Phase 3
N=1,800
ACTIV-6: COVID-19 Study of Repurposed Medications
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04885530 ↗Enrolled (actual)
1,800
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Total Number of Participants Randomized Within Each Appendix — 1800; 1331; 1407; 1459 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ivermectin (Drug); Fluvoxamine (Drug); Fluticasone (Drug); Placebo (Other); Montelukast (Drug); Metformin (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Susanna Naggie, MD
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Participants Randomized Within Each Appendix |
1800; 1331; 1407; 1459; 1208; 1453 | — |
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.
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04885530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.