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NCT Number: NCT07298005

Sonlicromanol in Post-COVID

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Amsterdam, North Holland, 1105 AZ, Netherlands

Location status: Recruiting

Location contact

Bastienne De Jonghe, MD

CONTACT

[email protected]

020 566 9111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Sonlicromanol

Drug

Sonlicromanol 90mg twice daily for 13 weeks

Placebo

Drug

Placebo twice daily for 13 weeks

Primary outcomes

  1. Fatigue

    Time frame: Between group differences at week 13

    Post-COVID related fatigue measured with the Fatigue Assessment Scale (FAS), a 10-item questionnaire measuring physical/mental fatigue (ranging from 10-50), with scores <22 indicating no fatigue, 22-34 mild-to-moderate, and ≥35 severe fatigue

Secondary outcomes

  1. Muscle strength

    Time frame: Between group differences at week 13

    Muscle strength measured with the Repeated Handgrip Strength of the dominant hand

  2. Cognitive function

    Time frame: Between group differences at week 13

    Post-COVID related cognitive function measured with the PROMIS cognitive function SF 8a, measures self-perceived cognitive abilities, with scores converted to a T-score (mean 50, SD 10), where higher scores indicate better functioning

  3. Health related quality of life

    Time frame: Between group differences at week 13

    Health related quality of life measured with the SF-36 questionnaire with scores ranging from 0-100, where higher scores indicate better quality of life

  4. Fatigue

    Time frame: Between group differences at week 13

    Post-COVID related fatigue measured with the NeuroQoL SF Fatigue, resulting in a T-score (mean 50, SD 10) where higher scores mean more fatigue

Sponsors and collaborators

Lead sponsor

Michele van Vugt

Other

Collaborators

  • Khondrion BV
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: SON4PEM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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