Sonlicromanol for Fatigue in People With Post-COVID Condition
Tests sonlicromanol against placebo for fatigue in adults with post-COVID and post-exertional malaise.
Plain-language title generated from the registry record
Registry title: Sonlicromanol in Post-COVID
Key facts
- Where
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07298005, who can take part
Where in Netherlands
- Amsterdam University Medical Center, Location Academic Medical Center (AMC)Amsterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Michele van Vugt
- Trial code
- NCT07298005
- Record updated
- 18 August 2026
- Original description
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).Read full original descriptionShow less
SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial
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).
Inclusion: 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: Use of the following medication, unless stable for at least one month before study and remaining stable throughout the study: (multi)vitamins, co-enzyme Q10, Vitamin E, riboflavin, amino acids, antioxidant supplements and any medication negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, antivirals, amiodarone and NSAIDs); 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 HIV, hepatitis B or C infection; Use of the following medication: any moderate or strong Cytochrome P450 (CYP)3A4 inhibitors (all 'conazoles-anti-fungals', HIV antivirals, grapefruit), strong CYP3A4 inducers ((including HIV antivirals, carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort, pioglitazone, troglitazone) or any medication metabolized by CYP3A4 with a narrow therapeutic index, medication known to be substrate of Organic Cation Transporter 1 (OCT1) and organic cation transporter 2 (OCT2) or strong P-glycoprotein inhibitors (including amiodarone, azithromycin, captopril, clarithromycin, cyclosporine, piperine, quercetin, quinidine, quinine, reserpine, ritonavir, tariquidar, and verapamil); Clinically relevant laboratory test value outside the reference range; Use of any medication known to affect cardiac repolarization unless QTc interval at screening is normal during stable treatment for a period of two weeks, or 5 half-lives; BMI < 18.5 or > 35; Pregnancy or breastfeeding.