Taurine supplements for people with Long COVID

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled phase 2/3 trial testing oral taurine supplementation versus placebo in adults with persistent symptoms at least three months after acute COVID-19. Participants are recruited across multiple Canadian centers and must have ongoing Long COVID symptoms, including fatigue or cognitive complaints, that have been stable prior to enrollment. The trial measures changes in neurocognitive symptoms and fatigue as well as safety and tolerability of taurine supplementation. Results will compare symptom trajectories and adverse events between the taurine and placebo groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alberta Hospital, Kaye Edmonton Clinic
  Edmonton, Alberta, Canada Recruiting
• BC Women's Hospital
  Vancouver, British Columbia, Canada 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 Recruiting

Study contacts

• Principal investigator: Lawrence Richer, MD, MSc — University of Alberta
• Study coordinator: Lawrence Richer, MD, MSc
• Email: lricher@ualberta.ca
• Phone: 780-492-0943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.