Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Michele van Vugt
With
ZonMw: The Netherlands Organisation for Health Research and Development
Khondrion BV
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
