ACTIV-6: COVID-19 Study of Repurposed Medications - Arm D (Ivermectin 600)
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 (or reinfection) 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 (see Appendices)* Additional Appendix-Level Exclusion Criteria: End-stage renal disease on renal replacement therapy Liver failure or decompensated cirrhosis Current or planned use of the following drugs during the study, listed by drug class: Antiarrhythmic/antihypertensive drug class: quinidine, amiodarone, diltiazem, spironolactone, verapamil Antibiotic-macrolides drug class: clarithromycin, erythromycin Antifungal drug class: itraconazole, ketoconazole Immunosuppressant drug class: cyclosporine, tacrolimus Anti-HIV drug class: indinavir, ritonavir 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
- Arena Medical Group
- 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
- Rush University Medical Center
- 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
- 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
- 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
- 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 Virginia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm D - Ivermectin 600
Arm D - Placebo
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.