Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT07298005
Eligibility Criteria:
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:
* Patiënts at risk for cardiac conduction disorders
* History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP
* Clinical significant respiratory or cardiovascular disease,
* Instable neurological disease
* Clinical 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 breast feeding
* Clinicaly 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 medicatin negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, anti-virals, amiodarone and NSAID's)
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07298005
Study Brief:
Protocol Section:
NCT07298005