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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXA1125 33.9g | Experimental | 33.9 g AXA1125 administered orally BID with or without food |
|
| Placebo | Placebo Comparator | Matching Placebo administered orally BID with or without food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXA1125 | Drug | AXA1125 administered BID with or without food |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betty Raman, MBBS DPhil FRACP | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37223439 | Derived | Finnigan LEM, Cassar MP, Koziel MJ, Pradines J, Lamlum H, Azer K, Kirby D, Montgomery H, Neubauer S, Valkovic L, Raman B. Efficacy and tolerability of an endogenous metabolic modulator (AXA1125) in fatigue-predominant long COVID: a single-centre, double-blind, randomised controlled phase 2a pilot study. EClinicalMedicine. 2023 May;59:101946. doi: 10.1016/j.eclinm.2023.101946. Epub 2023 Apr 14. |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D018908 | Muscle Weakness |
| D005221 | Fatigue |
| D028361 | Mitochondrial Diseases |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| C000720464 | leucine, isoleucine, valine, arginine, glutamine, and N-acetylcysteine |
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| Placebo |
| Drug |
Matching Placebo administered BID with or without food |
|
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |