ACTIV-6: COVID-19 Study of Repurposed Medications

November 3, 2025 updated by: Susanna Naggie, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10956

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center
      • Gilbert, Arizona, United States, 85298
        • Lamb Health, LLC
      • Mesa, Arizona, United States, 85203
        • First Care Medical Clinic
      • Peoria, Arizona, United States, 85382
        • Trident Health Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas Medical Sciences
    • California
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • North Hollywood, California, United States, 91606
        • Assuta Family Medical Group APMC
      • Palo Alto, California, United States, 94304
        • Stanford
      • Sylmar, California, United States, 91342
        • Olive View - UCLA Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80917
        • Doctors Medical Group of Colorado Springs, P.C.
      • Colorado Springs, Colorado, United States, 80924
        • Pine Ridge Family Medicine Inc.
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Tabitha B. Fortt, M.D., LLC
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • George Washington University Hospital
    • Florida
      • Deerfield Beach, Florida, United States, 33441
        • Arena Medical Group
      • Gainesville, Florida, United States, 32611
        • University of Florida Health
      • Gainesville, Florida, United States, 32606
        • Lupus Foundation of Gainesville
      • Hialeah, Florida, United States, 33012
        • L and A Morales Healthcare, Inc
      • Jacksonville, Florida, United States, 32209
        • University of Florida-JAX-ASCENT
      • Jacksonville, Florida, United States, 32244
        • AMRON Vitality and Wellness Center, LLC
      • Lake Mary, Florida, United States, 32746
        • Sunshine Walk In Clinic
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Medical Center
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
      • Miami, Florida, United States, 33173
        • Well Pharma Medical Research
      • Miami Lakes, Florida, United States, 33016
        • The Angel Medical Research Corporation
      • Palmetto Bay, Florida, United States, 33157
        • Innovation Clinical Trials Inc.
      • Plantation, Florida, United States, 33313
        • Lice Source Services Plantation
      • St. Petersburg, Florida, United States, 33707
        • Premier Health
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Hospital
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • The Villages, Florida, United States, 32159
        • UF Health Precision Health Research
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine
      • Atlanta, Georgia, United States, 30322
        • Emory Healthcare
      • College Park, Georgia, United States, 30349
        • Essential Medical Care, Inc.
      • Columbus, Georgia, United States, 31904
        • ClinCept, LLC
      • Conyers, Georgia, United States, 30094
        • HOPE Clinical Research and Wellness
      • Cordele, Georgia, United States, 31015
        • David Kavtaradze MD, Inc.
      • Douglasville, Georgia, United States, 30134
        • Elite Family Practice
      • Loganville, Georgia, United States, 30052
        • Christ the King Health Care, P.C.
      • Macon, Georgia, United States, 31201
        • Miller Family Practice, LLC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Univesity
      • Chicago, Illinois, United States, 60618
        • Olivo Wellness Medical Center
      • Evanston, Illinois, United States, 60201
        • Northshore Medical Group
      • Lake Zurich, Illinois, United States, 60047
        • Advanced Medical Care, Ltd
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Franciscan Health Michigan City
      • Mishawaka, Indiana, United States, 46545
        • Del Pilar Medical and Urgent Care
    • Kansas
      • Wichita, Kansas, United States, 67214
        • University of Kansas - Wichita
    • Kentucky
      • Central City, Kentucky, United States, 42330
        • A New Start II, LLC
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Christus Saint Frances Hospita
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center- New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21287-1900
        • Johns Hopkins Hospital
      • Rockville, Maryland, United States, 20855
        • Jadestone Clinical Research, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Lawrence, Massachusetts, United States, 01843
        • Health Quality Primary Care
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Ananda Medical Clinic
      • Detroit, Michigan, United States, 48202
        • GFC of Southeastern Michigan, PC
      • Detroit, Michigan, United States, 48206
        • Romancare Health Services
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri - Columbia
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Pain Management and Endocrinology
    • New Jersey
      • Bayonne, New Jersey, United States, 07002
        • Focus Clinical Research Solutions
      • Matawan, New Jersey, United States, 07747
        • Raritan Bay Primary Care & Cardiology Associates
      • Paterson, New Jersey, United States, 07514
        • G&S Medical Associates, LLC
      • Turnersville, New Jersey, United States, 08012
        • Mediversity Healthcare
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Christus St. Vincent Regional Medical Center
    • New York
      • Clinton, New York, United States, 13323
        • Geriatrics and Medical Associates
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • Yonkers, New York, United States, 10701
        • Spinal Pain and Medical Rehab, PC
    • North Carolina
      • Clayton, North Carolina, United States, 27520
        • Vaidya MD PLLC
      • Dunn, North Carolina, United States, 28334
        • Maria Medical Center, PLLC
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27701
        • Duke Clinical Research Institute
      • Mooresville, North Carolina, United States, 28117
        • Lapis Clinical Research
      • Smithfield, North Carolina, United States, 27577
        • Superior Clinical Research
      • Winston-Salem, North Carolina, United States, 27151
        • Wake Forest Baptist Health
    • Ohio
      • Canton, Ohio, United States, 44718
        • Diabetes and Endocrinology Assoc. of Stark County
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Montgomery, Ohio, United States, 45242
        • TriHealth, Inc
    • Oklahoma
      • Durant, Oklahoma, United States, 74701
        • The Heart and Medical Center
      • Hugo, Oklahoma, United States, 74743
        • Hugo Medical clinic
      • Tulsa, Oklahoma, United States, 74104
        • Ascension St. John
    • Pennsylvania
      • Morrisville, Pennsylvania, United States, 19067
        • Bucks County Clinical Research
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Clinical Trials Center of Middle TN
      • Hendersonville, Tennessee, United States, 37075
        • Rapha Family Wellness
      • Knoxville, Tennessee, United States, 37938
        • Medical Specialists of Knoxville
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center
