Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
10956 participants
INTERVENTIONAL
2021-06-08
2024-04-29
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A - Ivermectin 400
Ivermectin - 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.
Ivermectin
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.
Arm A - Placebo
Placebo - 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.
Placebo
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.
Arm B - Fluvoxamine
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.
Fluvoxamine
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.
Arm B- Placebo
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
Placebo
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.
Arm C - Fluticasone
Fluticasone 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.
Fluticasone
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.
Arm C - Placebo
Placebo 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.
Placebo
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.
Arm D - Ivermectin 600
Ivermectin - 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.
Ivermectin
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.
Arm D - Placebo
Placebo - 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.
Placebo
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.
Arm E - Fluvoxamine 100
Fluvoxamine 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.
Fluvoxamine
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.
Arm E - Placebo
Placebo - 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.
Placebo
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.
Arm F - Montelukast
Montelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.
Montelukast
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.
Arm F - Placebo
Placebo - 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.
Placebo
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.
Arm G - Metformin
Metformin 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.
Metformin
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.
Arm G - Placebo
Placebo - 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.
Placebo
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.
Interventions
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Ivermectin
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.
Fluvoxamine
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.
Fluticasone
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.
Placebo
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.
Montelukast
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.
Metformin
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
Vanderbilt University Medical Center
OTHER
Susanna Naggie, MD
OTHER
Responsible Party
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Susanna Naggie, MD
Associate Professor of Medicine
Principal Investigators
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Susanna Naggie, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Adrian Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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Chandler Regional Medical Center
Chandler, Arizona, United States
Lamb Health, LLC
Gilbert, Arizona, United States
First Care Medical Clinic
Mesa, Arizona, United States
Trident Health Center
Peoria, Arizona, United States
University of Arkansas Medical Sciences
Little Rock, Arkansas, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Assuta Family Medical Group APMC
North Hollywood, California, United States
Stanford
Palo Alto, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
Doctors Medical Group of Colorado Springs, P.C.
Colorado Springs, Colorado, United States
Pine Ridge Family Medicine Inc.
Colorado Springs, Colorado, United States
Tabitha B. Fortt, M.D., LLC
Stamford, Connecticut, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Arena Medical Group
Deerfield Beach, Florida, United States
Lupus Foundation of Gainesville
Gainesville, Florida, United States
University of Florida Health
Gainesville, Florida, United States
L and A Morales Healthcare, Inc
Hialeah, Florida, United States
University of Florida-JAX-ASCENT
Jacksonville, Florida, United States
AMRON Vitality and Wellness Center, LLC
Jacksonville, Florida, United States
Sunshine Walk In Clinic
Lake Mary, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Well Pharma Medical Research
Miami, Florida, United States
The Angel Medical Research Corporation
Miami Lakes, Florida, United States
Innovation Clinical Trials Inc.
Palmetto Bay, Florida, United States
Lice Source Services Plantation
Plantation, Florida, United States
Premier Health
St. Petersburg, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
UF Health Precision Health Research
The Villages, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Emory Healthcare
Atlanta, Georgia, United States
Essential Medical Care, Inc.
College Park, Georgia, United States
Clincept, LLC
Columbus, Georgia, United States
HOPE Clinical Research and Wellness
Conyers, Georgia, United States
David Kavtaradze MD, Inc.
Cordele, Georgia, United States
Elite Family Practice
Douglasville, Georgia, United States
Christ the King Health Care, P.C.
Loganville, Georgia, United States
Miller Family Practice, LLC
Macon, Georgia, United States
Northwestern Univesity
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Olivo Wellness Medical Center
Chicago, Illinois, United States
NorthShore Medical Group
Evanston, Illinois, United States
Advanced Medical Care, Ltd
Lake Zurich, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Franciscan Health Michigan City
Michigan City, Indiana, United States
Del Pilar Medical and Urgent Care
Mishawaka, Indiana, United States
University of Kansas - Wichita
Wichita, Kansas, United States
A New Start II, LLC
Central City, Kentucky, United States
Christus Saint Frances Hospita
Alexandria, Louisiana, United States
University Medical Center- New Orleans
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Jadestone Clinical Research, LLC
Rockville, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Health Quality Primary Care
Lawrence, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Ananda Medical Clinic
Dearborn, Michigan, United States
GFC of Southeastern Michigan, PC
Detroit, Michigan, United States
Romancare Health Services
Detroit, Michigan, United States
Essentia Health
Duluth, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Missouri - Columbia
Columbia, Missouri, United States
Comprehensive Pain Management and Endocrinology
Henderson, Nevada, United States
Focus Clinical Research Solutions
Bayonne, New Jersey, United States
Raritan Bay Primary Care & Cardiology Associates
Matawan, New Jersey, United States
G&S Medical Associates, LLC
Paterson, New Jersey, United States
Mediversity Healthcare
Turnersville, New Jersey, United States
Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States
Geriatrics and Medical Associates
Clinton, New York, United States
Weill Cornell Medical College
New York, New York, United States
Spinal Pain and Medical Rehab, PC
Yonkers, New York, United States
Vaidya MD PLLC
Clayton, North Carolina, United States
Maria Medical Center, PLLC
Dunn, North Carolina, United States
Duke Clinical Research Institute
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Lapis Clinical Research
Mooresville, North Carolina, United States
Superior Clinical Research
Smithfield, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Diabetes and Endocrinology Assoc. of Stark County
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
TriHealth, Inc
Montgomery, Ohio, United States
The Heart and Medical Center
Durant, Oklahoma, United States
Hugo Medical clinic
Hugo, Oklahoma, United States
Ascension St. John
Tulsa, Oklahoma, United States
Bucks County Clinical Research
Morrisville, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Clinical Trials Center of Middle TN
Franklin, Tennessee, United States
Rapha Family Wellness
Hendersonville, Tennessee, United States
Medical Specialists of Knoxville
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Express Family Clinic
Allen, Texas, United States
DHR Health Institute for Research
Edinburg, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Texas Health Physicians Group
Fort Worth, Texas, United States
Highlands Medical Associates, P.A.
Highlands, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Family Practice Doctors P.A.
Humble, Texas, United States
Texas Health Physicians Group
Irving, Texas, United States
Kintex Group Texas LLC, DBA Activian Clinical Research
Kingwood, Texas, United States
University Diagnostics and Treatment Clinic
Pasadena, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Jeremy W. Szeto, D.O., P.A.
Sugar Land, Texas, United States
University of Texas Rio Grande Valley
Weslaco, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Providence Medical Research Center
Spokane, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00107921
Identifier Type: -
Identifier Source: org_study_id
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