Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT07298005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'Between group differences at week 13', 'description': 'Post-COVID related fatigue measured with the Fatigue Assessment Scale'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'Between group differences at week 13', 'description': 'Muscle strength measured with the Repeated Handgrip Strength of the dominant hand'}, {'measure': 'Cognitive function', 'timeFrame': 'Between group differences at week 13', 'description': 'Post-COVID related cognitive function measured with the PROMIS cognitive function SF 8a'}, {'measure': 'Health related quality of life', 'timeFrame': 'Between group differences at week 13', 'description': 'Health related quality of life measured with the SF-36 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post COVID Condition']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized, doube-blind, placebo-controlled, phase II trial, is to study the effect of sonlicromanol on fatigue in patiënt with post-COVID who experience post-exertional malaise (PEM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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* Patiënts at risk for cardiac conduction disorders\n* History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP\n* Clinical significant respiratory or cardiovascular disease,\n* Instable neurological disease\n* Clinical 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 \\< 18.5 or \\> 35\n* Pregnancy or breast feeding\n* Clinicaly 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 medicatin negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, anti-virals, amiodarone and NSAID's)\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"}, 'identificationModule': {'nctId': 'NCT07298005', 'acronym': 'SON4PEM', 'briefTitle': 'Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial', 'orgStudyIdInfo': {'id': '2025-521866-92-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Drug: Sonlicromanol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sonlicromanol', 'type': 'DRUG', 'description': 'Sonlicromanol 90mg bid for 13 weeks', 'armGroupLabels': ['Intervention group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo bid for 13 weeks', 'armGroupLabels': ['Placebo group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michele van Vugt', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}, {'name': 'Khondrion BV', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. M. van Vugt', 'investigatorFullName': 'Michele van Vugt', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}