CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 152 enrolled
Drug / intervention
Fluvoxamine +1 moredrug
Likely dose
Fluvoxamine 300mgfrom 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/NCT04342663
NCT04342663Phase 2Completed

A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection

Washington University School of Medicine·interventional·Posted Apr 13, 2020·Updated Jul 9, 2021

In Brief

A Phase 2 clinical trial evaluating Fluvoxamine and Placebo for COVID 19 and Coronavirus. Completed, enrolled 152 participants across 2 sites.

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. Only residents of Missouri and Illinois may participate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 13, 2020
Enrollment StartApr 10, 2020
Primary CompletionAug 20, 2020
Study CompletionDec 12, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.2 years ago

Interventions

Fluvoxaminedrug

Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.

Placebodrug

Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.