Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04668950|
Recruitment Status : Active, not recruiting
First Posted : December 16, 2020
Last Update Posted : May 21, 2021
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. People around the United States and Canada can participate.
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Coronavirus||Drug: Fluvoxamine Drug: Placebo||Phase 3|
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 States and Canada can participate. All interactions for this study will be conducted remotely by videoconferencing, email, or phone.
Screening: All participants will first complete a pre-screen to see if they may be eligible for the study. Once a participant is confirmed eligible and consented, the study team will send the study materials. These materials will consist of study medication and self-monitoring equipment, including an oxygen saturation monitor, blood pressure monitor, and thermometer.
RCT: Participants will be randomly assigned (1:1) to take either fluvoxamine or a placebo. This phase of the study will last approximately 15 days and is double-blinded. Participants will take up to 100mg of fluvoxamine or placebo by mouth twice a day for a daily total of 200mg. Participants will continue this dose for approximately 15 days. Depending on tolerability, the dose may be adjusted. Participants will also complete short 5 minute assessments daily to report the results of self-monitoring (including oxygen level, blood pressure, and temperature), a shortness of breath rating and any adverse events.
Follow-up Phase: The study team will follow participants for approximately 90 days after the end of the randomized phase. If needed, the study team will review medical records to determine the clinical course of participants.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Fluvoxamine for Early Treatment of Covid-19: a Fully-remote, Randomized Placebo Controlled Trial|
|Actual Study Start Date :||December 22, 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||September 2021|
Start fluvoxamine 50mg capsule once, then 100mg twice daily. May reduce dose for tolerability reasons. Will be followed in the RCT for approximately 15 days.
Up to 200mg per day (2 capsules per day) as tolerated, for approximately 15 days
Other Name: Luvox
Placebo Comparator: Placebo
Start placebo one capsule, twice daily. May reduce dose for tolerability reasons. Will be followed in RCT for approximately 15 days.
Will take 2 capsules per day as tolerated for approximately 15 days
- Clinical deterioration [ Time Frame: RCT-approximately 15 days ]Defined as both of the following: 1)Presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, 2)) decrease in O2 saturation (<92% on room air) and/or supplemental oxygen requirement to keep O2 saturation ≥92%).
- Post Covid Functioning [ Time Frame: Day 15 and Day 90 ]Self report post Covid Functioning using the PROMIS Global Health Scale. It is a 10-item patient-reported questionnaire in which the response options are presented as 5-point, and one 11-point, rating scales. Higher scores indicate better health.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668950
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84108|
|United States, Washington|
|Seattle, Washington, United States, 98109|
|McGill University Health Center|
|Montreal, Quebec, Canada, H4A3S9|