COVID-19 Clinical Trial
Official title:
In Vivo Investigation on Mitochondrial Dysfunction in Post-COVID Fatigue and Cancer Fatigue.
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 8, 2023 |
Est. primary completion date | December 8, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility | 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 unstable - contraindications for MR scanning (metallic implants, claustrophobia) - requiring oxygen supplementation - unable to follow instructions - anemia (Hb < 10g/dl) - thyroid disorder - neoplasm (applicable only to experimental group and control group 1) - premorbid sleep disorder - premorbid psychiatric disorders including depression - pregnancy - epilepsy |
Country | Name | City | State |
---|---|---|---|
Singapore | Jeong Hoon K Lim | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore | National University of Singapore |
Singapore,
Blomberg B, Mohn KG, Brokstad KA, Zhou F, Linchausen DW, Hansen BA, Lartey S, Onyango TB, Kuwelker K, Saevik M, Bartsch H, Tondel C, Kittang BR; Bergen COVID-19 Research Group; Cox RJ, Langeland N. Long COVID in a prospective cohort of home-isolated patients. Nat Med. 2021 Sep;27(9):1607-1613. doi: 10.1038/s41591-021-01433-3. Epub 2021 Jun 23. — View Citation
Filler K, Lyon D, Bennett J, McCain N, Elswick R, Lukkahatai N, Saligan LN. Association of Mitochondrial Dysfunction and Fatigue: A Review of the Literature. BBA Clin. 2014 Jun 1;1:12-23. doi: 10.1016/j.bbacli.2014.04.001. — View Citation
Kantarci K, Reynolds G, Petersen RC, Boeve BF, Knopman DS, Edland SD, Smith GE, Ivnik RJ, Tangalos EG, Jack CR Jr. Proton MR spectroscopy in mild cognitive impairment and Alzheimer disease: comparison of 1.5 and 3 T. AJNR Am J Neuroradiol. 2003 May;24(5):843-9. — View Citation
Lin DD, Crawford TO, Barker PB. Proton MR spectroscopy in the diagnostic evaluation of suspected mitochondrial disease. AJNR Am J Neuroradiol. 2003 Jan;24(1):33-41. — View Citation
Logue JK, Franko NM, McCulloch DJ, McDonald D, Magedson A, Wolf CR, Chu HY. Sequelae in Adults at 6 Months After COVID-19 Infection. JAMA Netw Open. 2021 Feb 1;4(2):e210830. doi: 10.1001/jamanetworkopen.2021.0830. Erratum In: JAMA Netw Open. 2021 Mar 1;4(3):e214572. — View Citation
Miller B, Silverstein A, Flores M, Cao K, Kumagai H, Mehta HH, Yen K, Kim SJ, Cohen P. Host mitochondrial transcriptome response to SARS-CoV-2 in multiple cell models and clinical samples. Sci Rep. 2021 Jan 8;11(1):3. doi: 10.1038/s41598-020-79552-z. — View Citation
Tomas C, Brown A, Strassheim V, Elson JL, Newton J, Manning P. Correction: Cellular bioenergetics is impaired in patients with chronic fatigue syndrome. PLoS One. 2018 Feb 8;13(2):e0192817. doi: 10.1371/journal.pone.0192817. eCollection 2018. — View Citation
Tomas C, Lodge TA, Potter M, Elson JL, Newton JL, Morten KJ. Assessing cellular energy dysfunction in CFS/ME using a commercially available laboratory test. Sci Rep. 2019 Aug 7;9(1):11464. doi: 10.1038/s41598-019-47966-z. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI, 3D Arterial Spin Labelling (ASL) and 1H magnetic resonance spectroscopy (MRS) | The MRI, 3D Arterial Spin Labelling (ASL) and 1H magnetic resonance spectroscopy (MRS) are used to assess metabolic and mitochondrial perturbations in post-COVID fatigue or cancer fatigue. | 90 minutes | |
Primary | Chalder Fatigue Scale | Chalder Fatigue Scale is a self-administered questionnaire for measuring the extent and severity of fatigue within both clinical and non-clinical, epidemiological populations. Each of the 11 items are answered on a 4-point scale ranging from the asymptomatic to maximum symptomology, such as 'Better than usual', 'No worse than usual', 'Worse than usual' and 'Much worse than usual'. For all items, the least symptomatic answers are on the left of the response-set, providing an easy-to-understand checklist for respondents. Using the Likert scoring method, responses on the extreme left receive a score of 0, increasing to 1, 2 or 3 as they become more symptomatic. The respondent's global score can range from 0 to 33. The global score also spans two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11). The Likert scoring system allows for means and distributions to be calculated for both the global total as well as the two sub-scales. | 5 minutes | |
Primary | Health Questionnaire (EQ-5D-5L) | The Health Questionnaire (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems." The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | 5 minutes | |
Primary | Hamilton Depression Rating Scale | The Hamilton Depression Rating Scale is used to quantify the severity of symptoms of depression and is one of the most widely used and accepted instruments for assessing depression. Method for scoring varies by version. For the HDRS17, a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial. | 10 minutes |
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