The COVID-19 pandemic has swept across the globe, affecting millions of individuals withvarying degrees of severity. While many individuals recover from the acute phase of theinfection, a significant proportion continue to experience persistent and debilitatingsymptoms 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 ofCOVID-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. Someof the symptoms are shared with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome(ME/CFS) - a condition marked by debilitating fatigue and a host of other symptomswithout precise biomarkers or objective tests for diagnosis. Effective LC treatmentsremain elusive and LC patients continue to grapple with persistent symptoms thatsignificantly impact their quality of life. Given the lack of effective treatments, it isimperative to explore novel therapeutic approaches that may alleviate the suffering ofthis patient population.
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.
Drug: Taurine
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.
Drug: Placebo
The placebo capsule is visually identical to the taurine capsule.
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.
University of Alberta Hospital, Kaye Edmonton Clinic
Edmonton, Alberta, Canada
Investigator: Grace Lam, MD
glam@ualberta.ca
Lawrence Richer, MD, MSc
780-492-0943
lricher@ualberta.ca
Ellen Morrison, PhD
ejmorris@ualberta.ca
Lawrence Richer, MD, MSc, Principal Investigator
University of Alberta