drugset / Trial / NCT07359482

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

NCT07359482

Phase 3 Recruiting 160 enrolled Academic Medical Center - University of Amsterdam
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-06-04
Primary completion
2027-12-31
Completion
2028-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluvoxamine Unknown 50 mg
Subject Fluvoxamine Unknown 200 mg

Indications