Fluvoxamine for post-COVID fatigue and cognitive symptoms
Official title: sElective Serotonin reuPtake inhibitoRs In posT-covid: ESPRIT
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT07359482 · Data updated 2026-11-12
This study tests whether fluvoxamine can help reduce fatigue and brain-related symptoms after COVID-19 compared with a placebo in adults with long-COVID.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam-Zuidoost) |
| Status | Recruiting |
| Started | June 4, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | May 1, 2028 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07359482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-70 with severe fatigue persisting for at least 3 months after confirmed COVID-19 and meeting onset criteria.
✕Probably not a fit
Individuals without fatigue or whose symptoms do not improve with fluvoxamine may not experience benefit and could have treatment-related risks.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, placebo-controlled Phase 3 trial will enroll 160 adults with post-COVID fatigue and related symptoms to test if fluvoxamine, dosed from 50 mg to 200 mg daily for 12 weeks, can lessen fatigue severity and related issues such as cognitive problems, PEM, and POTS. The study will monitor changes in plasma biomarkers (inflammatory markers, cortisol, serotonin, IDO-2 activity, kynurenine pathway) and, in an optional neuroimaging sub-study, brain function during cognitive tasks. Primary outcome is fatigue severity after 12 weeks; secondary outcomes include cognition, PEM, POTS, and quality of life, with exploratory analyses linking symptom changes to biomarker shifts. The trial will compare fluvoxamine to placebo, with adult post-COVID patients recruited from Amsterdam UMC, to understand potential mechanisms and therapeutic benefit.
Why it matters
Potential benefit: If successful, participants may experience reduced fatigue and improved cognitive function and daily living after COVID-19.
How similar studies have gone: Prior observational and early studies in similar post-viral fatigue settings have shown signals of neural and inflammatory changes; this interventional trial tests the approach in a controlled setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 70 years * Severely fatigued (CIS fatigue score ≥ 35) at screening * Fatigue started/increased significantly after Covid-19 (self-declared) * Fatigue symptoms must be present for at least 3 months following the acute infection. * Self-reported confirmation of having a SARS-CoV-2 infection by: Positive SARS-CoV-2 nucleic acid amplification test (NAAT), such as PCR; Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests; COVID-19 diagnosis by a medical specialist (GP or in-hospital), based on the above or other clinical test or assessments. The above information will not be verified in medical records. * Command of Dutch or English language to complete questionnaires * Able to participate in video calling. * Willing and able to provide informed consent * Allowing the trial team to exchange medical information that is relevant for the participants' safety and trial assessments with their GP and pharmacy. Exclusion Criteria: * Use of medication with interaction with fluvoxamine that cannot be discontinued * Hospitalized in the acute phase of Covid-19 * Psychiatric/somatic disorders that could explain the severity of fatigue * Neurodegenerative disorders (i.e. M Parkinson, Multiple sclerosis, M Alzheimer) * Suicidality (current or recent) (according to WHO suicide screener) * Starting or started with other medication intended to reduce post-covid symptoms during the last 2 months * Pregnancy (a positive urine or serum pregnancy test) or unwilling to use standard contraception * Brugada- or Long QT interval syndrome * epilepsy, porphyria, history of severe liver impairment * known allergies to fluvoxamine or placebo/excipients * known current alcohol or drug use problems. * Bleeding disorders and past medical history of bleeding gastric or duodenal ulcers or other significant bleeding disorders * claustrophobia (optional MRI substudy) * having metal implants (optional MRI substudy) * inability to lay still for 45 minutes (optional MRI substudy) * Neurotrauma/ large stroke or brain abnormalities interfering with image analyses (optional MRI substudy) * Inability to come to the Amsterdam UMC (optional MRI substudy).
Where it's running
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Amsterdam UMC
Amsterdam-Zuidoost, Netherlands Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.