Fluvoxamine for Long COVID-19 (NCT05874037) | Clinical Trial Compass
CompletedPhase 2/3
Fluvoxamine for Long COVID-19
United States191 participantsStarted 2023-05-15
Plain-language summary
This clinical trial aims to test the effects of fluvoxamine as a treatment for Long COVID. Fluvoxamine is an FDA approved SSRI for Obsessive Compulsive Disorder (OCD), that has already had success in preventing hospitalization in patients with COVID-19 (STOP COVID and TOGETHER trials). This trial is testing whether fluoxamine helps to improve symptoms and the negative impacts of long COVID in residents of Missouri and Illinois.
Who can participate
Age range
25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men and woman age 25 and older;
. Not currently hospitalized
. Participant self-report of past acute COVID episode with symptom onset and/or initial positive test at least 3 months since initial COVID symptoms and/or test confirming SARS-CoV-2 infection Note: Since some people with long COVID may not have been able to obtain testing during the acute phase of illness, history of a positive COVID-19 test is not required. We will collect data regarding the results of any past COVID-19 testing, but this will not affect eligibility for the trial.
. Currently symptomatic with self-reported worsening of cognitive function for at least the past 2 months, that could not be better explained by other reasons (i.e. alternative diagnosis or medication changes).
. Able to provide informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Total Symptom Scores
Timeframe: Assessed at Baseline (2 weeks prior to randomization) and Endpoint (last 4 weeks of randomized period)
. Illness severe enough to require hospitalization at the time of starting the study.
. 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, including not being a resident of the states of Missouri or Illinois
. Taking donepezil (rationale: donepezil is a S1R agonist), or sertraline (rationale: sertraline is a strong sigma-1 antagonist).
. Taking 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)