NCT07359482 sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19
| NCT ID | NCT07359482 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Post-COVID |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2026-06-04 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Fatigue, cognitive problems, post-exertional malaise (PEM) and postural orthostatic tachycardia syndrome (POTS) are common and debilitating symptoms after COVID-19. The pathophysiology of post-COVID is not well understood and there is no established biomedical treatment. Treatment options for post-COVID are thus much needed. A promising candidate intervention is fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), that may reduce post-COVID symptoms because of its regulatory effect on the (neuro) immune system, the hypothalamic-pituitary-adrenal (HPA) axis and the tryptophan system. The investigators will randomize 160 participants to either fluvoxamine or placebo for 12 weeks. The investigators will use advanced functional neuroimaging techniques during cognitive challenge (optional substudy) and plasma biomarkers (inflammatory markers, cortisol, serotonin, IDO-2 activity), to facilitate identifying potential mechanistic pathways of post -COVID treatment.
Eligibility 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).
Frequently Asked Questions
Who can join the NCT07359482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Post-COVID. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07359482 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT07359482 currently recruiting?
Yes, NCT07359482 is actively recruiting participants. Visit ClinicalTrials.gov or contact Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) to inquire about joining.
Where is the NCT07359482 trial being conducted?
This trial is being conducted at Amsterdam-Zuidoost, Netherlands.
Who is sponsoring the NCT07359482 clinical trial?
NCT07359482 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 160 participants.
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