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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 18 weeks
Awards & highlights
Study Summary
This trial tests if a common OCD drug can improve long COVID symptoms & reduce their impacts.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 18 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with improvement of long COVID symptoms
Side effects data
From 2021 Phase 3 trial • 670 Patients • NCT046689506%
Nausea/vomitting
2%
Pneumonia
1%
Breathing problems
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluvoxamine
Placebo
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
~3259230
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,402 Total Patients Enrolled
26 Trials studying COVID-19
20,233 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial still actively inviting participants?
"Affirmative. Clinicaltrials.gov has information that proves recruitment for this medical trial is in full swing, with the initial post date on May 15th 2023 and an update made lastly on May 22nd 2023. The study requires 300 patients to be enrolled from one centre of operations."
Answered by AI
What is the exact size of the participant pool for this research endeavor?
"Affirmative. This medical study, which was first made available on May 15th 2023, is actively recruiting patients as per information found on clinicaltrials.gov. To reach completion of the trial, 300 individuals are expected to participate from a single site."
Answered by AI
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