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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
• Intervention / Treatment: Drug: AXA1125; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom
    • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AXA1125 33.9g; 33.9 g AXA1125 administered orally BID with or without food	Drug: AXA1125; AXA1125 administered BID with or without food
Placebo Comparator: Placebo; Matching Placebo administered orally BID with or without food	Drug: Placebo; Matching Placebo administered BID with or without food

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Axcella Health, Inc
• Investigators: Principal Investigator: Betty Raman, MBBS DPhil FRACP, Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): June 21, 2022
• Study Completion (Actual): June 29, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Fatigue; COVID; Long COVID; Mitochondrial dysfunction; Skeletal muscle; Bioenergetics; Amino acids; PASC; Muscle weakness; Long-haul COVID; Phosphocreatine recovery; Exertional fatigue; Phospho magnetic resonance spectroscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Fatigue; Infections; Communicable Diseases
• Other Study ID Numbers: AXA1125-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No