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.
Drug: LYT-100
oral administration
Other Name: Deupirfenidone
Other: Placebo
oral administration
Key Inclusion Criteria:
- Positive result of a molecular RT-qPCR diagnostic test or SARS-CoV-2 RNA result from a
clinical specimen deemed clinically associated with the current episode of illness,
warranting hospital admission as per investigator's judgement, or previously
hospitalized (central and/or local laboratory COVID-19 test results are accepted from
any biological material source)
- Hospitalization for COVID-19 respiratory disease and treated with supplemental oxygen
(including MV, ECMO or any other means of oxygen administration) in hospital for at
least 1 day
- COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan) with a minimum of two
lung lobes involvement
- Able to bear weight and ambulate a minimum of 10 m distance (use of inhaled oxygen
permitted)
- Shortness of breath ≥ grade 3 on mBDS dyspnea scale and not requiring MV, ECMO, NIV,
and/or HFNO (nasal O2 is allowed) for at least 72 hours before screening
Key Exclusion Criteria:
- Pre-existing chronic respiratory condition(s), obstructive or restrictive, for which
the patient is actively taking concomitant medication are excluded. Patients with
history of Idiopathic Pulmonary Fibrosis (IPF), lung cancer, pulmonary arterial
hypertension, other interstitial lung diseases, severe cardiac insufficiency (grade
IV) are excluded irrespective of whether they are actively being medicated for those
conditions or not.
- Pre-existing co-morbid conditions preventing outcome assessments, e.g., neurological,
medical, orthopedic injury/disability, disease or condition that would prevent ability
to transfer and walk for 6 minutes, prior to confirmed COVID-19 diagnosis
- Unstable angina or myocardial infarction in the last month prior to screening
- Patients on MV, ECMO, NIV, and/or HFNO within the last 72 hours prior to screening
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
Saint 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
Southeastern Research Center
Winston-Salem, North Carolina, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States
Affinity Health Corp
Nashville, Tennessee, United States
Frostwood Family Medicine
Houston, Texas, United States
The University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
Clinica Central S.A
Villa Regina, