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

NCT05152849 | Completed Phase 2

• 1 other identifier: AXA1125-201
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Long COVID; Long-haul COVID; Muscle weakness; COVID; PASC; Fatigue; Amino acids; Bioenergetics; Mitochondrial dysfunction; Phosphocreatine recovery; Exertional fatigue; Phospho magnetic resonance spectroscopy; Skeletal muscle

Outcome Measures

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)

  Baseline to 28 days

Secondary Outcomes (9)

• 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

Study Arms (2)

AXA1125 33.9g

EXPERIMENTAL

33.9 g AXA1125 administered orally BID with or without food

Drug: AXA1125

Placebo

PLACEBO COMPARATOR

Matching Placebo administered orally BID with or without food

Drug: Placebo

Interventions

AXA1125 DRUG

AXA1125 administered BID with or without food

AXA1125 33.9g

Placebo DRUG

Matching Placebo administered BID with or without food

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Axcella Health, Inc: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37223439 DERIVED

MeSH Terms

Conditions

Infections; Post-Acute COVID-19 Syndrome; Muscle Weakness; Fatigue; Mitochondrial Diseases

Interventions

leucine, isoleucine, valine, arginine, glutamine, and N-acetylcysteine

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Betty Raman, MBBS DPhil FRACP

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: December 15, 2021
• Primary Completion: June 21, 2022
• Study Completion: June 29, 2022
• Last Updated: October 20, 2022

Record last verified: 2021-11

Locations

GB (1)