Clinical Trial

sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19

Study acronym: ESPRIT
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-06-10
notable Primary completion pushed: 2027-03-01 -> 2027-12-31 2026-06-10
Trial Details
NCT Number NCT07359482
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions Post-COVID, POST-Covid 19, Post-COVID Conditions
Enrollment 160 participants
Start Date 2026-06-04
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-09