Phase 3 N=1,331 Randomized Double-blind Treatment

ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine)

Covid19

Bottom Line

View on ClinicalTrials.gov: NCT05890586 ↗

Enrolled (actual)

1,331

Serious AEs

0.7%

Results posted

Aug 2023

Primary outcome: Primary: Time to Sustained Recovery in Days — 12; 13 days

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fluvoxamine (Drug); Placebo (Other)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Susanna Naggie, MD
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Sustained Recovery in Days	12; 13	—
SECONDARY Number of Participants With Hospitalization or Death	1; 3	—
SECONDARY Number of Participants With Mortality	0; 0	—
SECONDARY Time to Mortality	NA; NA	—
SECONDARY Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death	27; 26	—
SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7	55; 34; 542; 511; 45; 33	—
SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14	39; 37; 574; 518; 23; 21	—
SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28	40; 30; 569; 528; 21; 12	—
SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function	20; 20; 20; 20; 20; 20	—
SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue	8; 8; 7; 7; 4.5; 4	—
SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Pain	4; 4; 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	16.5; 18; 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	11.21; 11.28	—
SECONDARY Mean Days Benefit as Measured by the Symptom and Clinical Event Scale	3.45; 3.37	—

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 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
Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo
Known contraindication(s) to study drug including prohibited concomitant medications

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05890586). 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.