Fluvoxamine for Post-COVID Syndrome

Overseen By Angela Stevens

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Washington University School of Medicine

Must not be taking: SSRIs, SNRIs, Donepezil, Sertraline

Disqualifiers: Hospitalization, Unstable comorbidities, Immunocompromised, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

191 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. If you are taking donepezil, sertraline, phenytoin, clopidogrel, St John's wort, SSRIs, SNRIs, or certain medications for bipolar disorder, you cannot participate. If you take alprazolam or diazepam, you must reduce the dose by 25%.

What data supports the effectiveness of the drug fluvoxamine for post-COVID syndrome?

Fluvoxamine, commonly used for depression and anxiety, has shown potential in reducing inflammation, which might help with post-COVID symptoms. Some studies suggest it could prevent worsening of COVID-19 symptoms, but more research is needed to confirm its effectiveness specifically for post-COVID syndrome. ^{1 2 3 4 5}

Is fluvoxamine safe for humans?

Fluvoxamine has a well-known safety record from its use as a psychiatric medication, with extensive post-marketing surveillance showing it is generally safe and well-tolerated. Common side effects include nausea, somnolence (drowsiness), and asthenia (weakness), but serious adverse events are rare. ^{2 5 6 7 8}

How does the drug fluvoxamine differ from other treatments for post-COVID syndrome?

Fluvoxamine is unique because it is a selective serotonin reuptake inhibitor (SSRI) that also acts on the sigma-1 receptor to reduce inflammation, which may help prevent the worsening of symptoms in post-COVID syndrome. Unlike other treatments, it is a repurposed psychiatric medication with a well-known safety profile, making it an accessible and potentially effective option for managing long-term COVID-19 symptoms. ^{1 2 5 9 10}

What is the purpose of this trial?

This trial is testing whether fluvoxamine can help people with long-term COVID-19 symptoms, especially those affecting brain function. The study involves adults who had COVID-19 a while ago and are still experiencing issues like 'brain fog.' The medication works by balancing brain chemicals and supporting the immune system to reduce symptoms. Fluvoxamine has shown potential in reducing inflammation in COVID-19 patients.

Research Team

Eric Lenze, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for Missouri or Illinois residents aged 25+ who've had COVID-19 symptoms or a positive test at least 3 months ago and are experiencing cognitive issues for the past 2 months. Excluded are those with bipolar disorder on certain meds, severe illnesses, hospitalization at study start, immunocompromised status, taking specific drugs like SSRIs/SNRIs, or enrolled in another COVID-19 medication trial.

Inclusion Criteria

Able to provide informed consent

Currently reside in Missouri or Illinois

I am 25 years old or older.

Exclusion Criteria

I am currently taking medication for depression or anxiety.

I am unable to understand and give consent for treatment.

I am immunocompromised due to a transplant, high dose steroids, or specific medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Dosing

Participants receive an acute bout of fluvoxamine: one dose of 25mg, then one dose of 50mg, then one dose of 100mg to assess subjective reaction

1 week

Randomized Treatment

Participants are randomized to an individually tailored course of fluvoxamine or a matched placebo

16 weeks

Open-label Extension

Participants have the opportunity to participate in open-label treatment with fluvoxamine

16 weeks

Tapering

Study medication is tapered off over an approximate 1-2 week period, adjusted as appropriate for discontinuation symptoms

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fluvoxamine

Trial Overview The trial is examining if fluvoxamine can alleviate long-term symptoms of COVID-19. Fluvoxamine is an SSRI approved for OCD that has shown promise in reducing hospitalizations in acute COVID cases. Participants will be assessed to see if their post-COVID condition improves with this treatment.

Participant Groups

Group I: Fluvoxamine Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Balvi COVID Fund

Collaborator

Trials

1

Recruited

190+

BJH Townley Fund

Collaborator

Trials

1

Recruited

190+

Findings from Research

Fluvoxamine has a favorable safety profile based on 17 years of post-marketing surveillance involving approximately 28 million patients, showing low incidences of serious adverse effects like suicidality and sexual dysfunction.

The drug is well-tolerated, with mild withdrawal symptoms reported but no evidence of drug dependence, confirming its safety as a treatment for depression and obsessive-compulsive disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluvoxamine: safety profile in extensive post-marketing surveillance. Buchberger, R., Wagner, W.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of fluvoxamine on preventing neuropsychiatric symptoms of post COVID syndrome in mild to moderate patients, a randomized placebo-controlled double-blind clinical trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Overview of the potential use of fluvoxamine for COVID-19 and long COVID. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of fluvoxamine in COVID-19 ICU patients: An open label, prospective cohort trial with matched controls. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Trial Sequential Analysis and Updated Meta-Analysis of Fluvoxamine on Clinical Deterioration in Adult Patients with Symptomatic COVID-19 Infection. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Fluvoxamine for the Early Treatment of SARS-CoV-2 Infection: A Review of Current Evidence. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Fluvoxamine: safety profile in extensive post-marketing surveillance. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety database on fluvoxamine: analysis and report. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

Outpatients prescribed with fluvoxamine around the time of COVID-19 diagnosis are not at a reduced risk of subsequent hospitalization and death compared to their non-prescribed peers: population-based matched cohort study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Prospective Cohort of Fluvoxamine for Early Treatment of Coronavirus Disease 19. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Fluvoxamine: A Review of Its Mechanism of Action and Its Role in COVID-19. [2021]