Status:
COMPLETED
Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Covid-19 Early Treatment Fund
McGill University
Conditions:
Covid19
Coronavirus
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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
The investigators will randomize approximately 880 participants, age 30 and older, who have tested tested positive for COVID-19 and are currently experiencing mild symptoms. People around the United S...
Eligibility Criteria
Inclusion
- Men and woman age 30 and older;
- Not currently hospitalized
- Proven SARS-CoV-2 positive (per lab or physician report).
- Currently symptomatic with one or more of the following symptoms: fever, cough, myalgia, mild dyspnea, chest pain, diarrhea, nausea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat, nasal congestion.
- Able to provide informed consent.
- Upon initial screening, participant reports one of the following risk factors for clinical deterioration: age≥40, racial/ethnic group African-American, Hispanic, or Native American (including more than one race), or 1+ of the following medical conditions which increase risk for developing moderate-severe COVID illness: obesity, hypertension, diabetes, heart disease (coronary artery disease, history of myocardial infarction, or heart failure), lung disease (eg asthma, COPD), immune disorder (eg rheumatoid arthritis, lupus).
Exclusion
- Illness severe enough to require hospitalization or already meeting study's primary endpoint for clinical worsening (eg current O2 saturation \<92% on room air, current use of supplemental oxygen to maintain O2 saturation ≥92%).
- Unstable medical comorbidities (eg decompensated cirrhosis), per patient report and/or medical records.
- Immunocompromised from the following: solid organ transplant, BMT, high dose steroids (\>20mg prednisone per day), or tocilizumab
- Already enrolled in another COVID 19 medication trial (not including vaccination or prophylaxis trials)
- Unable to provide informed consent
- Unable to perform the study procedures
- Taking donepezil (rationale: donepezil is a S1R agonist), or sertraline (rationale: sertraline is a strong sigma-1 antagonist).
- Taking warfarin-also known as Coumadin (rationale: increased risk of bleeding), phenytoin (rationale: fluvoxamine inhibits its metabolism), clopidogrel (rationale: fluvoxamine inhibits its metabolism from pro-drug to active drug which raises risk of cardiovascular events), and St John's wort (rationale: fluvoxamine + St John's wort are considered contraindicated because of the risk of serotonin syndrome)
- Taking SSRIs, SNRIs, or tricyclic antidepressants, unless these are at a low dose such that a study investigator concludes that a clinically significant interaction with fluvoxamine (ie either serotonin syndrome or TCA overdose) is unlikely (examples: participant takes escitalopram but only at 5-10mg daily; that dose plus 200mg fluvoxamine would be insufficient to cause serotonin syndrome; or, participant takes amitriptyline but only at 25mg nightly; even if fluvoxamine inhibits its metabolism, it would be an insufficient dose to cause QTc prolongation or problematic side effects).
- Individuals who report they have bipolar disorder or are taking medication for bipolar disorder (lithium, valproate, high-dose antipsychotic), unless the investigator concludes that the risk for mania is unlikely (ie it is doubtful that the patient actually has bipolar disorder).
- Individuals who take alprazolam or diazepam and are unwilling to cut the medication by 25% (rationale: fluvoxamine modestly inhibits the metabolism of these drugs).
- Participants taking theophylline, tizanidine, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by CYP 1A2, which is inhibited by fluvoxamine) will be reviewed with a study investigator and excluded unless the investigator concludes that the risk to the participant is low (this would be unlikely; example: participant takes tizanidine only as needed and is willing to avoid it for the 15 days of the study).
- Received vaccine for COVID-19.
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2021
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT04668950
Start Date
December 22 2020
End Date
September 28 2021
Last Update
October 31 2022
Active Locations (5)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
3
University of Utah
Salt Lake City, Utah, United States, 84108
4
Fred Hutchinson
Seattle, Washington, United States, 98109