Taurine Supplementation in Long COVID

NCT06721949 | Recruiting Phase 2 DMC

• 1 other identifier: RECLAIM -TaurineLC
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Long COVID

Keywords

Taurine; COVID; Long COVID; randomized trial; neurocognitive symptoms

Outcome Measures

Primary Outcomes (2)

• Mean 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

  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

  Three months

Secondary Outcomes (14)

• Core Outcome Set - Symptoms

  Three months

• Cardiovascular function

  Three months

• Respiratory function

  Three months

• Cognitive Function

  Three months

• Memory

  Three months

Study Arms (2)

Taurine

EXPERIMENTAL

Participants randomized to the Taurine arm will receive two 675 mg taurine capsules twice daily for 12 weeks.

Drug: Taurine

Placebo

PLACEBO COMPARATOR

Participants randomized to the Placebo arm will receive two placebo capsules twice daily for 12 weeks. The placebo capsules will be visually identical to the taurine capsules.

Drug: Placebo

Interventions

Taurine DRUG

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.

Taurine

Placebo DRUG

The placebo capsule is visually identical to the taurine capsule.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• 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.
• 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 randomization.
• 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).
• Must be able to provide informed consent and both willing and able to comply with study requirements.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead
• University Health Network, Toronto: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (5)

University of Alberta Hospital, Kaye Edmonton Clinic

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

NOT YET RECRUITING

University Health Network

Toronto, Ontario, Canada

RECRUITING

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

RECRUITING

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Taurine

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Lawrence Richer, MD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lawrence Richer, MD, MSc

CONTACT

780-492-0943; lricher@ualberta.ca

Ellen Morrison, PhD

CONTACT

taurineLC@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 6, 2024
• Study Start: November 18, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

CA (5)