Tests fluvoxamine against a placebo for long-lasting symptoms after COVID-19
Tests fluvoxamine, or a placebo, in adults with symptoms lasting after COVID-19.
Plain-language title generated from the registry record
Registry title: sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19
Key facts
- Where
- Amsterdam-Zuidoost, NetherlandsSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07359482, who can take part
Where in Netherlands
- Amsterdam UMCAmsterdam-Zuidoost, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Trial code
- NCT07359482
- Record updated
- 9 June 2026
- Original description
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.Read full original descriptionShow less
sElective Serotonin reuPtake inhibitoRs In posT-covid: ESPRIT
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.
Inclusion: 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: Use of medication with interaction with fluvoxamine that cannot be discontinued; known current alcohol or drug use problems; having metal implants (optional MRI substudy); 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); Starting or started with other medication intended to reduce post-covid symptoms during the last 2 months; epilepsy, porphyria, history of severe liver impairment; known allergies to fluvoxamine or placebo/excipients; Bleeding disorders and past medical history of bleeding gastric or duodenal ulcers or other significant bleeding disorders; Neurotrauma/ large stroke or brain abnormalities interfering with image analyses (optional MRI substudy); Pregnancy (a positive urine or serum pregnancy test) or unwilling to use standard contraception; Brugada- or Long QT interval syndrome; Suicidality (current or recent) (according to WHO suicide screener); claustrophobia (optional MRI substudy); inability to lay still for 45 minutes (optional MRI substudy); Inability to come to the Amsterdam UMC (optional MRI substudy).