Post COVID ConditionPhase 2SON4PEMNCT07298005
Sonlicromanol in Post-COVID
A Phase 2 study testing Sonlicromanol in people with Post COVID Condition, run by Michele van Vugt at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post COVID Condition
- What is being tested?
- Sonlicromanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Apr 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center, Location Academic Medical Center (AMC)
Amsterdam, North Holland, 1105 AZ
Bastienne De Jonghe, MD, 020 566 9111, postcovidtrials@amsterdamumc.nl
About this study
Official title: SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial
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
- Post COVID Condition
- Being tested
- Sonlicromanol, Placebo
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonlicromanolDrug
Sonlicromanol 90mg twice daily for 13 weeks
PlaceboDrug
Placebo twice daily for 13 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Drug: Sonlicromanol |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
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
Measured: Between group differences at week 13
Secondary outcomes (4)
Muscle strength
Muscle strength measured with the Repeated Handgrip Strength of the dominant hand
Measured: Between group differences at week 13
Cognitive function
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
Measured: Between group differences at week 13
Health related quality of life
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
Measured: Between group differences at week 13
Fatigue
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
Measured: Between group differences at week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start3 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michele van Vugt
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Khondrion BV
- Responsible party
- Sponsor-investigator, Michele van Vugt, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298005
- Sponsor's protocol ID
- 2025-521866-92-01
- Other IDs
- 2025
- Acronym
- SON4PEM
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial
- ClinicalTrials.gov ID
- NCT07298005
- Acronym / sponsor ID
- SON4PEM / 2025-521866-92-01
- Conditions
- Post COVID Condition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Michele van VugtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Khondrion BV
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Sonlicromanol |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonlicromanolSonlicromanol 90mg twice daily for 13 weeks | Drug | Intervention group |
| PlaceboPlacebo twice daily for 13 weeks | Drug | Placebo group |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amsterdam University Medical Center, Location Academic Medical Center (AMC)
Amsterdam, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sonlicromanol in people with Post COVID Condition, run by Michele van Vugt at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Between group differences at week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.