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NCT05753228
In Vivo Investigation on Mitochondrial Dysfunction in Post-COVID Fatigue and Cancer Fatigue.
Conditions: Mitochondrial Dysfunction, COVID-19, Fatigue
Sex: All
Ages: 21 Years – 70 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: National University Hospital, Singapore
Location: Singapore
Summary
To date, little is understood regarding post-COVID fatigue or cancer fatigue though it is known to affect a large proportion of patients (10-70% depending on the population).
This study aims to investigate potential mitochondrial function and metabolic changes in brain to provide further information regarding the etiology of these changes leading to fatigue.This study hypothesized that Post-COVID fatigue is ensued by perturbations in metabolism and mitochondrial function in the brain.This is a case-control study.
In this study, 30 patients (experimental group) complaining of persistent fatigue lasting longer than 4 weeks after recovering from SARS-CoV-2 infection and the age/gender-matched control of 30 healthy subjects (control group 1) and 30 patients suffering from cancer-related fatigue patients longer than 4 weeks after remission (control group 2).
Both the experimental group (post-COVID fatigue) and control group 2 (cancer fatigue) will be recruited from NUH outpatient clinic will undergo a session of MRI, 3D Arterial Spin Labelling (ASL) and 1H magnetic resonance spectroscopy (MRS) and the Chalder Fatigue Scale, Health Questionnaire (EQ-5D-5L) and Hamilton Depression Rating Scale at baseline and follow-up visit.
Eligibility Criteria
Inclusion Criteria:age between 21 and 70 years old (all 3 groups)SARS-COV-2 disease confirmed by PCR or ART (experimental group)Chalder Fatigue Score (CFQ-11): >= 19 (experimental group and control group 2), =< 11 (control group 1)able to understand the study purpose and consent to it (all 3 groups)Exclusion Criteria:medically unstablecontraindications for MR scanning (metallic implants, claustrophobia)requiring oxygen supplementationunable to follow instructionsanemia (Hb < 10g/dl)thyroid disorderneoplasm (applicable only to experimental group and control group 1)premorbid sleep disorderpremorbid psychiatric disorders including depressionpregnancyepilepsy
Source: ClinicalTrials.gov (NCT05753228). StuddyBuddy aggregates publicly available trial information.