Long COVIDPhase 2/3NCT05874037
Fluvoxamine for Long COVID-19
A Phase 2/3 study testing Fluvoxamine in people with Long COVID, run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- Fluvoxamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 15 Mar 2025
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and woman age 25 and older;
- Not currently hospitalized
- 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.
- 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).
- Able to provide informed consent.
- Currently reside in Missouri or Illinois
Who cannot join
- Illness severe enough to require hospitalization at the time of starting the study.
- Unstable medical comorbidities (eg decompensated cirrhosis), per patient report and/or medical records.
- Immunocompromised from the following: solid organ transplant, BMT, high dose steroids (>20mg prednisone per day), or tocilizumab
- Already enrolled in another COVID 19 medication trial (not including vaccination or prophylaxis trials)
- Unable to provide informed consent
- Unable to perform the study procedures, including not being a resident of the states of Missouri or Illinois
Show all 12Show fewer
- Taking donepezil (rationale: donepezil is a S1R agonist), or sertraline (rationale: sertraline is a strong sigma-1 antagonist).
- 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)
- Taking SSRIs or SNRIs.
- 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).
- Individuals who take alprazolam or diazepam and are unwilling to cut the medication by 25% (rationale: fluvoxamine modestly inhibits the metabolism of these drugs).
- 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 and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Fluvoxamine as a Treatment for Long COVID-19: A Randomized Placebo Controlled Trial
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.
Read the detailed description
This clinical trial will test a promising drug for treatment of long COVID in 300 adults who 1) are post-COVID-19 (at least 3 months since initial COVID symptoms and/or test confirming SARS-CoV-2 infection); and 2) have evidence of neurocognitive Long COVID (e.g., "brain fog", trouble concentrating, etc) which is causing suffering and/or impairment. The trial will determine whether fluvoxamine (1) reduces long COVID symptoms, 2) improves cognitive performance. Fluvoxamine is an SSRI (FDA approved for OCD) that also activates the sigma-1 receptor (an immunomodulatory receptor). It has been shown to prevent clinical deterioration and hospitalization in outpatients with acute COVID-19 (STOP COVID and TOGETHER trials). For the current study, we will randomize participants to fluvoxamine which is initially dosed at their preference, vs. placebo. This is done in the following manner. First, each participant will receive an acute bout of fluvoxamine: one dose of 25mg, then one dose of 50mg, then one dose of 100mg. We will assess their subjective reaction to these test doses and use the information to randomize them to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks. The benefits of this are (1) participants are more likely to accept randomization and continue in the study if randomized to a dose they've already tested and accepted; (2) participants' initial response, if any, to the acute dose may allow future precision-medicine use of fluvoxamine, allowing physicians to give patients a test dose and then a full trial preferentially to participants who are likely to respond. No symptom data is recorded during this test dose phase. Participants then enter a two-week Lead-In where they report symptoms twice daily via EMA surveys, and once daily remote cognitive tests. Participants are then randomized to a 16 weeks of fluvoxamine or placebo and complete twice-daily surveys. After the randomized portion of the trial, participants will be given an opportunity to try an open-label treatment with fluvoxamine for up to 16 weeks. No symptom data is collected during this open-label phase. At the end of treatment, the study medication will be tapered off over an approximate 1-2 week period, depending on the final dose of study medication, and adjusted as appropriate if they experience discontinuation symptoms. Outcome assessments will be a combination of patient-reported assessments and validated neuropsychological tests.
- Conditions
- Long COVID
- Being tested
- Fluvoxamine
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvoxamineDrug
Fluvoxamine is an FDA approved drug for the treatment of OCD. This trial is testing the effects of the drug on long COVID.
| Study group | Role | What they receive |
|---|---|---|
| Fluvoxamine | Experimental | Not described Receives: Drug: Fluvoxamine |
| Placebo | Placebo comparator | Not described Receives: Drug: Fluvoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Symptom Scores
Participants completed a self-report twice-daily questionnaire which asks about trouble concentrating, anxiety, depression and fatigue. Respondents rate how much of a problem the symptom is "right now" on a scale of 0 (no problem) to 100 (severe problem). Results compare the change in average total scores (of the four symptoms) from baseline and endpoint.
