CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 670 enrolled
Drug / intervention
Fluvoxamine +1 moredrug
Likely dose
Fluvoxamine 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04668950
NCT04668950Phase 3Completed

Fluvoxamine for Early Treatment of Covid-19: a Fully-remote, Randomized Placebo Controlled Trial

Washington University School of Medicine·interventional·Posted Dec 16, 2020·Updated Oct 31, 2022

In Brief

A Phase 3 clinical trial evaluating Fluvoxamine and Placebo for Covid19 and Coronavirus. Completed, enrolled 670 participants across 5 sites in 2 countries.

Detailed Summary

The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. People around the United States and Canada can participate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19, Coronavirus
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 16, 2020
Enrollment StartDec 22, 2020
Primary CompletionSep 28, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.5 years ago

Interventions

Fluvoxaminedrug

Up to 200mg per day (2 capsules per day) as tolerated, for approximately 15 days

Placebodrug

Will take 2 capsules per day as tolerated for approximately 15 days