sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19 (NCT07359482) | Clinical Trial Compass
RecruitingPhase 3
sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19
Netherlands160 participantsStarted 2026-06-04
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 seru…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial testing SSRIs specifically for post-COVID fatigue — does my pattern of fatigue and other post-COVID symptoms match what this trial is designed to study, and would I actually be a good candidate to discuss with the research team?
2Since SSRIs are already approved medications for other conditions, what is my doctor's sense of the current evidence for using them to treat post-COVID fatigue, and how does joining a trial like this compare to simply trying an SSRI through standard care?
3What are the known side effects of SSRIs that I should weigh carefully before considering a trial like this, especially if I'm already dealing with post-COVID symptoms that might overlap with those side effects?
4Because this trial is actively recruiting and in Phase 3, does my doctor think the existing evidence is strong enough that participating would be reasonable, or would they recommend waiting to see the results once the trial is complete?
5How would taking part in this trial affect my day-to-day life in terms of visits, monitoring, or restrictions, and is that realistic given how my post-COVID fatigue is already affecting my ability to manage daily activities?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue severity
Timeframe: week 12
Trial details
NCT IDNCT07359482
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)