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NCT04342663 · ClinicalTrials.gov registry record · Phase 2
A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
NCT04342663: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT04342663 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 152 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04342663, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
Study 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.
Primary Outcome
Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (\<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation \>92%.
Interventions
- DRUG Placebo
- DRUG Fluvoxamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2020-04-10 |
| Est. Completion | 2020-12-12 |
| Phase | Phase 2 |
What the finished NCT04342663 record still lists
NCT04342663 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04342663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04342663 about?
NCT04342663 is a clinical study titled "A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection". 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-compulsi...
What is the current status of trial NCT04342663?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2020-04-10. Estimated completion is 2020-12-12.
What interventions are being tested in trial NCT04342663?
The interventions under investigation include: Placebo (DRUG), Fluvoxamine (DRUG).
Who is sponsoring clinical trial NCT04342663?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04342663's enrollment target sits among peer trials
152 452nd of 2000 higher than 1,547 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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