ACTIV-6: COVID-19 Study of Repurposed Medications
Covid19
About this trial
This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, COVID-19, ivermectin, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, fluticasone, fluvoxamine, ACTIV 6, ACTIV, montelukast, metformin
Eligibility 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:
- 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
Sites / Locations
- Chandler Regional Medical Center
- Lamb Health, LLC
- First Care Medical Clinic
- Trident Health Center
- University of Arkansas Medical Sciences
- Hoag Memorial Hospital Presbyterian
- Assuta Family Medical Group APMC
- Stanford
- Olive View - UCLA Medical Center
- Doctors Medical Group of Colorado Springs, P.C.
- Pine Ridge Family Medicine Inc.
- Tabitha B. Fortt, M.D., LLC
- George Washington University Hospital
- Arena Medical Group
- Lupus Foundation of Gainesville
- University of Florida Health
- L and A Morales Healthcare, Inc
- University of Florida-JAX-ASCENT
- AMRON Vitality and Wellness Center, LLC
- Sunshine Walk In Clinic
- Lakeland Regional Medical Center
- The Angel Medical Research Corporation
- Jackson Memorial Hospital
- University of Miami
- Well Pharma Medical Research
- Innovation Clinical Trials Inc.
- Lice Source Services Plantation
- Premier Health
- Tallahassee Memorial Hospital
- Tampa General Hospital
- UF Health Precision Health Research
- Morehouse School of Medicine
- Emory Healthcare
- Essential Medical Care, Inc.
- Clincept, LLC
- HOPE Clinical Research and Wellness
- David Kavtaradze MD, Inc.
- Elite Family Practice
- Christ the King Health Care, P.C.
- Miller Family Practice, LLC
- Northwestern Univesity
- Rush University Medical Center
- Olivo Wellness Medical Center
- NorthShore Medical Group
- Advanced Medical Care, Ltd
- Loyola University Medical Center
- Franciscan Health Michigan City
- Del Pilar Medical and Urgent Care
- University of Kansas - Wichita
- A New Start II, LLC
- Christus Saint Frances Hospita
- University Medical Center- New Orleans
- Ochsner Clinic Foundation
- Johns Hopkins Hospital
- Jadestone Clinical Research, LLC
- Boston Medical Center
- Health Quality Primary Care
- University of Massachusetts Medical School
- Ananda Medical Clinic
- GFC of Southeastern Michigan, PC
- Romancare Health Services
- Essentia Health
- University of Minnesota
- University of Missouri - Columbia
- Comprehensive Pain Management and Endocrinology
- Focus Clinical Research Solutions
- Raritan Bay Primary Care & Cardiology Associates
- G&S Medical Associates, LLC
- Mediversity Healthcare
- Christus St. Vincent Regional Medical Center
- Geriatrics and Medical Associates
- Weill Cornell Medical College
- Spinal Pain and Medical Rehab, PC
- Vaidya MD PLLC
- Maria Medical Center, PLLC
- Duke Clinical Research Institute
- Duke University Medical Center
- Lapis Clinical Research
- Superior Clinical Research
- Wake Forest Baptist Health
- Diabetes and Endocrinology Assoc. of Stark County
- University of Cincinnati
- TriHealth, Inc
- The Heart and Medical Center
- Hugo Medical clinic
- Ascension St. John
- Bucks County Clinical Research
- Temple University Hospital
- University of Pittsburgh
- Medical University of South Carolina
- Clinical Trials Center of Middle TN
- Rapha Family Wellness
- Medical Specialists of Knoxville
- Vanderbilt University Medical Center
- Express Family Clinic
- DHR Health Institute for Research
- Texas Tech University Health Sciences Center
- Brooke Army Medical Center
- Texas Health Physicians Group
- Highlands Medical Associates, P.A.
- University of Texas Health Science Center at Houston
- Family Practice Doctors P.A.
- Texas Health Physicians Group
- Kintex Group Texas LLC, DBA Activian Clinical Research
- University Diagnostics and Treatment Clinic
- University of Texas Health Science Center at San Antonio
- Jeremy W. Szeto, D.O., P.A.
- University of Texas Rio Grande Valley
- University of Virginia
- Providence Medical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm A - Ivermectin 400
Arm A - Placebo
Arm B - Fluvoxamine
Arm B- Placebo
Arm C - Fluticasone
Arm C - Placebo
Arm D - Ivermectin 600
Arm D - Placebo
Arm E - Fluvoxamine 100
Arm E - Placebo
Arm F - Montelukast
Arm F - Placebo
Arm G - Metformin
Arm G - Placebo
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 - 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.
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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 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.
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 - 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.
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 - 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.
Montelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.
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.
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.
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.