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Taurine Supplementation in Long COVID

Taurine Supplementation as a Novel Therapeutic Approach for Neurocognitive Symptoms in Long COVID

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06721949
Enrollment
300
Registered
2024-12-06
Start date
2025-11-18
Completion date
2028-12-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long COVID

Keywords

Taurine, COVID, Long COVID, randomized trial, neurocognitive symptoms

Brief summary

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.

Detailed description

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.

Interventions

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.

DRUGPlacebo

The placebo capsule is visually identical to the taurine capsule.

Sponsors

University of Alberta
Lead SponsorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University Health Network, Toronto
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Participants are assigned to one of two groups in parallel for the duration of the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥18 years; 2. Positive COVID-19 test by nasopharyngeal swab RT-PCR test, antibody or antigen tests at least 3 months prior to randomization; 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 randomization. 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 randomization. 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 (refer to Section 5 Contraception of the Master Protocol, and Section 13.1.2 of this protocol). 7. Must be able to provide informed consent and both willing and able to comply with study requirements. 8. Medications prescribed for treating fatigue or cognition have been discontinued for four weeks prior to enrolment and randomization. These include sildenafil, modafinil (Provigil), or armodafinil (Nuvigil), guanfacine, N-acetyl cysteine, and stimulant medications used for attention-deficit hyperactivity disorder (ADHD).

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 study intervention(s). 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 clinical trial to treat neurocognitive symptoms in LC.

Design outcomes

Primary

MeasureTime frameDescription
Mean change in Modified Fatigue Impact Scale (MFIS) from baseline to three monthsThree monthsThis study will target detection of a change in the MFIS from baseline to 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.Three monthsThis test will target detection of a change in the ratio of the Trail-Making Tests A \& B from baseline to three months

Secondary

MeasureTime frameDescription
Core Outcome Set - SymptomsThree monthsTracking of symptom trajectory from baseline to three months
Cardiovascular functionThree monthsMean change in results of 6-minute walking test, to include symptoms and conditions
Respiratory functionThree monthsMean change in results of 6-minute walking test, to include symptoms and conditions
Cognitive FunctionThree monthsMeasurement of mean change in cognition using the TestMyBrain assessment tool.
MemoryThree monthsMeasurement of mean change in memory using the TestMyBrain assessment tool.
ConcentrationThree monthsMeasurement of mean change in concentration using the TestMyBrain assessment tool.
Conceptual ThinkingThree monthsMeasurement of mean change in conceptual thinking using the TestMyBrain assessment tool.
Social FunctioningThree monthsMeasurement of mean change in social functioning using the TestMyBrain assessment tool.
Mental Health Status - PHQ-9Three monthsMeasurement of mean change in mental health status using the Patient Health Questionnaire (PHQ-9).
Mental Health Status - GAD-7Three monthsMeasurement of mean change in mental health status using the General Anxiety Disorder Questionnaire (GAD-7).
Post-Exertional Malaise (PEM) SymptomsThree monthsMeasurement 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).
Post-COVID-19 Functional Status (PCFS) ScaleThree monthsMeasurement of changes in post-COVID functional status using the Post-COVID-19 Functional Status (PCFS) Scale.
Reintegration to Normal Living Index (RNLI)Three monthsMeasurement of changes in reintegration to normal social activities using the Reintegration to Normal Living Index (RNLI) assessment tool.
Health Related Quality of Life - SF-36 (v.1)Three monthsMeasurement of change in quality of life using the Quality of Life - SF-36 (v.1) assessment tool.

Countries

Canada

Contacts

CONTACTLawrence Richer, MD, MSc
lricher@ualberta.ca780-492-0943
CONTACTEllen Morrison, PhD
taurineLC@ualberta.ca
PRINCIPAL_INVESTIGATORLawrence Richer, MD, MSc

University of Alberta

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026