Efficacy, Safety, Tolerability of AXA1125 in Fatigue After COVID-19 Infection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection

Intervention / Treatment
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* Drug: AXA1125
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXA1125 33.9g<br>33.9 g AXA1125 administered orally BID with or without food | Drug: AXA1125<br>* AXA1125 administered BID with or without food<br>|
| Placebo Comparator: Placebo<br>Matching Placebo administered orally BID with or without food | Drug: Placebo<br>* Matching Placebo administered BID with or without food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS) |  | Baseline to 28 days | 
| 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 distance traveled during a 6MWT |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skeletal muscle, Long COVID, Long-haul COVID, Muscle weakness, COVID, PASC, Fatigue, Amino acids, Bioenergetics, Mitochondrial dysfunction, Phosphocreatine recovery, Exertional fatigue, Phospho magnetic resonance spectroscopy