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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.
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I am unable to understand and give consent for treatment.
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I am immunocompromised due to a transplant, high dose steroids, or specific medication.
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I need to be in the hospital to start the study.
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I can perform the study procedures and do not live in Missouri or Illinois.
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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
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
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.
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.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,980 Previous Clinical Trials
2,290,980 Total Patients Enrolled
26 Trials studying COVID-19
19,598 Patients Enrolled for COVID-19
Balvi COVID FundUNKNOWN
Eric Lenze, MDPrincipal InvestigatorWashington University School of Medicine
9 Previous Clinical Trials
3,156 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication for depression or anxiety.I am unable to understand and give consent for treatment.I am 25 years old or older.I am immunocompromised due to a transplant, high dose steroids, or specific medication.I need to be in the hospital to start the study.I am not taking phenytoin, clopidogrel, or St John's wort.I've felt my thinking or memory get worse over the last 2 months, and it's not because of medication or another illness.I am not willing to reduce my alprazolam or diazepam dose by 25%.I am not taking theophylline, tizanidine, clozapine, or olanzapine regularly.I had COVID symptoms or a positive test over 3 months ago.I have bipolar disorder or am on medication for it, but my doctor thinks I'm unlikely to experience mania.I can perform the study procedures and do not live in Missouri or Illinois.I am currently taking donepezil or sertraline.You are already taking part in another study testing COVID-19 treatments, except for vaccine or prevention studies.
Research Study Groups:
This trial has the following groups:- Group 1: Fluvoxamine
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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