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

• Status: Completed
• Trial end date: 2020-12-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Fluvoxamine

Criteria

Inclusion Criteria:

1. men and woman age 18 and older;

2. Not hospitalized;

3. Has recently tested SARS-CoV-2 (COVID-19 virus) positive.

4. 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.

5. Able to provide informed consent.

Exclusion Criteria:

1. Illness severe enough to require hospitalization or already meeting study's primary endpoint for clinical worsening.

2. 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).

3. Immunocompromised (solid organ transplant, BMT, AIDS, on biologics and/or high dose steroids (>20mg prednisone per day)

4. Unable to provide informed consent (eg moderate-severe dementia diagnosis)

5. Unable to perform the study procedures