Sonlicromanol in Post-COVID
The aim of this randomized, double-blind, placebo-controlled, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM).
| Condition(s) | Post COVID Condition |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The aim of this randomized, double-blind, placebo-controlled, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM). |
| Who can participate | Inclusion Criteria: * Post COVID according to WHO criteria and verified by post COVID physician * Post-exertional malaise (PEM) according to DSQ-PEM questionnaire * Bell's disability score 20-70% * Mild initial SARS-CoV-2 infection (no hospitalisation) * WHO performance score of 0 before initial SARS-CoV-2 infection Exclusion Criteria: * Patients at risk for cardiac conduction disorders * History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP * Clinically significant respiratory or cardiovascular disease * Unstable neurological disease * Clinically significant active psychiatric disorder that requires treatment * History of substance abuse * Active malignancy within the past 5 years * History of solid organ transplantation * Active H |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Michele van Vugt |
| Locations | Amsterdam, North Holland, Netherlands |
| Start date | 2026-04 |
| NCT ID | NCT07298005 |
| Official listing | https://clinicaltrials.gov/study/NCT07298005 |