ESPRIT study

Prior treatment

• Use of medication with interaction with fluvoxamine that cannot be discontinued

Other illness

• 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

Lab values

• 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

Other

• Suicidality (current or recent) (according to validated WHO suicide screener)

• 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.