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Recruiting NCT07298005

Sonlicromanol in Post-COVID

Phase II Interventional Post COVID Condition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sonlicromanol, Placebo.
Who it may be relevant to
Registry conditions: Post COVID Condition. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug Sonlicromanol
    Sonlicromanol 90mg twice daily for 13 weeks
  • Drug Placebo
    Placebo twice daily for 13 weeks

Primary outcome measures

  • Fatigue [Time frame: Between group differences at week 13]
Secondary outcome measures (4)
  • Muscle strength [Time frame: Between group differences at week 13]
  • Cognitive function [Time frame: Between group differences at week 13]
  • Health related quality of life [Time frame: Between group differences at week 13]
  • Fatigue [Time frame: Between group differences at week 13]

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Amsterdam University Medical Center, Location Academic Medical Center (AMC) — Amsterdam

Identifiers

NCT: NCT07298005 · 2025-521866-92-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