NCT05152849

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Axcella Health, Inc · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	AXA1125	AXA1125 administered BID with or without food
DRUG	Placebo	Matching Placebo administered BID with or without food

Timeline

• Start date: 2021-12-15
• Primary completion: 2022-06-21
• Completion: 2022-06-29
• First posted: 2021-12-10
• Last updated: 2022-10-20

Locations

1 site across 1 country: United Kingdom