Sonlicromanol in Post-COVID
ConditionPost COVID Condition
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMichele van Vugt
About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sonlicromanol
DrugSonlicromanol 90mg twice daily for 13 weeks
Placebo
DrugPlacebo twice daily for 13 weeks
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Between group differences at week 13Secondary outcomes
1
Muscle strength
Muscle strength measured with the Repeated Handgrip Strength of the dominant hand
Time frame
Between group differences at week 132
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
Time frame
Between group differences at week 133
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
Time frame
Between group differences at week 134
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
Time frame
Between group differences at week 13Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Michele van Vugt
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor institution
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Khondrion BV
Collaborator
Source ClinicalTrials.gov