sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Fluvoxamine
- Placebo
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov