ESPRIT study
Key facts
- Where
- Amsterdam, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Amsterdam UMC Research B.V.Amsterdam, HollandiaTaking 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
- Amsterdam UMC Stichting
- Trial code
- EU 2024-519540-32-00
- Record updated
- 2026. április 8.
- Original description
To determine if fluvoxamine treatment (50 mg to 200 mg daily dosing) results in lower levels of fatigue severity than placebo after 12 weeks of treatment.Read full original descriptionShow less
sElective Serotonin reuPtake inhibitoRs In posT-covid: ESPRIT
To determine if fluvoxamine treatment (50 mg to 200 mg daily dosing) results in lower levels of fatigue severity than placebo after 12 weeks of 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); 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; 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 general practitioner and pharmacy.
Exclusion: 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); Starting or started with other medication intended to reduce post-covid symptoms during the last 2 months; epilepsy, porphyria, history of severe liver impairment; Pregnancy (a positive urine or serum pregnancy test)/ unwilling to use standard contraception; Brugada- or Long QT interval syndrome; Clinical laboratory test results at the baseline visit requiring immediate medical attention (refer to Appendix 6 and 7); 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; Additional exclusion criteria optional neuro-imaging sub-study: claustrophobia; Additional exclusion criteria optional neuro-imaging sub-study: having metal implants; Additional exclusion criteria optional neuro-imaging sub-study: inability to lay still for 45 minutes; Additional exclusion criteria optional neuro-imaging sub-study: Neurotrauma/ large stroke or brain abnormalities interfering with image analyses; Additional exclusion criteria optional neuro-imaging sub-study: Inability to come to the Amsterdam UMC; Suicidality (current or recent) (according to validated WHO suicide screener).