The aim of this randomized, double-blind, placebo-controlled, phase II trial, is to studythe effect of sonlicromanol on fatigue in patients with post-COVID who experiencepost-exertional malaise (PEM).
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Drug: Sonlicromanol
Sonlicromanol 90mg twice daily for 13 weeks
Drug: Placebo
Placebo bid for 13 weeks
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 HIV, hepatitis B or C infection
- BMI < 18.5 or > 35
- Pregnancy or breastfeeding
- Clinically relevant laboratory test value outside the reference range
- 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)
- 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).
- 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
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