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 (PASC), has emerged as a complex multisystemic condition and challenging public health issue. Contrary to initial perceptions, pediatric Long COVID is a significant health concern, with studies suggesting its prevalence ranges from 10% to 25% following infection. Research in the pediatric population has largely been limited to observational studies based on self-reported symptoms or large electronic healthcare datasets. The long-term outcomes and predictors of LC in children remain poorly described, highlighting an urgent need for further mechanistic research to characterize this complex condition. While acute COVID-19 symptoms are often milder in children relative to adults, some go on to develop a range of chronic physical, immunological, psychological, and neurological symptoms persisting for weeks to years after initial infection. The most commonly reported symptoms are similar to those seen in adults and include debilitating fatigue, respiratory distress, headaches, gastrointestinal symptoms, and neurocognitive impairment. Other frequently reported symptoms include muscle pain, sleep disturbances, olfactory and gustatory disturbances, exercise intolerance, and heart palpitations/cardiovascular symptoms. These symptoms can be new, or they may persist or fluctuate from the initial illness. Additionally, many children with LC experience psychological symptoms such as anxiety, depression, and mood disturbances, which are thought to be exacerbated by experiencing prolonged illness and subsequent lifestyle disruptions. Currently, effective treatments for LC remain elusive, leaving patients to contend with persistent symptoms that significantly impair their quality of life. For children and adolescents, these issues can profoundly impact their daily activities, academic performance, and social interactions/friendships. Symptoms like debilitating fatigue, cognitive impairment, and mood disturbances are especially disruptive by interfering with memory, energy levels, and overall development, often leading to school absenteeism, social withdrawal, and psychological distress. Therefore, it is imperative to explore novel therapeutic approaches that may alleviate the suffering of this patient population.
Purpose: The primary objective is to quantify the increase in plasma taurine concentrations in adolescents following three months of taurine supplementation and evaluate the efficacy and safety of taurine supplementation in treating and managing prolonged symptoms related to LC. 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. 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 in adolescents, 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 to quantify the increase in plasma taurine concentrations in adolescents following three months of taurine supplementation and evaluate the efficacy and safety of taurine supplementation in treating and managing prolonged symptoms related to LC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Taurine is a naturally occurring amino sulfonic acid commonly found in the body. It is marketed as a natural health product/supplement and plays an important role in the body.
Mean Change in Plasma Taurine Levels from Baseline to Three Months
This study will measure the plasma taurine levels at baseline and following three months of taurine supplementation.
Time frame: Three months
Fatigue
This study will target detection of a change in the PROMIS Pediatric Fatigue Short Form from baseline to three months
Time frame: Three months
Cognitive Function
This study will target detection of a change in the PROMIS Pediatric Cognitive Function Short Form from baseline to three months
Time frame: Three months
Cardiovascular
This study will target detection of a change in heart rate and heart rate variability from baseline to three months
Time frame: Three months
Core Outcome Symptoms
Tracking of symptom trajectory from baseline to three months
Time frame: Three months
Health Related Quality of Life
Measurement of change in quality of life using the EQ-5D-Y-3L assessment tool.
Time frame: Three months
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