This study is being conducted in two parts, A and B. Part A is a randomized, double-blind, parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in adults with post-acute COVID-19 respiratory complications. Part B is an Open Label Extension (OLE) study for patients who complete Part A.
Part A of this study is a randomized, double-blind, parallel arm study being conducted at approximately 35 centers globally to evaluate the safety and efficacy of LYT-100 compared to placebo in 168 adults with post-acute COVID-19 respiratory complications who were treated with mechanical ventilation, extracorporeal membrane oxygenation, non-invasive ventilation (eg CPAP or BiPAP), high-flow nasal oxygen therapy or any other means of oxygen administration in the hospital for at least 1 day and have required only low flow nasal oxygen or no oxygen supplementation for at least 72 hours prior to screening. LYT-100 or placebo will be taken daily for up to 91 days with the primary outcome of change in distance walked on the six-minute walk test performed in line with the American Thoracic Society Respiratory Society Guidelines assessed at Day 91. Secondary endpoints, including pharmacokinetics, inflammatory biomarkers, imaging, and patient-reported outcomes of dyspnea and the 36-Item Short Form Health Survey will also be evaluated. The second part of the study, Part B, is an open-label extension in which eligible patients who completed Part A will be enrolled and treated with open-label LYT-100 for an additional 91 days. The primary endpoint for Part B of the study is to assess the longer-term safety, tolerability, and efficacy of LYT-100 through up to 182 days of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
185
Change From Baseline in Distance Walked During the Six-Minute Walk Test (6MWT)
The 6MWT is a validated endpoint commonly used in clinical trial research. The 6MWT measures the distance a subject can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated response of all the systems involved during exercise.
Time frame: Baseline to Day 91
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University of Alabama at Birmingham
Birmingham, Alabama, United States
North Alabama Medical Center
Florence, Alabama, United States
University of Southern California - Keck School of Medicine
Los Angeles, California, United States
Vista Health Research
Miami, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Coastal Pulmonary and Critical Care
St. Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Center for Advanced Research and Education
Gainesville, Georgia, United States
GenHarp Clinical Solutions
Evergreen Park, Illinois, United States
Circuit Clinical/Crystal Run Healthcare LLP
Middletown, New York, United States
...and 21 more locations