Taurine for Post-COVID Syndrome

Recruiting at 3 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests taurine, a natural compound, to determine its effectiveness for Long COVID. Long COVID occurs when symptoms like tiredness, trouble sleeping, and brain fog persist for months after the initial COVID-19 infection. Participants will receive either taurine or a placebo (a pill with no active ingredient) to compare outcomes. This trial suits individuals with lingering COVID-19 symptoms for at least three months after their initial infection. As a Phase 2, Phase 3 trial, the research measures taurine's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to important advancements in Long COVID treatment.

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 there any evidence suggesting that taurine is likely to be safe for humans?

Research has shown that taurine, a type of amino acid, is under investigation for its safety in treating Long COVID symptoms. Small studies indicate that taurine is usually well-tolerated, with no harmful side effects reported. This suggests taurine might be safe, but further research is necessary for confirmation. Additionally, researchers are exploring taurine's potential role in alleviating Long COVID symptoms, though this treatment remains under evaluation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Long COVID?

Researchers are excited about using taurine for post-COVID syndrome because it offers a unique approach compared to current treatments, which often focus on symptom management through physical therapy, psychological support, and medications like pain relievers or antidepressants. Taurine is an amino acid that acts as an antioxidant, potentially reducing inflammation and oxidative stress, which are believed to contribute to post-COVID symptoms. This new mechanism of action could address the root causes of these lingering symptoms, providing a more comprehensive relief than existing options. Additionally, taurine's established safety profile as a dietary supplement makes it a promising candidate for long-term use in managing post-COVID syndrome.

What evidence suggests that taurine might be an effective treatment for Post-COVID Syndrome?

Research has shown that taurine, a natural substance in the body, might alleviate ongoing symptoms of Long COVID. Studies have found that people with Long COVID often have lower taurine levels, which may correlate with more severe symptoms. Taurine supplements have shown promise in reducing symptoms like fatigue and mood issues. In this trial, participants in the taurine arm will receive taurine supplements to evaluate their effectiveness. Some researchers believe taurine could play a crucial role in treating Long COVID by enhancing overall health. These findings suggest taurine could be a helpful option for those dealing with the long-term effects of COVID-19. ^{1 2 6 7 8}

Who Is on the Research Team?

Lawrence Richer, MD, MSc

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11152273/

Plasma taurine level is linked to symptom burden and clinical ... This study aims to evaluate the association between plasma taurine levels with self-reported symptoms and adverse clinical outcomes in patients with PCC.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06721949?term=AREA%5BConditionSearch%5D(COVID)&rank=9

NCT06721949 | Taurine Supplementation in Long COVID Hypothesis: Increasing taurine levels in the body through treatment with taurine supplements will have a beneficial effect on Long COVID symptoms particularly ...

3. clinicaltrial.be clinicaltrial.be/en/details/520377?per_page=100&condition[0]=PASC%20Post%20Acute%20Sequelae%20of%20COVID%2019&condition[1]=Long%20COVID&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Taurine Supplementation in Long COVID These findings suggest that taurine may be important in addressing the persistent symptoms and adverse outcomes in LC patients. Given the robust ...

4. ualberta.ca ualberta.ca/en/folio/2023/10/researchers-identify-amino-acid-that-may-play-key-role-for-predicting-treating-long-covid.html

Researchers identify amino acid that may play a key role ... University of Alberta researchers have identified an amino acid that may play a key role in predicting poor clinical outcomes and the treatment of long COVID.

5. nature.com nature.com/articles/s41598-023-39049-x

The plasma metabolome of long COVID patients two years ... Holmes et al. found that taurine levels were increased in post-COVID-19 patients, suggesting hepatic injury, hepatotoxicity, or muscle damage.

6. ctv.veeva.com ctv.veeva.com/study/taurine-supplementation-in-long-covid

Taurine Supplementation in Long COVID - ClinicalTrials.Veeva Hypothesis: Increasing taurine levels in the body through treatment with taurine supplements will have a beneficial effect on Long COVID ...

7. meassociation.org.uk meassociation.org.uk/2023/10/researchers-identify-amino-acid-that-may-play-a-key-role-for-predicting-and-treating-long-covid/

Researchers identify amino acid that may play a key role ... Further study of the impact of taurine supplementation in humans is needed, says Oudit, but existing small studies show no harmful side-effects ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666337625001027

Impact of nutrition on long COVID Nutritional modification plays a significant role in managing chronic inflammatory conditions, including those seen in long COVID specific ...