Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial

NCT ID: NCT07298005

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-03-31

Brief Summary

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).

Conditions

Post COVID Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

Sonlicromanol

Intervention Type: DRUG

Sonlicromanol 90mg bid for 13 weeks

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo bid for 13 weeks

Interventions

Sonlicromanol

Sonlicromanol 90mg bid for 13 weeks

Intervention Type: DRUG

Placebo

Placebo bid for 13 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Khondrion BV

INDUSTRY

Sponsor Role: collaborator

Michele van Vugt

OTHER

Sponsor Role: lead

Responsible Party

Michele van Vugt

Prof. Dr. M. van Vugt

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2025-521866-92-01

Identifier Type: -

Identifier Source: org_study_id