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

NCT07359482 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Post-COVID
  • POST-Covid 19
  • Post-COVID Conditions

Interventions

DRUG

Fluvoxamine

Subject are randomized in a double-blind manner (1:1 ratio) between fluvoxamine and placebo. During the first week subjects will receive a low dose daily dose of fluvoxamine of 25 mg or placebo. In the second week, subjects will receive a daily dose of 50 mg or placebo. From week 3 onwards, the fluvoxamine or placebo dose is increased by daily 50 mg every 6 days in a blinded manner but will not be further increased if participants are unwilling to accept a dose increase. For doses higher than 100 mg per day, dosing is done twice daily. The dose is increased to a maximum of 200 mg per day (i.e. 100 mg bid). The minimal daily dose is 50 mg.

DRUG

Placebo

Subject are randomized in a double-blind manner (1:1 ratio) between fluvoxamine and placebo. During the first week subjects will receive a low dose daily dose of fluvoxamine of 25 mg or placebo. In the second week, subjects will receive a daily dose of 50 mg or placebo. From week 3 onwards, the fluvoxamine or placebo dose is increased by daily 50 mg every 6 days in a blinded manner but will not be further increased if participants are unwilling to accept a dose increase. For doses higher than 100 mg per day, dosing is done twice daily. The dose is increased to a maximum of 200 mg per day (i.e. 100 mg bid). The minimal daily dose is 50 mg.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-03-01
Completion
2028-05-01

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07359482 on ClinicalTrials.gov