MedTrace Logo

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

NCT05152849 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-10-20

No results posted yet for this study

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

DRUG

AXA1125

AXA1125 administered BID with or without food

DRUG

Placebo

Matching Placebo administered BID with or without food

Sponsors & Collaborators

  • Axcella Health, Inc

    lead INDUSTRY

Principal Investigators

  • Betty Raman, MBBS DPhil FRACP · Oxford University Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2022-06-21
Completion
2022-06-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05152849 on ClinicalTrials.gov