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Taurine Supplementation in Adolescents With Post-COVID Condition (TaurineLCPeds)

11 sierpnia 2026 zaktualizowane przez: University of Alberta

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. Subjects must be between 10 and 17 years of age at the time of study enrollment
  2. 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.
  3. 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).
  4. 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.
  5. Lingering symptoms from COVID-19 present at the time of trial enrollment.
  6. 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.
  7. 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.
  8. Participants must be able to assent to their participation in the study and be both willing and able to comply with study requirements.
  9. Parents/caregivers/guardians must be able to provide informed consent for participation.
  10. Participants must agree to avoid taking supplemental taurine (e.g. from over-the-counter preparations, energy drinks, etc.)

Exclusion Criteria:

  1. Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19.
  2. Current end-organ failure, organ transplantation, or current hospitalization in an acute care hospital.
  3. Contraindications to the study intervention.
  4. Currently already on the study intervention (Participants would be eligible if they stopped taking Taurine for a minimum of 4 weeks prior to enrollment).
  5. Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted).
  6. Currently pregnant or breastfeeding.
  7. The participant is currently enrolled in another research trial to treat neurocognitive symptoms in LC.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Taurine Intervention
Participants will receive weight-based dosing of taurine capsules administered PO twice daily.
Lek: Byczy
Tauryna jest naturalnie występującym kwasem aminosulfonowym powszechnie występującym w organizmie. Jest sprzedawany jako naturalny produkt/suplement zdrowotny i odgrywa ważną rolę w organizmie.
Inne nazwy:
  • 2-Aminoethanesulfonic acid

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Change in Plasma Taurine Levels from Baseline to Three Months
Ramy czasowe: Three months
This study will measure the plasma taurine levels at baseline and following three months of taurine supplementation.
Three months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Fatigue
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Three months
Tracking of symptom trajectory from baseline to three months
Three months
Health Related Quality of Life
Ramy czasowe: Three months
Measurement of change in quality of life using the EQ-5D-Y-3L assessment tool.
Three months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Alberta

Współpracownicy

Canadian Institutes of Health Research (CIHR)

Śledczy

  • Główny śledczy: Lawrence Richer, MD, MSc, University of Alberta

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

30 września 2026

Zakończenie podstawowe (Szacowany)

31 marca 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

26 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

2 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • TaurineLCPeds

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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