Phase 2
Completed N=152
A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection
COVID · Coronavirus
Source: ClinicalTrials.gov NCT04342663 ↗
Enrolled (actual)
152
Serious AEs
4.6%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Who Met Clinical Worsening — 0; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Met Clinical Worsening |
0; 6 | — |
| SECONDARY Clinical Deterioration on a Likert-type Scale (0-6) |
80; 66; 0; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04342663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.