NCT05874037CompletedPhase 2/3
Fluvoxamine for Long COVID-19
Fluvoxamine as a Treatment for Long COVID-19: A Randomized Placebo Controlled Trial
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 191 (actual)
- First submitted
- 22 May 2023
- Start date
- 15 May 2023
- Primary completion date
- 15 Mar 2025
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05874037
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 191
- From 15 May 2023 to the primary completion date, 15 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immunocompromised from the following: solid organ transplant, BMT, high dose steroids (\>20mg prednisone per day), or tocilizumab
- 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 during study duration).
Other illness
- Illness severe enough to require hospitalization at the time of starting the study.
- Already enrolled in another COVID 19 medication trial (not including vaccination or prophylaxis trials)
- 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)
- 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).
Other
- Unstable medical comorbidities (eg decompensated cirrhosis), per patient report and/or medical records.
- 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 SSRIs or SNRIs.
Who the study is looking for
- 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.
- Currently reside in Missouri or Illinois
Age in the registry: 25 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.