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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Sonlicromanol 90mg twice daily for 13 weeks
Placebo twice daily for 13 weeks
Amsterdam University Medical Center, Location Academic Medical Center (AMC)
Amsterdam, North Holland, Netherlands
RECRUITINGFatigue
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 13
Muscle strength
Muscle strength measured with the Repeated Handgrip Strength of the dominant hand
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Between group differences at week 13
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