ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivermectin 400)
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, ACTIV 6, ACTIV
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 Current use 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* [If only one study drug appendix is open at the time of enrollment. If multiple study drug appendices are open, a participant may opt-out of any study drug appendix or be excluded from any study drug appendix based on contraindications listed in the study drug appendix, current use of study drug, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining study drug appendices.] Arm-specific exclusion criteria: End-stage renal disease on renal replacement therapy Liver failure or decompensated cirrhosis Use of warfarin, CYP3A4, P-gp inhibitor drugs, or CYP3A4 substrates Nursing mothers Pregnancy
Sites / Locations
- Lamb Health, LLC
- First Care Medical Clinic
- Trident Health Center
- Hoag Memorial Hospital Presbyterian
- Assuta Family Medical Group APMC
- Stanford
- Doctors Medical Group of Colorado Springs, P.C.
- Pine Ridge Family Medicine Inc.
- Tabitha B. Fortt, M.D., LLC
- George Washington University Hospital
- Lupus Foundation of Gainesville
- University of Florida Health
- University of Florida-JAX-ASCENT
- AMRON Vitality and Wellness Center, LLC
- Sunshine Walk In Clinic
- Lakeland Regional Medical Center
- 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
- Emory Healthcare
- Essential Medical Care, Inc.
- David Kavtaradze MD, Inc.
- Elite Family Practice
- Christ the King Health Care, P.C.
- Miller Family Practice, LLC
- Olivo Wellness Medical Center
- NorthShore Medical Group
- Advanced Medical Care, Ltd
- Franciscan Health Michigan City
- Del Pilar Medical and Urgent Care
- University of Kansas - Wichita
- A New Start II, LLC
- University Medical Center- New Orleans
- Ochsner Clinic Foundation
- Johns Hopkins Hospital
- Jadestone Clinical Research, LLC
- Boston Medical Center
- Health Quality Primary Care
- 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
- Mediversity Healthcare
- 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
- Wake Forest Baptist Health
- Diabetes and Endocrinology Assoc. of Stark County
- University of Cincinnati
- TriHealth, Inc
- The Heart and Medical Center
- Hugo Medical clinic
- 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
- Texas Tech University Health Sciences Center
- Texas Health Physicians Group
- Highlands Medical Associates, P.A.
- University of Texas Health Science Center at Houston
- Family Practice Doctors P.A.
- Vytalus Medical Group
- Texas Health Physicians Group
- University Diagnostics and Treatment Clinic
- University of Texas Health Science Center at San Antonio
- Jeremy W. Szeto, D.O., P.A.
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm A - Ivermectin 400
Arm A - 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.