Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
Conditions
Keywords
Long COVID, Long-haul COVID, Muscle weakness, COVID, PASC, Fatigue, Amino acids, Bioenergetics, Mitochondrial dysfunction, Phosphocreatine recovery, Exertional fatigue, Phospho magnetic resonance spectroscopy, Skeletal muscle
Brief summary
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving muscle function (metabolism) following moderate exercise in subjects with fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 as well as the safety and tolerability of AXA1125. Subjects will take one dose of AXA1125 or a placebo twice daily for 28 days.
Interventions
DRUGAXA1125
AXA1125 administered BID with or without food
DRUGPlacebo
Matching Placebo administered BID with or without food
Sponsors
Axcella Health, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Willing to participate in the study and provide written informed consent * Male and female adults aged \> 18 years and less than 65 years * Must have had clinically suspected COVID-19 and a positive antibody test or a documented SARS-CoV-2 infection (a positive reverse transcription polymerase chain reaction test) at least 12 weeks prior to Screening * Must have fatigue-predominant PASC * Other than PASC, a subject must be in good health without other significant medical or not well controlled medical or psychiatric conditions
Exclusion criteria
* Other than PASC, have an explanation for fatigue * Other than PASC, a history or presence of an uncontrolled, clinically significant disease * Medical history that includes of Non-invasive or invasive ventilatory support for COVID 19, Intensive care unit or other high dependency unit admission for COVID-19, Hospitalization for \>1 week for COVID-19 without intubation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS) | Baseline to 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with improvement in PCr recovery rate | Baseline to 28 days |
| Change from baseline in serum lactate level after a 6-minute walk test | Baseline to 28 days |
| Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT | Baseline to 28 days |
| Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT | Baseline to 28 days |
| Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS) | Baseline to 28 days |
| Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 | Baseline to14 days |
| Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 before and after a 6MWT | Baseline to 28 days |
| Proportion of subjects with an improvement in fatigue score as assessed by CFQ-11 before and after a 6MWT | Baseline to 28 days |
| Change from baseline in distance traveled during a 6MWT | Baseline to 28 days |
Countries
United Kingdom
Outcome results
None listed