Fluvoxamine as a Treatment for Long COVID-19: A Randomized Placebo Controlled Trial

Plain English Summary

Fluvoxamine for Long COVID-19 is a Phase 3 clinical trial sponsored by Washington University School of Medicine studying Long COVID. This trial tests if the drug fluvoxamine can help improve symptoms in people with Long COVID. It is for adults aged 25 and older who live in Missouri or Illinois and have had Long COVID symptoms for at least 3 months. Participants will take either fluvoxamine or a placebo (a dummy pill) for about 18 weeks. Alternative treatments for Long COVID are still being researched, and this trial explores a new option. The trial aims to enroll 191 participants.

Official Summary

This clinical trial aims to test the effects of fluvoxamine as a treatment for Long COVID. Fluvoxamine is an FDA approved SSRI for Obsessive Compulsive Disorder (OCD), that has already had success in preventing hospitalization in patients with COVID-19 (STOP COVID and TOGETHER trials). This trial is testing whether fluoxamine helps to improve symptoms and the negative impacts of long COVID in residents of Missouri and Illinois.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 25 or older, not currently hospitalized, and have had Long COVID symptoms for at least 3 months. You must be experiencing worsening cognitive function (like brain fog) for at least 2 months. You cannot join if you have severe illness requiring hospitalization, unstable medical conditions, are immunocompromised, or are already in another COVID-19 drug trial. Certain medications, including other SSRIs/SNRIs, or specific drugs like donepezil, sertraline, phenytoin, clopidogrel, St. John's wort, or medications for bipolar disorder, may exclude you. This trial is studying Long COVID, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how much participants' symptom scores improve over approximately 18 weeks, indicating the drug's potential to alleviate Long COVID discomfort. The specific primary outcome measures are: Total of symptom score via the daily questionnaire (Approximately 18 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses the significant unmet need for effective treatments for Long COVID, a condition affecting many individuals after initial infection. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Long COVID, where improved treatment options are needed.

Investor Insight

This trial investigates an existing, FDA-approved drug for a new indication, potentially offering a faster path to market if successful, given the large and growing Long COVID patient population. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if fluvoxamine is appropriate for you, considering your health history and other medications. Participation involves taking study medication daily for about 18 weeks and completing symptom questionnaires. You will need to attend study visits and may undergo medical assessments as part of the trial. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 191 participants

Interventions

• DRUG: Fluvoxamine — Fluvoxamine is an FDA approved drug for the treatment of OCD. This trial is testing the effects of the drug on long COVID.

Primary Outcomes

• Total of symptom score via the daily questionnaire (Approximately 18 weeks)

Full Eligibility Criteria

Inclusion Criteria:

1. Men and woman age 25 and older;
2. Not currently hospitalized
3. Participant self-report of past acute COVID episode with symptom onset and/or initial positive test at least 3 months since initial COVID symptoms and/or test confirming SARS-CoV-2 infection Note: Since some people with long COVID may not have been able to obtain testing during the acute phase of illness, history of a positive COVID-19 test is not required. We will collect data regarding the results of any past COVID-19 testing, but this will not affect eligibility for the trial.
4. Currently symptomatic with self-reported worsening of cognitive function for at least the past 2 months, that could not be better explained by other reasons (i.e. alternative diagnosis or medication changes).
5. Able to provide informed consent.
6. Currently reside in Missouri or Illinois

Exclusion Criteria:

1. Illness severe enough to require hospitalization at the time of starting the study.
2. Unstable medical comorbidities (eg decompensated cirrhosis), per patient report and/or medical records.
3. Immunocompromised from the following: solid organ transplant, BMT, high dose steroids (\>20mg prednisone per day), or tocilizumab
4. Already enrolled in another COVID 19 medication trial (not including vaccination or prophylaxis trials)
5. Unable to provide informed consent
6. Unable to perform the study procedures, including not being a resident of the states of Missouri or Illinois
7. Taking donepezil (rationale: donepezil is a S1R agonist), or sertraline (rationale: sertraline is a strong sigma-1 antagonist).
8. Taking phenytoin (rationale: fluvoxamine inhibits its metabolism), clopidogrel (rationale: fluvoxamine inhibits its metabolism from pro-drug to active drug which raises risk of cardiovascular events), and St John's wort (rationale: fluvoxamine + St John's wort are considered contraindicated because of the risk of serotonin syndrome)
9. Taking SSRIs or SNRIs.
10. Individuals who report they have bipolar disorder or are taking medication for bipolar disorder (lithium, valproate, high-dose antipsychotic), unless the investigator concludes that the risk for mania is unlikely (ie it is doubtful that the patient actually has bipolar disorder).
11. Individuals who take alprazolam or diazepam and are unwilling to cut the medication by 25% (rationale: fluvoxamine modestly inhibits the metabolism of these drugs).
12. Participants taking theophylline, tizanidine, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by CYP 1A2, which is inhibited by fluvoxamine) will be reviewed with a study investigator and excluded unless the investigator concludes that the risk to the participant is low (this would be unlikely; example: participant takes tizanidine only as needed and is willing to avoid it during study duration).

Trial Locations

• Washington University School of Medicine, St Louis, Missouri, United States

Frequently Asked Questions

Related Conditions

• Long COVID
• Post-viral syndromes
• Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
• Fibromyalgia
• Cognitive dysfunction
• Neurological disorders
• Autoimmune diseases
• Respiratory conditions
• Cardiovascular conditions
• Mental health conditions

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