Taurine Supplementation in Adolescents With Post-COVID Condition (TaurineLCPeds)
An Open-Label Study of Taurine Supplementation in Adolescents With Post-COVID Condition: Quantifying Taurine Plasma Levels and Evaluating Clinical and Biological Outcomes
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Lawrence Richer, MD, MSc
- 電話番号:780-492-0943
- メール:lricher@ualberta.ca
研究連絡先のバックアップ
- 名前:Ellen Morrison, PhD
- メール:taurineLC@ualberta.ca
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Subjects must be between 10 and 17 years of age at the time of study enrollment
- Positive COVID-19 test by nasopharyngeal swab RT-PCR test, antibody or antigen tests at least 3 months prior to trial; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019, and at least 3 months prior to trial enrollment.
- If participants have treatable symptoms, they should have had a stable regimen of treatment prior to entering the study (i.e. started treatment for at least 4 weeks).
- Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive testing or the date of first symptoms.
- Lingering symptoms from COVID-19 present at the time of trial enrollment.
- Individuals of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use at least one highly effective method of contraception while on study treatment. Highly effective methods of contraception must be discussed and approved by the overseeing Investigator.
- Medication(s) only available through a prescription for the purposes of treating fatigue or cognitive function have been discontinued for four weeks prior to randomization.
- Participants must be able to assent to their participation in the study and be both willing and able to comply with study requirements.
- Parents/caregivers/guardians must be able to provide informed consent for participation.
- Participants must agree to avoid taking supplemental taurine (e.g. from over-the-counter preparations, energy drinks, etc.)
Exclusion Criteria:
- Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19.
- Current end-organ failure, organ transplantation, or current hospitalization in an acute care hospital.
- Contraindications to the study intervention.
- Currently already on the study intervention (Participants would be eligible if they stopped taking Taurine for a minimum of 4 weeks prior to enrollment).
- Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted).
- Currently pregnant or breastfeeding.
- The participant is currently enrolled in another research trial to treat neurocognitive symptoms in LC.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Taurine Intervention
Participants will receive weight-based dosing of taurine capsules administered PO twice daily.
|
タウリンは、体内で一般的に見られる天然に存在するアミノスルホン酸です。
天然の健康製品/サプリメントとして販売されており、体内で重要な役割を果たしています。
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change in Plasma Taurine Levels from Baseline to Three Months
時間枠:Three months
|
This study will measure the plasma taurine levels at baseline and following three months of taurine supplementation.
|
Three months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fatigue
時間枠:Three months
|
This study will target detection of a change in the PROMIS Pediatric Fatigue Short Form from baseline to three months
|
Three months
|
|
Cognitive Function
時間枠:Three months
|
This study will target detection of a change in the PROMIS Pediatric Cognitive Function Short Form from baseline to three months
|
Three months
|
|
Cardiovascular
時間枠:Three months
|
This study will target detection of a change in heart rate and heart rate variability from baseline to three months
|
Three months
|
|
Core Outcome Symptoms
時間枠:Three months
|
Tracking of symptom trajectory from baseline to three months
|
Three months
|
|
Health Related Quality of Life
時間枠:Three months
|
Measurement of change in quality of life using the EQ-5D-Y-3L assessment tool.
|
Three months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Lawrence Richer, MD, MSc、University of Alberta
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TaurineLCPeds
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。