ACTIV-6: COVID-19 Study of Repurposed Medications
Purpose
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.
Condition
- Covid19
Eligibility
- Eligible Ages
- Over 30 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- Prior diagnosis of COVID-19 infection (> 10 days from screening) - Current or recent (within 10 days of screening) hospitalization - Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo - Known contraindication(s) to study drug including prohibited concomitant medications
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double-Blind, Placebo-Controlled, Randomized Trial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
- Masking Description
- The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo because they will be matching.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Placebo Comparator 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. |
|
|
Experimental Arm B - Fluvoxamine |
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days. |
|
|
Placebo Comparator 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. |
|
|
Experimental 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. |
|
|
Placebo Comparator 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. |
|
|
Experimental 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. |
|
|
Placebo Comparator 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. |
|
|
Experimental 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. |
|
|
Placebo Comparator 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. |
|
|
Experimental Arm F - Montelukast |
Montelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days. |
|
|
Placebo Comparator 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. |
|
Recruiting Locations
Chandler, Arizona 85224
Gilbert, Arizona 85298
Amron Harper
480-440-8666
Mesa, Arizona 85203
Peoria, Arizona 85382
Madelyn Rosequist
888-635-0552
Little Rock, Arkansas 72205
Newport Beach, California 92663
North Hollywood, California 91606
Jaya Nataraj
818-760-2800
Sylmar, California 91342
Colorado Springs, Colorado 80917
Colorado Springs, Colorado 80924
Stamford, Connecticut 06905
Washington, District of Columbia 20037
Deerfield Beach, Florida 33441
Sonaly DeAlmeida
954-715-3334
Gainesville, Florida 32606
Gainesville, Florida 32611
Hialeah, Florida 33012
Jacksonville, Florida 32209
Lake Mary, Florida 32746
Lakeland, Florida 33805
Miami Lakes, Florida 33016
Miami, Florida 33136
Miami, Florida 33136
Maria Almanzar
305-243-5157
Miami, Florida 33173
Palmetto Bay, Florida 33157
Plantation, Florida 33313
Arlen Quintero
954-791-0711
Saint Petersburg, Florida 33707
Tallahassee, Florida 32308
The Villages, Florida 32159
Atlanta, Georgia 30322
Igho Ofotokun, MD
404-616-0659
College Park, Georgia 30349
Cordele, Georgia 31015
Douglasville, Georgia 30134
Loganville, Georgia 30052
Macon, Georgia 31201
Chicago, Illinois 60612
Chicago, Illinois 60618
Evanston, Illinois 60201
Nirav Shah, MD
219-201-8712
Lake Zurich, Illinois 60047
Michigan City, Indiana 46360
Mishawaka, Indiana 46545
Wichita, Kansas 67214
Alexandria, Louisiana 71301
New Orleans, Louisiana 70112
New Orleans, Louisiana 70121
Jake Hall
504-842-7413
Baltimore, Maryland 21287-1900
Rockville, Maryland 20855
Boston, Massachusetts 02118
Lawrence, Massachusetts 01843
Worcester, Massachusetts 01655
Dearborn, Michigan 48124
Greg Karawan
407-321-7111
Detroit, Michigan 48202
Detroit, Michigan 48206
Jeffrey Harrison
Duluth, Minnesota 55805
Minneapolis, Minnesota 55455
Columbia, Missouri 65212
Henderson, Nevada 89052
Bayonne, New Jersey 07002
Matawan, New Jersey 07747
Paterson, New Jersey 07514
Turnersville, New Jersey 08012
Santa Fe, New Mexico 87505
Christopher Gallegos
Clinton, New York 13323
New York, New York 10065
Yonkers, New York 10701
Clayton, North Carolina 27520
Dunn, North Carolina 28334
Durham, North Carolina 27701
Durham, North Carolina 27710
833-385-1880
Mooresville, North Carolina 28117
Smithfield, North Carolina 27577
Winston-Salem, North Carolina 27151
John Williamson, PharmD
336-713-3431
Canton, Ohio 44718
Cincinnati, Ohio 45267
Montgomery, Ohio 45242
Durant, Oklahoma 74701
Hugo, Oklahoma 74743
Philadelphia, Pennsylvania 19140
Pittsburgh, Pennsylvania 15213
Charleston, South Carolina 29403
Franklin, Tennessee 37067
Alex Slandzicki, MD
615-205-8351
Hendersonville, Tennessee 37075
Laura Fisher
615-338-5750
Knoxville, Tennessee 37938
Nashville, Tennessee 37203
Edinburg, Texas 78539
El Paso, Texas 79905
Fort Sam Houston, Texas 78234
Fort Worth, Texas 76107
Highlands, Texas 77562
Houston, Texas 77030
Humble, Texas 77338
Kingwood, Texas 77339
Maria Rivon
281-359-3223
Pasadena, Texas 77504
San Antonio, Texas 78229
Sugar Land, Texas 77479
Weslaco, Texas 78596
Spokane, Washington 99204
More Details
- NCT ID
- NCT04885530
- Status
- Recruiting
- Sponsor
- Susanna Naggie, MD
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.