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

Sponsor

Axcella Health, Inc (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05152849

Collaborator

(none)

Enrollment

Location

Arms

5.7

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection	Drug: AXA1125 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 10, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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

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

Outcome Measures

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) [Baseline to 28 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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