* Efficacy, Safety, and Tolerability of AXA1125 in PASC
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
Axcella Health, Inc.
Duration of Study in the UK
0 years, 5 months, 4 days
An estimated 10% of Coronavirus Disease 2019 (COVID-19) survivors continue to experience symptoms several weeks to months after the appearance of initial symptoms, a condition termed post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC). Common symptoms of PASC infection can include but are not limited to, extreme tiredness (fatigue), shortness of breath, chest pain, problems with memory and concentration, joint pain, loss of smell and headache. Currently there are no approved treatments for PASC.
AXA1125-201 is a randomised, double-blind, placebo-controlled pilot study designed to evaluate the efficacy, safety and tolerability of AXA1125 in subjects with fatigue Predominant PASC (>12 weeks after initial infection). Approximately 40 eligible subjects (approximately 20 subjects per arm) will be randomised in a 1:1 ratio to receive twice-daily (BID) oral administration of 33.9 g AXA1125 or a placebo.
AXA1125 is an orally active mixture of 5 specific amino acids (AAs) (leucine, isoleucine, valine, arginine, and glutamine) and N-acetyl-L-cysteine (an AA derivative). AXA1125 (33.9 g BID) has the potential to alleviate fatigue in subjects with PASC compared to placebo. Supplementation of AAs has been reported to improve fatigue and muscle weakness and is thought to improve PASC-fatigue via the modification of various cellular processes, including the way the body processes energy.
This study will comprise a Screening Period of up to 4 weeks, a Treatment Period of 4 weeks, and a Follow-up Period of 1 week. The total study duration for each subject will be approximately 9 weeks. Participants will have clinic visits on Day 1 and Day 28, as well as telephone visits on Day 14 and 1 week after completion of study product administration.
Approximately 40 eligible subjects will be enrolled at 1 site in the United Kingdom. The study is being sponsored by Axcella Health, Inc.
Yorkshire & The Humber - Leeds East Research Ethics Committee
Date of REC Opinion
5 Nov 2021
Further Information Favourable Opinion