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.
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 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 a pregnancy test (for females of childbearing age not
using contraception), an oxygen saturation monitor, blood pressure monitor, and thermometer.
Once the study team has finalized the screening process, the participant will begin taking
the study medication.
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 100mg of fluvoxamine or placebo by mouth three times a day for a daily total of
300mg. They will continue this dose for approximately 15 days. Depending on tolerability, the
dose may be adjusted. Participants will also complete short 10-15 minute assessments daily to
assess symptoms, results of self-monitoring (including oxygen level, blood pressure, and
temperature) and any adverse events.
Open-label Phase: After completing the randomization phase, participants will then
participate in an open-label phase (participant will definitely receive fluvoxamine) that
will last up to 15 days. Those randomized to placebo will have the opportunity to try
fluvoxamine during this time. Those randomized to fluvoxamine will continue this medication
while slowly decreasing the drug. The participant may opt out of this phase. The dosage
during this time will be 50-100mg two times daily until discontinuing the drug.
Follow-up Phase: We will follow participants for approximately 30 days after the end of the
randomized phase. If needed, the study team will review medical records to determine the
clinical course of participants.
Drug: Fluvoxamine
Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.
Other Name: Luvox
Drug: Placebo
Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.
Inclusion Criteria:
1. men and woman age 18 and older;
2. Not hospitalized;
3. Has recently tested SARS-CoV-2 (COVID-19 virus) positive.
4. 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.
5. Able to provide informed consent.
Exclusion Criteria:
1. Illness severe enough to require hospitalization or already meeting study's primary
endpoint for clinical worsening.
2. 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).
3. Immunocompromised (solid organ transplant, BMT, AIDS, on biologics and/or high dose
steroids (>20mg prednisone per day)
4. Unable to provide informed consent (eg moderate-severe dementia diagnosis)
5. Unable to perform the study procedures
BJC
Belleville, Illinois, United States
Washington University School of Medicine
Saint Louis, Missouri, United States
Eric J Lenze, MD, Principal Investigator
Washington University School of Medicine