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

Axcella Health

Status and phase

Completed

Phase 2

Conditions

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

Treatments

Drug: Placebo

Drug: AXA1125

Study type

Interventional

Funder types

Industry

Identifiers

NCT05152849

AXA1125-201

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No 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