Amsterdam University Medical Center, Location Academic Medical Center (AMC)
Amsterdam, North Holland, 1105 AZ, Netherlands
Location status: Recruiting
NCT Number: NCT07298005
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).
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2
Amsterdam, North Holland, 1105 AZ, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sonlicromanol 90mg twice daily for 13 weeks
Placebo twice daily for 13 weeks
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
Time frame: Between group differences at week 13
Muscle strength measured with the Repeated Handgrip Strength of the dominant hand
Time frame: Between group differences at week 13
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 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
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
Michele van Vugt
Other
SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial
Acronym: SON4PEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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