Taurine for Post-COVID Syndrome

Overseen By Ellen Morrison, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Alberta

Must not be taking: Sildenafil, Modafinil, Armodafinil, others

Disqualifiers: Mechanical ventilation, Organ failure, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications. Specifically, if you are taking medications for fatigue or cognition like sildenafil, modafinil, armodafinil, guanfacine, N-acetyl cysteine, or ADHD stimulants, you must stop them at least four weeks before joining the trial.

Is taurine safe for human use?

Taurine is generally considered safe for human use and is found in many energy drinks. It has been studied for its protective effects in various conditions, including heart and liver diseases, and has shown potential benefits without significant safety concerns. ^{1 2 3 4 5}

How does the drug taurine differ from other treatments for post-COVID syndrome?

Taurine is unique because it is an amino acid that may help reduce oxidative stress and inflammation, which are important in COVID-19. Unlike other treatments, taurine has potential antiviral, antioxidant, and anti-inflammatory effects, making it a promising option for managing post-COVID syndrome. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Lawrence Richer, MD, MSc

Principal Investigator

University of Alberta

Eligibility Criteria

Adults over 18 who had COVID-19 at least 3 months ago and have been dealing with Long COVID symptoms for at least 2 months can join. They must not be on certain medications for fatigue or cognition, agree to use effective contraception if applicable, and be able to follow the study rules.

Inclusion Criteria

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 with acute illness after October 15, 2019, and at least 3 months prior to randomization

My treatment for symptoms has been stable for at least 4 weeks.

Individuals of childbearing potential who are sexually active must agree to practice true abstinence or use at least one highly effective method of contraception while on study treatment

Exclusion Criteria

The participant is currently enrolled in another clinical trial to treat neurocognitive symptoms in LC

I have no health conditions that prevent me from receiving the study treatment.

Currently already on study intervention(s)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive taurine or placebo capsules twice daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Taurine

Trial Overview The trial is testing whether Taurine supplements can help people with Long COVID feel better compared to a placebo (a pill without any medicine). Participants will randomly receive either Taurine or the placebo.

Participant Groups

Group I: Taurine Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The Disease-Modifying Role of Taurine and Its Therapeutic Potential in Coronavirus Disease 2019 (COVID-19). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Examination of Taurine Chloramine and Taurine on LPS-Induced Acute Pulmonary Inflammatory in Mice. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effect of intravenous taurine on endotoxin-induced acute lung injury in sheep. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effects of taurine and guanidinoethane sulfonate on toxicity of the pyrrolizidine alkaloid monocrotaline. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Taurine and cardiac disease: state of the art and perspectives. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Inhibition of septic arthritis by local administration of taurine chloramine, a product of activated neutrophils. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Effects of in-vivo administration of taurine and HEPES on the inflammatory response in rats. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Immunonutrition: the role of taurine. [2019]