What side effects are associated with this type of intervention?

Selective Serotonin Reuptake Inhibitors (SSRIs) such as fluvoxamine, which is being studied for its effects on long COVID, are generally well tolerated but can cause side effects including jitteriness, restlessness, anxiety, agitation, headache, sexual dysfunction, gastrointestinal symptoms (diarrhea and nausea), and insomnia. These side effects are often dose-related and may subside after the first few days of treatment. Additionally, fluvoxamine has shown potential in reducing the severity of COVID-19 by inhibiting cytokine storms. Other common treatments for COVID-19, such as dexamethasone, can cause psychiatric side effects like depression, emotional lability, euphoria, insomnia, malaise, personality changes, and psychosis.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, including antiviral drugs like remdesivir, which is used to reduce recovery time in hospitalized patients. While Fluvoxamine, an SSRI, is being studied for its potential benefits in treating long COVID, it is not yet FDA-approved for this indication. Other treatments, such as monoclonal antibodies and immunomodulators, have also received FDA approval to manage COVID-19 symptoms and complications.

What other types of research exist?

Promising, novel alternatives to Fluvoxamine for COVID-19 patients in 2024 include antiviral medications such as Paxlovid (nirmatrelvir/ritonavir) and Molnupiravir, which have shown efficacy in reducing hospitalization and severe outcomes in COVID-19 patients. Additionally, monoclonal antibodies like Sotrovimab and anti-inflammatory treatments such as Baricitinib and Tocilizumab are also considered effective alternatives.

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SSRI

Fluvoxamine for Post-COVID Syndrome

Phase 2 & 3

Recruiting

Led By Eric Lenze, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Taking SSRIs or SNRIs

Unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Fluvoxamine side effects may include nausea, headaches, sleep disturbances, and sexual dysfunction. It could also potentially interact with other medications leading to increased risks such as serotonin syndrome when combined with similar drugs.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking medication for depression or anxiety.

Select...

I am unable to understand and give consent for treatment.

Select...

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

Select...

I need to be in the hospital to start the study.

Select...

I can perform the study procedures and do not live in Missouri or Illinois.

Select...

I am currently taking donepezil or sertraline.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FluvoxamineExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluvoxamine

2020

Completed Phase 4

~3259220

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Fluvoxamine, an SSRI, is being studied for its potential benefits in treating COVID-19 due to its anti-inflammatory properties. SSRIs like fluvoxamine can modulate the immune response by reducing the production of inflammatory cytokines, which are often elevated in severe COVID-19 cases. This can help prevent the cytokine storm, a hyperinflammatory condition that can lead to severe respiratory distress and organ failure. Other common treatments include antiviral agents like nirmatrelvir/ritonavir (Paxlovid), which inhibit viral replication, and corticosteroids like dexamethasone, which reduce inflammation. These treatments are crucial as they target different aspects of the disease process, helping to reduce viral load, manage inflammation, and improve overall patient outcomes.

Key summary of German national treatment guidance for hospitalized COVID-19 patients : Key pharmacologic recommendations from a national German living guideline using an Evidence to Decision Framework (last updated 17.05.2021).Evidence and the Main Adverse Effects Regarding Drug Therapies in the War Against COVID-19.