    • Texas
      • Allen, Texas, United States, 75013
        • Express Family Clinic
      • Edinburg, Texas, United States, 78539
        • DHR Health Institute for Research
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Fort Worth, Texas, United States, 76107
        • Texas Health Physicians Group
      • Highlands, Texas, United States, 77562
        • Highlands Medical Associates, P.A.
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
      • Humble, Texas, United States, 77338
        • Family Practice Doctors P.A.
      • Irving, Texas, United States, 75039
        • Texas Health Physicians Group
      • Kingwood, Texas, United States, 77339
        • Kintex Group Texas LLC, DBA Activian Clinical Research
      • Pasadena, Texas, United States, 77504
        • University Diagnostics and Treatment Clinic
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
      • Sugar Land, Texas, United States, 77479
        • Jeremy W. Szeto, D.O., P.A.
      • Weslaco, Texas, United States, 78596
        • University of Texas Rio Grande Valley
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Medical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Eligibility for overall study are listed below. There may be additional appendix-specific criteria.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • Ivermectin Tablets
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.
Drug: 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.
Other Names:
  • Fluvoxamine Maleate Tablets
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.
Drug: 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.
Other Names:
  • Fluticasone Furoate
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.
Drug: 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.
Other Names:
  • Ivermectin Tablets
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.
Drug: 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.
Other Names:
  • Fluvoxamine Maleate Tablets
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.
Other: 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.
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.
Other: 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.
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.
Other: 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.
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.
Other: 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.
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.
Other: 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.
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.
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.
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.
Other: 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.
Experimental: 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.
Drug: 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.
Placebo Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Participants Randomized Within Each Appendix
Time Frame: Up to approximately 2 years 10 months
Total number of participants randomized within each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT ID.
Up to approximately 2 years 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Mortality
Time Frame: Up to 28 days
Up to 28 days
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
Time Frame: Up to 28 days
Up to 28 days
Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
Time Frame: Up to 14 days
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.
Up to 14 days
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
Time Frame: Up to 14 days
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.
Up to 14 days
Time to mortality
Time Frame: Up to 28 days
Time to mortality was the number of days between drug receipt and death.
Up to 28 days
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
Time Frame: Day 7
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Day 7
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
Time Frame: Day 14
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Day 14
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
Time Frame: Day 28
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Day 28
Time to sustained recovery in Days
Time Frame: Up to 28 days
(If not evaluated as primary endpoint for the given study drug appendix) Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time. The overall effect of each study drug versus matching placebo will be quantified using one of these two primary endpoints, which will be defined and documented per study drug appendix prior to the initial IA: clinical events (hospitalization or death) or time to recovery. The other will be evaluated as a secondary endpoint.
Up to 28 days
Number of Participants With Hospitalization or Death
Time Frame: Up to 28 days
(If not evaluated as primary endpoint for the given study drug appendix)
Up to 28 days
Quality of Life (QOL) as measured by the PROMIS-29 - Physical Function
Time Frame: Day 7, 14, 28, 90, 120, and 180
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.
Day 7, 14, 28, 90, 120, and 180
Quality of Life (QOL) as measured by the PROMIS-29 - Fatigue
Time Frame: Day 7, 14, 28, 90, 120, and 180
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.
Day 7, 14, 28, 90, 120, and 180
Quality of Life (QOL) as measured by the PROMIS-29 - Pain
Time Frame: Day 7, 14, 28, 90, 120, and 180
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain.
Day 7, 14, 28, 90, 120, and 180
Quality of Life (QOL) as measured by the PROMIS-29 - Depression
Time Frame: Day 7, 14, 28, 90, 120, and 180
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domain with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.
Day 7, 14, 28, 90, 120, and 180
Quality of Life (QOL) as measured by the PROMIS-29 - Anxiety
Time Frame: Day 7, 14, 28, 90, 120, and 180
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.
Day 7, 14, 28, 90, 120, and 180
Quality of Life (QOL) as measured by the PROMIS-29 - Social
Time Frame: Day 7, 14, 28, 90, 120, and 180
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.
Day 7, 14, 28, 90, 120, and 180
Quality of Life (QOL) as measured by the PROMIS-29 - Sleep
Time Frame: Day 7, 14, 28, 90, 120, and 180
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.
Day 7, 14, 28, 90, 120, and 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Susanna Naggie, MD

Collaborators

Vanderbilt University Medical Center
National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Susanna Naggie, MD, Duke Clinical Research Institute
  • Principal Investigator: Adrian Hernandez, MD, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

April 29, 2024

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Estimated)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00107921
  • 3U24TR001608-05W1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Up to 36 months after publication

IPD Sharing Access Criteria

Interested investigators will need to seek prior IRB approval before access to any data is granted.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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