Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial (SON4PEM)
About
Status:
Ongoing
Principal investigator:
Country:
Netherlands
Study start:
2026-01
Completion (planned):
2027-02
Last update:
2026-02-05
Research types:
Clinical research
Research areas:
Nutritional and metabolic system dysfunction
Interventions:
Drugs, Not yet ATC-classified drugs, Sonlicromanol
Priv. Sector Partner:
Sponsors:
Project description
Currently, there are no proven treatments for patients with post-COVID syndrome (PCS). Previous research has shown that mitochondria may be impaired in patients with PCS, as is also seen in mitochondrial diseases. Sonlicromanol is a drug that can improve the function of mitochondria. In patients with mitochondrial disease, sonlicromanol has previously been shown to work effectively and safely for complaints such as persistent fatigue and muscle pain.
The purpose of this study is to investigate whether the drug is sonlicromanol effective in reducing the complaints of fatigue after exercise, or post-exertional malaise (PEM), muscle pain and persistent fatigue in adults with PCS.
In this study, participants with PCS are divided into two groups. One group is given the drug sonlicromanol and the other group is given a placebo that appears identical. After 13 weeks, a questionnaire will be used to determine whether fatigue has improved. The two groups are compared at the end to see if the group with the drug sonlicromanol has improved more strongly than the group with the placebo.
For this study, the Amsterdam UMC will collaborate with the Vrije Universiteit Amsterdam and the pharmaceutical company Khondrion, which produces the drug sonlicromanol. Khondrion has conducted multiple studies with this drug and has a lot of experience in the field of mitochondrial diseases. Furthermore, there is a close partnership with in which research results are shared to systematically build up and use knowledge in PCS care.
This research can contribute both to the development of a possible treatment and provide more insight into the genesic mechanism of PCS. The intended result is to demonstrate that sonlicromanol is an effective, safe and well-tolerated treatment for patients with PCS. The results of this study may also confirm that mitochondria play an important role in the disease.
If this study finds positive results with the study drug sonlicromanol, Khondrion has outlined that there is the possibility to scale up the production of the drug. This could lead to setting up large-scale studies to further evaluate and confirm effectiveness and safety.
Description adapted from project website: see link above.
Patient cohort
Post-COVID Syndrome (PCS) according to WHO with Post-Exertional Malaise (PEM).
Patients enrolled: 80
Age group: 18 - 65 years (Adults)
Research areas
2
Research types
1
Research networks
0
Working groups
0
People
1
Publications
0
Organisations
1
Research areas
Mitochondrial dysfunction
Description:
Mitochondrial diseases are conditions caused by abnormal function of the mitochondira.
Research projects:
9
Publications:
15
Nutritional and metabolic system dysfunction
Description:
A collective term for nutritional disorders resulting from poor absorption or nutritional imbalance, and metabolic disorders resulting from defects in biosynthesis (anabolism) or breakdown (catabolism) of endogenous substances.
Research projects:
17
Publications:
34