- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06721949
Taurine Supplementation in Long COVID
Taurine Supplementation as a Novel Therapeutic Approach for Neurocognitive Symptoms in Long COVID
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Lawrence Richer, MD, MSc
- Phone Number: 780-492-0943
- Email: lricher@ualberta.ca
Study Contact Backup
- Name: Ellen Morrison, PhD
- Email: taurineLC@ualberta.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2B7
- Recruiting
- University of Alberta Hospital, Kaye Edmonton Clinic
-
Contact:
- Grace Lam, MD
- Email: glam@ualberta.ca
-
Contact:
- Amanda Newman
- Email: taurineLC@ualberta.ca
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6H 3N1
- Not yet recruiting
- BC Women's Hospital
-
Contact:
- Karen Tran, MD
- Email: Karen.Tran@cw.bc.ca
-
Contact:
- Alia Izquierdo
- Email: alia.izquierdo@phsa.ca
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-
Ontario
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Toronto, Ontario, Canada
- Recruiting
- University Health Network
-
Contact:
- Suzanne Cohen
- Email: reclaim@uhn.ca
-
Contact:
- Angela Cheung, MD
- Email: Angela.Cheung@uhn.ca
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-
Quebec
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Montreal, Quebec, Canada
- Recruiting
- Institut de recherches cliniques de Montreal
-
Contact:
- Liana Falcone, MD
- Email: emilia.falcone@ircm.qc.ca
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Contact:
- Charlotte Du Sablon
- Email: postcovid@ircm.ca
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Sherbrooke, Quebec, Canada
- Not yet recruiting
- Centre integre universitaire de sante et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
-
Contact:
- Alain Piché, MD
- Email: Alain.Piche@usherbrooke.ca
-
Contact:
- Christine Rioux-Perreault
- Email: christine.rioux-perreault.ciussse-chus@ssss.gouv.qc.ca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Taurine
Participants randomized to the Taurine arm will receive two 675 mg taurine capsules twice daily for 12 weeks.
|
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.
|
|
Placebo Comparator: Placebo
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.
|
The placebo capsule is visually identical to the taurine capsule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change in Modified Fatigue Impact Scale (MFIS) from baseline to three months
Time Frame: 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.
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core Outcome Set - Symptoms
Time Frame: Three months
|
Tracking of symptom trajectory from baseline to three months
|
Three months
|
|
Cardiovascular function
Time Frame: Three months
|
Mean change in results of 6-minute walking test, to include symptoms and conditions
|
Three months
|
|
Respiratory function
Time Frame: Three months
|
Mean change in results of 6-minute walking test, to include symptoms and conditions
|
Three months
|
|
Cognitive Function
Time Frame: Three months
|
Measurement of mean change in cognition using the TestMyBrain assessment tool.
|
Three months
|
|
Memory
Time Frame: Three months
|
Measurement of mean change in memory using the TestMyBrain assessment tool.
|
Three months
|
|
Concentration
Time Frame: Three months
|
Measurement of mean change in concentration using the TestMyBrain assessment tool.
|
Three months
|
|
Conceptual Thinking
Time Frame: Three months
|
Measurement of mean change in conceptual thinking using the TestMyBrain assessment tool.
|
Three months
|
|
Social Functioning
Time Frame: Three months
|
Measurement of mean change in social functioning using the TestMyBrain assessment tool.
|
Three months
|
|
Mental Health Status - PHQ-9
Time Frame: Three months
|
Measurement of mean change in mental health status using the Patient Health Questionnaire (PHQ-9).
|
Three months
|
|
Mental Health Status - GAD-7
Time Frame: Three months
|
Measurement of mean change in mental health status using the General Anxiety Disorder Questionnaire (GAD-7).
|
Three months
|
|
Post-COVID-19 Functional Status (PCFS) Scale
Time Frame: Three months
|
Measurement of changes in post-COVID functional status using the Post-COVID-19 Functional Status (PCFS) Scale.
|
Three months
|
|
Reintegration to Normal Living Index (RNLI)
Time Frame: Three months
|
Measurement of changes in reintegration to normal social activities using the Reintegration to Normal Living Index (RNLI) assessment tool.
|
Three months
|
|
Post-Exertional Malaise (PEM) Symptoms
Time Frame: Three months
|
Measurement 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).
|
Three months
|
|
Health Related Quality of Life - SF-36 (v.1)
Time Frame: Three months
|
Measurement of change in quality of life using the Quality of Life - SF-36 (v.1) assessment tool.
|
Three months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lawrence Richer, MD, MSc, University of Alberta
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- COVID-19
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Post-Acute COVID-19 Syndrome
- Sulfur Compounds
- Organic Chemicals
- Hydrocarbons, Acyclic
- Hydrocarbons
- Alkanes
- Alkanesulfonic Acids
- Sulfonic Acids
- Sulfur Acids
- Taurine
Other Study ID Numbers
- RECLAIM -TaurineLC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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