ACTIV-6: COVID-19 Study of Repurposed Medications - Arm D (Ivermectin 600)

• Status: Completed
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Susanna Naggie, MD
• Collaborators: National Center for Advancing Translational Sciences (NCATS); Vanderbilt University Medical Center
• Treatments: Ivermectin

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

• Immunosuppresant drug class: cyclosporine, tacrolimus

• Anti-HIV drug class: indinavir, ritonavir

• Nursing mothers

• Pregnancy