RecruitingPhase 2NCT07298005

Sonlicromanol in Post-COVID

SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial


Sponsor

Michele van Vugt

Enrollment

80 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria15

  • 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
  • BMI < 18.5 or > 35
  • Pregnancy or breastfeeding
  • Clinically 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 medication negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, antivirals, amiodarone and NSAIDs)
  • 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

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Interventions

DRUGSonlicromanol

Sonlicromanol 90mg twice daily for 13 weeks

DRUGPlacebo

Placebo twice daily for 13 weeks


Locations(1)

Amsterdam University Medical Center, Location Academic Medical Center (AMC)

Amsterdam, North Holland, Netherlands

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NCT07298005


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