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

Study acronym: ESPRIT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Mar 1, 2027 to Dec 31, 2027 Recruitment opened · Start date changed from estimate of Mar 1, 2026 to Jun 4, 2026 · Site details revisedv3 Show 3 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Mar 1, 2026 to Jun 4, 2026
    • Site details revised
  2. Secondary endpoints: details revised at 9 of 13 entries Study description expanded, about 3 words · Study title expanded, about 2 wordsv2 Show 2 more changesShow less
    • Study description expanded, about 3 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov