Fluvoxamine for Long COVID-19

NCT05874037 | Completed Phase 2 FDA Drug

• 1 other identifier: 202211024
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• Total of symptom score via the daily questionnaire

  Improvement in combined total score based upon the self-report daily questionnaire which asks about trouble concentrating, anxiety, depression and fatigue. Respondents rate how much of a problem the symptom is "right now" on a scale of 0 (no problem) to 100 (severe problem).

  Approximately 18 weeks

Study Arms (2)

Fluvoxamine

EXPERIMENTAL

Drug: Fluvoxamine

Placebo

PLACEBO COMPARATOR

Drug: Fluvoxamine

Interventions

Fluvoxamine DRUG

Fluvoxamine is an FDA approved drug for the treatment of OCD. This trial is testing the effects of the drug on long COVID.

Fluvoxamine; Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Taking SSRIs or SNRIs.
• 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 during study duration).

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Balvi COVID Fund: collaborator
• BJH Townley Fund: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Study Officials

• Eric Lenze, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: May 24, 2023
• Study Start: May 15, 2023
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)