Measured: Assessed at Baseline (2 weeks prior to randomization) and Endpoint (last 4 weeks of randomized period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start15 May 2023
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Balvi COVID Fund, BJH Townley Fund
- Responsible party
- Sponsor
- Investigators
- Eric Lenze, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874037
- Sponsor's protocol ID
- 202211024
- Status last verified
- Jun 2026
- First submitted
- 22 May 2023
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluvoxamine as a Treatment for Long COVID-19: A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT05874037
- Acronym / sponsor ID
- 202211024
- Conditions
- Long COVID
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Balvi COVID Fund, BJH Townley Fund
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Posted 25 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial will test a promising drug for treatment of long COVID in 300 adults who 1) are post-COVID-19 (at least 3 months since initial COVID symptoms and/or test confirming SARS-CoV-2 infection); and 2) have evidence of neurocognitive Long COVID (e.g., "brain fog", trouble concentrating, etc) which is causing suffering and/or impairment. The trial will determine whether fluvoxamine (1) reduces long COVID symptoms, 2) improves cognitive performance. Fluvoxamine is an SSRI (FDA approved for OCD) that also activates the sigma-1 receptor (an immunomodulatory receptor). It has been shown to prevent clinical deterioration and hospitalization in outpatients with acute COVID-19 (STOP COVID and TOGETHER trials). For the current study, we will randomize participants to fluvoxamine which is initially dosed at their preference, vs. placebo. This is done in the following manner. First, each participant will receive an acute bout of fluvoxamine: one dose of 25mg, then one dose of 50mg, then one dose of 100mg. We will assess their subjective reaction to these test doses and use the information to randomize them to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks. The benefits of this are (1) participants are more likely to accept randomization and continue in the study if randomized to a dose they've already tested and accepted; (2) participants' initial response, if any, to the acute dose may allow future precision-medicine use of fluvoxamine, allowing physicians to give patients a test dose and then a full trial preferentially to participants who are likely to respond. No symptom data is recorded during this test dose phase. Participants then enter a two-week Lead-In where they report symptoms twice daily via EMA surveys, and once daily remote cognitive tests. Participants are then randomized to a 16 weeks of fluvoxamine or placebo and complete twice-daily surveys. After the randomized portion of the trial, participants will be given an opportunity to try an open-label treatment with fluvoxamine for up to 16 weeks. No symptom data is collected during this open-label phase. At the end of treatment, the study medication will be tapered off over an approximate 1-2 week period, depending on the final dose of study medication, and adjusted as appropriate if they experience discontinuation symptoms. Outcome assessments will be a combination of patient-reported assessments and validated neuropsychological tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluvoxamine | Experimental | Drug: Fluvoxamine |
| Placebo | Placebo comparator | Drug: Fluvoxamine |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and woman age 25 and older;
- Not currently hospitalized
- 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.
- 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).
- Able to provide informed consent.
Key exclusion criteria (12 listed)
- Illness severe enough to require hospitalization at the time of starting the study.
- Unstable medical comorbidities (eg decompensated cirrhosis), per patient report and/or medical records.
- Immunocompromised from the following: solid organ transplant, BMT, high dose steroids (>20mg prednisone per day), or tocilizumab
- Already enrolled in another COVID 19 medication trial (not including vaccination or prophylaxis trials)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluvoxamineFluvoxamine is an FDA approved drug for the treatment of OCD. This trial is testing the effects of the drug on long COVID. | Drug | Fluvoxamine, Placebo |
Primary outcome
Change in Total Symptom Scores
Time frame: Assessed at Baseline (2 weeks prior to randomization) and Endpoint (last 4 weeks of randomized period)
Participants completed a self-report twice-daily questionnaire which asks about trouble concentrating, anxiety, depression and fatigue. Respondents rate how much of a problem the symptom is "right now" on a scale of 0 (no problem) to 100 (severe problem). Results compare the change in average total scores (of the four symptoms) from baseline and endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
RecruitingPhase 2
DAOIB for the Treatment of Brain Fog
Long COVID
Active, not recruitingObservational study
Pain in Long COVID-19: The Role of Sleep
Long COVID
Recruiting
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Long COVID, Post COVID-19 Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Lenze, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fluvoxamine in people with Long COVID, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Symptom Scores (time frame: Assessed at Baseline (2 weeks prior to randomization) and Endpoint (last 4 weeks of randomized period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.