Clinical trial NCT05152849: Efficacy, Safety, Tolerability of AXA1125 in Fatigue After COVID-19 Infection
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of AXA1125 in Subjects With Fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
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
Lead sponsor: Axcella Health, Inc
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS)
timeFrame: Baseline to 28 days
Secondary outcomes:
measure: Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS)
timeFrame: Baseline to 28 days
measure: Proportion of subjects with improvement in PCr recovery rate
timeFrame: Baseline to 28 days
measure: Change from baseline in serum lactate level after a 6-minute walk test
timeFrame: Baseline to 28 days
measure: Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT
timeFrame: Baseline to 28 days
measure: Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT
timeFrame: Baseline to 28 days
measure: Change from baseline in distance traveled during a 6MWT
timeFrame: Baseline to 28 days
measure: Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11
timeFrame: Baseline to14 days
measure: Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 before and after a 6MWT
timeFrame: Baseline to 28 days
measure: Proportion of subjects with an improvement in fatigue score as assessed by CFQ-11 before and after a 6MWT
timeFrame: Baseline to 28 days
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Betty Raman, MBBS DPhil FRACP
role: PRINCIPAL_INVESTIGATOR
References: