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

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID 19, Coronavirus

In brief

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.

Key facts

Study ID

NCT04342663

Run by

Washington University School of Medicine

People needed

152

Starts

2020-04-10

Expected to finish

2020-12-12

Last updated by the study team

2021-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• men and woman age 18 and older;
• Not hospitalized;
• Has recently tested SARS-CoV-2 (COVID-19 virus) positive.
• Currently symptomatic with one or more of one or more of the following symptoms: fever, cough, myalgia, mild dyspnea, diarrhea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat.
• Able to provide informed consent.

You may not qualify if…

• Illness severe enough to require hospitalization or already meeting study's primary endpoint for clinical worsening.
• Unstable medical comorbidities including, but not limited to: Severe underlying lung disease (COPD on home oxygen, interstitial lung disease, pulmonary hypertension), decompensated cirrhosis, Congestive heart failure (stage 3 or 4 per patient report and/or medical records).
• Immunocompromised (solid organ transplant, BMT, AIDS, on biologics and/or high dose steroids (>20mg prednisone per day)
• Unable to provide informed consent (eg moderate-severe dementia diagnosis)
• Unable to perform the study procedures

Where it is running

• BJC — Belleville, Illinois, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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