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

Phase 2

Completed

• Conditions: Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
• Interventions: Drug: AXA1125; Drug: Placebo

• Registration Number: NCT05152849
• Lead Sponsor: Axcella Health, Inc

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-10
• Study Start: 2021-12-15
• Primary Completion: 2022-06-21
• Study Completion: 2022-06-29
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXA1125 33.9g	AXA1125	33.9 g AXA1125 administered orally BID with or without food
Placebo	Placebo	Matching Placebo administered orally BID with or without food

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Proportion of subjects with a decrease in venous serum lactate level from baseline 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 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
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

Trial Locations

Locations (1)

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom