted by the online system to report safety events and these will be reviewed and confirmed via medical records and site staff, as necessary.

Conditions
Covid19
Being tested
Ivermectin, Fluvoxamine, Fluticasone, Placebo, Montelukast
Keywords
SARS-CoV-2, COVID-19, ivermectin, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, fluticasone, fluvoxamine, ACTIV 6, ACTIV, montelukast, metformin
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvermectinDrug

    Also called Ivermectin Tablets

    Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.

  • FluvoxamineDrug

    Also called Fluvoxamine Maleate Tablets

    Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.

  • FluticasoneDrug

    Also called Fluticasone Furoate

    Fluticasone furoate is an inhaled powder drug product composed of fluticasone furoate. It is a synthetic trifluorinated corticosteroid that is insoluble in water. Fluticasone furoate is a white powder and will be provided in a two tone grey inhaler with a mouthpiece cover and separate foil blister strips. The inhaler will be packaged in a moisture-protective foil tray with a desiccant and a peelable lid.All packaging will be labeled to indicate that the product is for investigational use. Participants will self-administer 200 µg (1 blister) of fluticasone furoate once daily for 14 days.

  • PlaceboOther

    Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.

  • MontelukastDrug

    Montelukast sodium is a white to off-white powder. The 10 mg montelukast tablets are beige, rounded square-shaped, biconvex, film-coated tablets. Each tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg montelukast. All packaging will be labeled to indicate that the product is for investigational use.

  • MetforminDrug

    Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.

Study groups in NCT04885530
Study groupRoleWhat they receive
Arm A - Ivermectin 400ExperimentalIvermectin - 7-mg tablets Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Receives: Drug: Ivermectin
Arm A - PlaceboPlacebo comparatorPlacebo - appearance and size matched to active study drug. Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Receives: Other: Placebo
Arm B - FluvoxamineExperimentalFluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.
Receives: Drug: Fluvoxamine
Arm B- PlaceboPlacebo comparatorPlacebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
Receives: Other: Placebo
Arm C - FluticasoneExperimentalFluticasone is a self-administered inhaled drug. Participants will self-administer 200 µg (1 blister) of fluticasone once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the study drug through the mouthpiece.
Receives: Drug: Fluticasone
Arm C - PlaceboPlacebo comparatorPlacebo is a self-administered by inhalation. Participants will self-administer 1 blister of placebo once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the placebo through the mouthpiece.
Receives: Other: Placebo
Arm D - Ivermectin 600ExperimentalIvermectin - 7-mg tablets Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 µg/kg.
Receives: Drug: Ivermectin
Arm D - PlaceboPlacebo comparatorPlacebo - appearance and size matched to active study drug. Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight, matched to active study drug dosing.
Receives: Other: Placebo
Arm E - Fluvoxamine 100ExperimentalFluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Receives: Drug: Fluvoxamine
Arm E - PlaceboPlacebo comparatorPlacebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Receives: Other: Placebo
Arm F - MontelukastExperimentalMontelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.
Receives: Drug: Montelukast
Arm F - PlaceboPlacebo comparatorPlacebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Receives: Other: Placebo
Arm G - MetforminExperimentalMetformin IR tablets will be self-administered orally according to the following dosing schedule: * 500 mg on Day 1; * 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and * 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Receives: Drug: Metformin
Arm G - PlaceboPlacebo comparatorPlacebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Number of Participants Randomized Within Each Appendix

    Total number of participants randomized within each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT ID.

    Measured: Up to approximately 2 years 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start8 Jun 2021
  3. Primary completion29 Apr 2024
  4. Study completion29 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-Blind, Placebo-Controlled, Randomized Trial
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
10,956 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04885530
Sponsor's protocol ID
Pro00107921
Other IDs
3U24TR001608-05W1
Status last verified
Nov 2025
First submitted
30 Apr 2021
Last updated
17 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: We will share this data after it has been de-identified. We will share data beginning around 6 months after publication and for up to 36 months afterward. Access will only be shared with those who have obtained prior IRB approval to be able to access this data.

Publications

  • Bramante CT, Stewart TG, Boulware DR, McCarthy MW, Gao Y, Rothman RL, Mourad A, Thicklin F, Cohen JB, Garcia Del Sol IT, Ruiz-Unger J, Shah NS, Mehta M, Cardona OQ, Scott J, Ginde AA, Castro M, Jayaweera D, Sulkowski M, Gentile N, McTigue K, Felker GM, Collins S, Dunsmore SE, Adam SJ, Lindsell CJ, Hernandez AF, Naggie S; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators. Metformin on Time to Sustained Recovery in Adults with COVID-19: The ACTIV-6 Randomized Clinical Trial. medRxiv [Preprint]. 2025 Jan 14:2025.01.13.25320485. doi: 10.1101/2025.01.13.25320485.

    PubMed 41030935

  • Bramante CT, Stewart TG, Boulware DR, McCarthy MW, Gao Y, Rothman RL, Mourad A, Thicklin F, Cohen JB, Garcia Del Sol IT, Shah NS, Mehta M, Quintero Cardona O, Scott J, Ginde AA, Castro M, Jayaweera D, Sulkowski M, Gentile N, McTigue K, Felker GM, Collins S, Dunsmore SE, Adam SJ, Lindsell CJ, Hernandez AF, Naggie S; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators. Metformin on the Presence of COVID-19 Symptoms Over 6 Months: The ACTIV-6 Randomized Clinical Trial. medRxiv [Preprint]. 2025 Aug 12:2025.08.08.25333305. doi: 10.1101/2025.08.08.25333305.

    PubMed 40832427

  • Bramante CT, Stewart TG, Boulware DR, McCarthy MW, Gao Y, Rothman RL, Mourad A, Thicklin F, Cohen JB, Garcia Del Sol IT, Ruiz-Unger J, Shah NS, Mehta M, Cardona OQ, Scott J, Ginde AA, Castro M, Jayaweera D, Sulkowski M, Gentile N, McTigue K, Felker GM, Collins S, Dunsmore SE, Adam SJ, Lindsell CJ, Hernandez AF, Naggie S; Accelerating COVID-19 Therapeutic Interventions and Vaccines-6 Study Group and Investigators. Metformin and Time to Sustained Recovery in Adults With COVID-19: The ACTIV-6 Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1092-1101. doi: 10.1001/jamainternmed.2025.2570.

    PubMed 40658388

  • Rothman RL, Stewart TG, Mourad A, Boulware DR, McCarthy MW, Thicklin F, Garcia Del Sol IT, Garcia JL, Bramante CT, Shah NS, Singh U, Williamson JC, Rebolledo PA, Jagannathan P, Schwasinger-Schmidt T, Ginde AA, Castro M, Jayaweera D, Sulkowski M, Gentile N, McTigue K, Felker GM, DeLong A, Wilder R, Collins S, Dunsmore SE, Adam SJ, Hanna GJ, Shenkman E, Hernandez AF, Naggie S, Lindsell CJ; Accelerating COVID-19 Therapeutic Interventions and Vaccines-6 Study Group and Investigators. Time to Sustained Recovery Among Outpatients With COVID-19 Receiving Montelukast vs Placebo: The ACTIV-6 Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2439332. doi: 10.1001/jamanetworkopen.2024.39332.

    PubMed 39422912

  • Rothman RL, Stewart TG, Mourad A, Boulware DR, McCarthy MW, Thicklin F, Garcia Del Sol IT, Garcia JL, Bramante CT, Shah NS, Singh U, Williamson JC, Rebolledo PA, Jagannathan P, Schwasinger-Schmidt T, Ginde AA, Castro M, Jayaweera D, Sulkowski M, Gentile N, McTigue K, Felker GM, DeLong A, Wilder R, Collins S, Dunsmore SE, Adam SJ, Hanna GJ, Shenkman E, Hernandez AF, Naggie S, Lindsell CJ; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators. Effect of Montelukast vs Placebo on Time to Sustained Recovery in Outpatients with COVID-19: The ACTIV-6 Randomized Clinical Trial. medRxiv [Preprint]. 2024 May 18:2024.05.16.24307115. doi: 10.1101/2024.05.16.24307115.

    PubMed 38798524

  • Stewart TG, Rebolledo PA, Mourad A, Lindsell CJ, Boulware DR, McCarthy MW, Thicklin F, Garcia Del Sol IT, Bramante CT, Lenert LA, Lim S, Williamson JC, Cardona OQ, Scott J, Schwasinger-Schmidt T, Ginde AA, Castro M, Jayaweera D, Sulkowski M, Gentile N, McTigue K, Felker GM, DeLong A, Wilder R, Rothman RL, Collins S, Dunsmore SE, Adam SJ, Hanna GJ, Shenkman E, Hernandez AF, Naggie S; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators. Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19: The ACTIV-6 Randomized Clinical Trial. JAMA. 2023 Dec 26;330(24):2354-2363. doi: 10.1001/jama.2023.23363.

