Phase 3
N=1,459
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm D (Ivermectin 600)
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT05894538 ↗Enrolled (actual)
1,459
Serious AEs
0.7%
Results posted
Sep 2023
Primary outcome: Primary: Time to Sustained Recovery in Days — 11; 12 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ivermectin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Susanna Naggie, MD
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Sustained Recovery in Days |
11; 12 | — |
| SECONDARY Number of Participants With Hospitalization or Death |
7; 2 | — |
| SECONDARY Number of Participants With Mortality |
1; 0 | — |
| SECONDARY Time to Mortality |
NA; NA | — |
| SECONDARY Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death |
39; 42 | — |
| SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7 |
50; 54; 582; 600; 43; 38 | — |
| SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14 |
32; 32; 616; 637; 26; 16 | — |
| SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28 |
12; 19; 628; 635; 20; 10 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function |
19; 20; 20; 20; 20; 20 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue |
9; 9; 7; 7; 5; 5 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Pain |
5; 6; 4; 4; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Depression |
4; 4; 4; 4; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety |
5; 5; 4; 4; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Social |
16; 16; 20; 20; 20; 20 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep |
10; 10; 9; 9; 8; 8 | — |
| SECONDARY Time Unwell in Days as Measured by the Symptom and Clinical Event Scale |
11.24; 11.28 | — |
| SECONDARY Mean Days Benefit as Measured by the Symptom and Clinical Event Scale |
3.39; 3.34 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05894538). 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.