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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
AXA1125
Placebo
Sponsored by
Axcella Health, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection focused on measuring 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

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oxford University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXA1125 33.9g

Placebo

Arm Description

33.9 g AXA1125 administered orally BID with or without food

Matching Placebo administered orally BID with or without food

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS)
Proportion of subjects with improvement in PCr recovery rate
Change from baseline in serum lactate level after a 6-minute walk test
Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT
Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT
Change from baseline in distance traveled during a 6MWT
Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11
Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 before and after a 6MWT
Proportion of subjects with an improvement in fatigue score as assessed by CFQ-11 before and after a 6MWT

Full Information

First Posted
November 29, 2021
Last Updated
October 18, 2022
Sponsor
Axcella Health, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05152849
Brief Title
Efficacy, Safety, Tolerability of AXA1125 in Fatigue After COVID-19 Infection
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axcella Health, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXA1125 33.9g
Arm Type
Experimental
Arm Description
33.9 g AXA1125 administered orally BID with or without food
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo administered orally BID with or without food
Intervention Type
Drug
Intervention Name(s)
AXA1125
Intervention Description
AXA1125 administered BID with or without food
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo administered BID with or without food
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS)
Time Frame
Baseline to 28 days
Title
Proportion of subjects with improvement in PCr recovery rate
Time Frame
Baseline to 28 days
Title
Change from baseline in serum lactate level after a 6-minute walk test
Time Frame
Baseline to 28 days
Title
Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT
Time Frame
Baseline to 28 days
Title
Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT
Time Frame
Baseline to 28 days
Title
Change from baseline in distance traveled during a 6MWT
Time Frame
Baseline to 28 days
Title
Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11
Time Frame
Baseline to14 days
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Raman, MBBS DPhil FRACP
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

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

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