Status:
COMPLETED
A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection
Lead Sponsor:
Washington University School of Medicine
Conditions:
COVID 19
Coronavirus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
We will consent approximately 152 participants, age 18 and older, who have tested tested positive for COVID-19 and are currently experiencing mild symptoms. All interactions for this study will be con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2020
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04342663
Start Date
April 10 2020
End Date
December 12 2020
Last Update
July 9 2021
Active Locations (2)
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1
BJC
Belleville, Illinois, United States, 62220
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110