Taurine Supplementation in Long COVID

ConditionLong COVID
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Drug

    The placebo capsule is visually identical to the taurine capsule.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: TaurineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Three months
2

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

Time frame
Three months

Secondary outcomes

1

Core Outcome Set - Symptoms

Tracking of symptom trajectory from baseline to three months

Time frame
Three months
2

Cardiovascular function

Mean change in results of 6-minute walking test, to include symptoms and conditions

Time frame
Three months
3

Respiratory function

Mean change in results of 6-minute walking test, to include symptoms and conditions

Time frame
Three months
4

Cognitive Function

Measurement of mean change in cognition using the TestMyBrain assessment tool.

Time frame
Three months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

University Health Network, Toronto

Collaborator