Fluvoxamine for Post-COVID Syndrome

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether fluvoxamine, a medication typically used for OCD, can alleviate symptoms of Long COVID. Researchers aim to determine if fluvoxamine improves lingering issues such as brain fog and fatigue after a COVID infection. Participants will receive either fluvoxamine or a placebo to compare outcomes. Individuals may qualify if they live in Missouri or Illinois, have had COVID, and continue to experience cognitive issues like difficulty concentrating. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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%.

Is there any evidence suggesting that fluvoxamine is likely to be safe for humans?

Research shows that fluvoxamine is generally safe for people. In studies related to COVID-19, it has helped prevent hospital stays. The FDA has approved fluvoxamine for treating Obsessive Compulsive Disorder (OCD), which supports its safety.

In the TOGETHER trial, researchers gave fluvoxamine to COVID-19 patients and found no major safety problems, suggesting it is safe for similar uses. Additionally, data from 651 people in other fluvoxamine studies showed no serious side effects from the treatment.

Overall, research supports that fluvoxamine is safe for treating conditions like COVID-19 and might also be safe for long COVID. However, discussing any concerns with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for post-COVID syndrome, which often focus on managing symptoms like fatigue and brain fog with supportive care and symptom-specific medications, fluvoxamine is unique because it targets inflammation. Researchers are excited about fluvoxamine because it is traditionally used as an antidepressant, but it has shown potential anti-inflammatory effects that might address the underlying causes of post-COVID symptoms. This dual action could offer a new way to tackle the condition at its root, potentially improving overall recovery for patients rather than just alleviating symptoms.

What evidence suggests that fluvoxamine might be an effective treatment for Long COVID?

Research has shown that fluvoxamine, a medication typically used for OCD, might help treat COVID-19 by preventing symptoms from worsening. Some studies, such as the STOP COVID and TOGETHER trials, suggested it could reduce the likelihood of hospitalization for COVID-19. There is also hope it might aid in treating long COVID, where symptoms persist long after the initial illness. However, not all studies agree, and some found no significant improvement in mild cases. Overall, the evidence appears promising, but more research is needed to confirm its effectiveness for long COVID. Participants in this trial will receive either fluvoxamine or a placebo to assess its effectiveness for post-COVID syndrome. ^{1 2 3 6 7}

Who Is on the Research Team?

Eric Lenze, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10029802/

Overview of the potential use of fluvoxamine for COVID-19 ... This review presents an overview of the potential of fluvoxamine in the treatment and clinical management of COVID-19 and long COVID.

2. nature.com nature.com/articles/s41598-024-64260-9

A systematic review and meta-analysis, investigating dose ... The results of this study identified fluvoxamine as effective in preventing clinical deterioration, and subgrouping analysis suggests that earlier treatment ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05874037

NCT05874037 | Fluvoxamine for Long COVID-19 This trial is testing whether fluoxamine helps to improve symptoms and the negative impacts of long COVID in residents of Missouri and Illinois. Detailed ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1876034123003374

The real-world effectiveness of fluvoxamine therapy in mild ... Fluvoxamine treatment is failed to demonstrate effectiveness in preventing deterioration in mild to moderate COVID-19 and may lead to a higher incidence of ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2812204

Higher-Dose Fluvoxamine and Time to Sustained ... Fluvoxamine, 100 mg twice daily, does not shorten the duration of symptoms in outpatient adults with mild to moderate COVID-19.

6. thelancet.com thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext

Effect of early treatment with fluvoxamine on risk ... Recent evidence indicates a potential therapeutic role of fluvoxamine for COVID-19. In the TOGETHER trial for acutely symptomatic patients with COVID-19, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12231207/

Results From Studies of Fluvoxamine for COVID‐19 Treatment We analyzed data from 651 participants in two clinical trials of fluvoxamine for COVID‐19 treatment. Daily assessments of pulse, blood pressure, ...