MedTrace Logo

Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2)

NCT04668950 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2022-10-31

Study results available
· View outcomes & findings →

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.

Conditions

  • Covid19
  • Coronavirus

Interventions

DRUG

Fluvoxamine

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Covid-19 Early Treatment Fund

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • Cures Within Reach

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2021-09-28
Completion
2021-09-28
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04668950 on ClinicalTrials.gov