[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615853":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":29,"responsibleParty":50,"collaborators":54,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL",null,[13],"Drug: Sonlicromanol",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo group","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Sonlicromanol","Sonlicromanol 90mg twice daily for 13 weeks",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","Placebo twice daily for 13 weeks",[15],[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Amsterdam University Medical Center, Location Academic Medical Center (AMC)","RECRUITING","Amsterdam","North Holland","1105 AZ","Netherlands","NL",{"type":39,"coordinates":40},"Point",[41,42],4.88969,52.37403,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},"Bastienne De Jonghe, MD","CONTACT","020 566 9111","postcovidtrials@amsterdamumc.nl",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Michele van Vugt","Prof. Dr. M. van Vugt",[55,57],{"name":56,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":58,"class":59},"Khondrion BV","INDUSTRY","100615853","phase-2-sonlicromanol-in-post-covid-100615853",false,"NCT07298005","Sonlicromanol in Post-COVID","SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial","SON4PEM","Inclusion Criteria:\n\n* Post COVID according to WHO criteria and verified by post COVID physician\n* Post-exertional malaise (PEM) according to DSQ-PEM questionnaire\n* Bell's disability score 20-70%\n* Mild initial SARS-CoV-2 infection (no hospitalisation)\n* WHO performance score of 0 before initial SARS-CoV-2 infection\n\nExclusion Criteria:\n\n* Patients at risk for cardiac conduction disorders\n* History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP\n* Clinically significant respiratory or cardiovascular disease\n* Unstable neurological disease\n* Clinically significant active psychiatric disorder that requires treatment\n* History of substance abuse\n* Active malignancy within the past 5 years\n* History of solid organ transplantation\n* Active HIV, hepatitis B or C infection\n* BMI \\\u003C 18.5 or \\> 35\n* Pregnancy or breastfeeding\n* Clinically relevant laboratory test value outside the reference range\n* 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)\n* 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).\n* 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","ALL","18 Years","65 Years",{"count":72,"type":73},80,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","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).",[79],"Post COVID Condition","2026-04-07",{"date":82,"type":83},"2026-04-13","ACTUAL",{"date":85,"type":73},"2026-04",{"date":87,"type":73},"2027-03",{"name":52,"class":6},1]