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Completed

NCT Number: NCT05152849

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

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Key information

Conditions

Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Fatigue Infections Lung Diseases Metabolic Diseases Mitochondrial Diseases Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nidovirales Infections Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AXA1125

Drug

AXA1125 administered BID with or without food

Placebo

Drug

Matching Placebo administered BID with or without food

Primary outcomes

  1. Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS)

    Time frame: Baseline to 28 days

Secondary outcomes

  1. Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS)

    Time frame: Baseline to 28 days

  2. Proportion of subjects with improvement in PCr recovery rate

    Time frame: Baseline to 28 days

  3. Change from baseline in serum lactate level after a 6-minute walk test

    Time frame: Baseline to 28 days

  4. Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT

    Time frame: Baseline to 28 days

  5. Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT

    Time frame: Baseline to 28 days

  6. Change from baseline in distance traveled during a 6MWT

    Time frame: Baseline to 28 days

  7. Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11

    Time frame: Baseline to14 days

  8. Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 before and after a 6MWT

    Time frame: Baseline to 28 days

  9. Proportion of subjects with an improvement in fatigue score as assessed by CFQ-11 before and after a 6MWT

    Time frame: Baseline to 28 days

Sponsors and collaborators

Lead sponsor

Axcella Health, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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