    PubMed 37976072

  • Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators; Naggie S. Effect of Higher-Dose Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients with Mild to Moderate COVID-19: A Randomized Clinical Trial. medRxiv [Preprint]. 2023 Sep 13:2023.09.12.23295424. doi: 10.1101/2023.09.12.23295424.

    PubMed 37745371

  • Boulware DR, Lindsell CJ, Stewart TG, Hernandez AF, Collins S, McCarthy MW, Jayaweera D, Gentile N, Castro M, Sulkowski M, McTigue K, Felker GM, Ginde AA, Dunsmore SE, Adam SJ, DeLong A, Hanna G, Remaly A, Thicklin F, Wilder R, Wilson S, Shenkman E, Naggie S; ACTIV-6 Study Group and Investigators. Inhaled Fluticasone Furoate for Outpatient Treatment of Covid-19. N Engl J Med. 2023 Sep 21;389(12):1085-1095. doi: 10.1056/NEJMoa2209421.

    PubMed 37733308

  • Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Slandzicki AJ, Lim SC, Cohen J, Kavtaradze D, Amon AP, Gabriel A, Gentile N, Felker GM, Jayaweera D, McCarthy MW, Sulkowski M, Rothman RL, Wilson S, DeLong A, Remaly A, Wilder R, Collins S, Dunsmore SE, Adam SJ, Thicklin F, Hanna GJ, Ginde AA, Castro M, McTigue K, Shenkman E, Hernandez AF; Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators. 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 Mar 21;329(11):888-897. doi: 10.1001/jama.2023.1650.

    PubMed 36807465

  • McCarthy MW, Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Felker GM, Jayaweera D, Sulkowski M, Gentile N, Bramante C, Singh U, Dolor RJ, Ruiz-Unger J, Wilson S, DeLong A, Remaly A, Wilder R, Collins S, Dunsmore SE, Adam SJ, Thicklin F, Hanna G, Ginde AA, Castro M, McTigue K, Shenkman E, Hernandez AF; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators. Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2023 Jan 24;329(4):296-305. doi: 10.1001/jama.2022.24100.

    PubMed 36633838

  • Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Lim SC, Cohen J, Kavtaradze D, Amon AP, Gabriel A, Gentile N, Felker GM, Rothman RL, Jayaweera D, McCarthy MW, Sulkowski M, Wilson S, DeLong A, Remaly A, Wilder R, Collins S, Dunsmore SE, Adam SJ, Thicklin F, Hanna GJ, Ginde AA, Castro M, McTigue K, Shenkman E, Hernandez AF; Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators. Effect of Ivermectin 600 mug/kg for 6 days vs Placebo on Time to Sustained Recovery in Outpatients with Mild to Moderate COVID-19: A Randomized Clinical Trial. medRxiv [Preprint]. 2022 Dec 15:2022.12.15.22283488. doi: 10.1101/2022.12.15.22283488.

    PubMed 36561174

  • Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Gentile N, Collins S, McCarthy MW, Jayaweera D, Castro M, Sulkowski M, McTigue K, Thicklin F, Felker GM, Ginde AA, Bramante CT, Slandzicki AJ, Gabriel A, Shah NS, Lenert LA, Dunsmore SE, Adam SJ, DeLong A, Hanna G, Remaly A, Wilder R, Wilson S, Shenkman E, Hernandez AF; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) Study Group and Investigators. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Oct 25;328(16):1595-1603. doi: 10.1001/jama.2022.18590.

    PubMed 36269852

  • Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group; Naggie S. Ivermectin for Treatment of Mild-to-Moderate COVID-19 in the Outpatient Setting: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial. medRxiv [Preprint]. 2022 Aug 11:2022.06.10.22276252. doi: 10.1101/2022.06.10.22276252.

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  • Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group; Naggie S. Inhaled Fluticasone for Outpatient Treatment of Covid-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial. medRxiv [Preprint]. 2022 Aug 11:2022.07.12.22277548. doi: 10.1101/2022.07.12.22277548.

    PubMed 35982649

  • Dodds MG, Doyle EB, Reiersen AM, Brown F, Rayner CR. Fluvoxamine for the treatment of COVID-19. Lancet Glob Health. 2022 Mar;10(3):e332. doi: 10.1016/S2214-109X(22)00006-7. No abstract available.

    PubMed 35180412

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ivermectin, Fluvoxamine and Fluticasone in people with Covid19, run by Susanna Naggie, MD at 110 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Participants Randomized Within Each Appendix (time frame: Up to approximately 2 years 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04885530, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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