Post COVID Condition
Conditions
Brief 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).
Interventions
DRUGSonlicromanol
Sonlicromanol 90mg twice daily for 13 weeks
DRUGPlacebo
Placebo twice daily for 13 weeks
Sponsors
Michele van Vugt
ZonMw: The Netherlands Organisation for Health Research and Development
Khondrion BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Between group differences at week 13 | Post-COVID related fatigue measured with the Fatigue Assessment Scale (FAS), a 10-item questionnaire measuring physical/mental fatigue (ranging from 10-50), with scores \<22 indicating no fatigue, 22-34 mild-to-moderate, and ≥35 severe fatigue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | Between group differences at week 13 | Muscle strength measured with the Repeated Handgrip Strength of the dominant hand |
| Cognitive function | Between group differences at week 13 | Post-COVID related cognitive function measured with the PROMIS cognitive function SF 8a, measures self-perceived cognitive abilities, with scores converted to a T-score (mean 50, SD 10), where higher scores indicate better functioning |
| Health related quality of life | Between group differences at week 13 | Health related quality of life measured with the SF-36 questionnaire with scores ranging from 0-100, where higher scores indicate better quality of life |
| Fatigue | Between group differences at week 13 | Post-COVID related fatigue measured with the NeuroQoL SF Fatigue, resulting in a T-score (mean 50, SD 10) where higher scores mean more fatigue |
Countries
Netherlands
Outcome results
None listed