Sonlicromanol in Post-COVID

Korábbi kezelés

• 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)

Más betegség

• 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).

Laborértékek

• 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

Egyéb

• BMI < 18.5 or > 35
• Pregnancy or breastfeeding

• 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