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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2022-06-29

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AXA1125 33.9g

33.9 g AXA1125 administered orally BID with or without food

Group Type EXPERIMENTAL

AXA1125

Intervention Type DRUG

AXA1125 administered BID with or without food

Placebo

Matching Placebo administered orally BID with or without food

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo administered BID with or without food

Interventions

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AXA1125

AXA1125 administered BID with or without food

Intervention Type DRUG

Placebo

Matching Placebo administered BID with or without food

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No