The COVID-19 pandemic has swept across the globe, affecting millions of individuals with varying degrees of severity. While many individuals recover from the acute phase of the infection, a significant proportion continue to experience persistent and debilitating symptoms long after the initial SARS-CoV-2 infection. This condition, known as Long COVID (LC) or sometimes referred to as Post-COVID Condition (PCC) or post-acute sequelae of COVID-19, has emerged as a complex multisystemic condition and challenging health issue, affecting approximately 10% of COVID-19 patients. Various symptoms characterize LC, including fatigue, sleep disturbances, cognitive impairment, and mood disturbances. Some of the symptoms are shared with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) - a condition marked by debilitating fatigue and a host of other symptoms without precise biomarkers or objective tests for diagnosis. Effective LC treatments remain elusive and LC patients continue to grapple with persistent symptoms that significantly impact their quality of life. Given the lack of effective treatments, it is imperative to explore novel therapeutic approaches that may alleviate the suffering of this patient population.
Purpose: The overall trial objectives are to evaluate the efficacy and safety of taurine supplementation in treating and managing prolonged symptoms related to LC, focusing on neurocognitive-associated symptoms and fatigue. Hypothesis: Increasing taurine levels in the body through treatment with taurine supplements will have a beneficial effect on Long COVID symptoms particularly neurocognitive-associated symptoms and fatigue. Justification: Previous studies have suggested a correlation between low plasma taurine levels and symptoms associated with Long COVID. Reduced plasma taurine levels have also been observed in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The decreasing trajectory of taurine levels observed in long COVID could partly explain the fatigue, as taurine plays multiple roles in skeletal muscle function, the central nervous system, and energy metabolism. Furthermore, in various clinical and preclinical studies, including antioxidant, anti-aging, cytoprotective, and cardioprotective effects, taurine has demonstrated various therapeutic activities. Taurine also has a role in neuromodulation and the treatment of other central nervous system disorders, including depression. These findings suggest that taurine may be important in addressing the persistent symptoms and adverse outcomes in LC patients. Given the robust association between taurine levels and symptoms and adverse outcomes of LC and the safety profile, there is a strong biological and clinical rationale for investigating taurine supplementation. There is a lack of effective treatments for LC, and exploring taurine supplementation as a novel therapeutic approach is justified and holds the potential to significantly improve the lives of affected individuals with an excellent safety profile. Objectives: The overall trial objectives are to evaluate the efficacy and safety of taurine supplementation in treating and managing prolonged symptoms related to LC, focusing on neurocognitive-associated symptoms and fatigue.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
University of Alberta Hospital, Kaye Edmonton Clinic
Edmonton, Alberta, Canada
RECRUITINGUniversity Health Network
Toronto, Ontario, Canada
NOT_YET_RECRUITINGInstitut de recherches cliniques de Montréal
Montreal, Quebec, Canada
NOT_YET_RECRUITINGCentre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
NOT_YET_RECRUITINGMean change in Modified Fatigue Impact Scale (MFIS) from baseline to three months
This study will target detection of a change in the MFIS from baseline to three months
Time frame: Three months
Mean change in the ratio of the Trail-Making Tests A & B in the TestMyBrain cognitive testing battery from baseline to three months.
This test will target detection of a change in the ratio of the Trail-Making Tests A \& B from baseline to three months
Time frame: Three months
Core Outcome Set - Symptoms
Tracking of symptom trajectory from baseline to three months
Time frame: Three months
Cardiovascular function
Mean change in results of 6-minute walking test, to include symptoms and conditions
Time frame: Three months
Respiratory function
Mean change in results of 6-minute walking test, to include symptoms and conditions
Time frame: Three months
Cognitive Function
Measurement of mean change in cognition using the TestMyBrain assessment tool.
Time frame: Three months
Memory
Measurement of mean change in memory using the TestMyBrain assessment tool.
Time frame: Three months
Concentration
Measurement of mean change in concentration using the TestMyBrain assessment tool.
Time frame: Three months
Conceptual Thinking
Measurement of mean change in conceptual thinking using the TestMyBrain assessment tool.
Time frame: Three months
Social Functioning
Measurement of mean change in social functioning using the TestMyBrain assessment tool.
Time frame: Three months
Mental Health Status - PHQ-9
Measurement of mean change in mental health status using the Patient Health Questionnaire (PHQ-9).
Time frame: Three months
Mental Health Status - GAD-7
Measurement of mean change in mental health status using the General Anxiety Disorder Questionnaire (GAD-7).
Time frame: Three months
Post-Exertional Malaise (PEM) Symptoms
Measurement of changes in onset and triggers of PEM, symptoms, duration and recovery using the Post-Exertional Malaise questionnaire, adapted from De Paul's Symptom Questionnaire (PEM-DSQ).
Time frame: Three months
Post-COVID-19 Functional Status (PCFS) Scale
Measurement of changes in post-COVID functional status using the Post-COVID-19 Functional Status (PCFS) Scale.
Time frame: Three months
Reintegration to Normal Living Index (RNLI)
Measurement of changes in reintegration to normal social activities using the Reintegration to Normal Living Index (RNLI) assessment tool.
Time frame: Three months
Health Related Quality of Life - SF-36 (v.1)
Measurement of change in quality of life using the Quality of Life - SF-36 (v.1) assessment tool.
Time frame: Three months
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