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Arm E - Fluvoxamine 100 for Coronavirus

Phase 3
Waitlist Available
Led By Adrian Hernandez, MD
Research Sponsored by Susanna Naggie, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7, 14, 28, 90, and 120
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7, 14, 28, 90, and 120
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, 14, 28, 90, and 120 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Sustained Recovery in Days
Secondary study objectives
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
+10 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm E - Fluvoxamine 100Experimental Treatment1 Intervention
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Group II: Arm E - PlaceboPlacebo Group1 Intervention
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluvoxamine
2020
Completed Phase 4
~3259220

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterOTHER
901 Previous Clinical Trials
937,474 Total Patients Enrolled
Susanna Naggie, MDLead Sponsor
7 Previous Clinical Trials
37,450 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
362 Previous Clinical Trials
411,276 Total Patients Enrolled
~381 spots leftby Nov 2025