Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT07298005

Sonlicromanol in Post-COVID

Led by Michele van Vugt · Updated on 2026-04-13

80

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

Sponsors

M

Michele van Vugt

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Sonlicromanol in Post-COVID

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients at risk for cardiac conduction disorders
  • History of clinical significant gastro-intestinal surgery or dysmotility that impairs the absorption 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 certain medications unless stable for at least one month before and during the study, including (multi)vitamins, co-enzyme Q10, Vitamin E, riboflavin, amino acids, antioxidant supplements, and medications negatively influencing mitochondrial functioning
  • Use of medications that are moderate or strong CYP3A4 inhibitors, inducers, substrates with narrow therapeutic index, or strong P-glycoprotein inhibitors
  • Use of any medication known to affect cardiac repolarization unless QTc interval at screening is normal during stable treatment for two weeks or 5 half-lives

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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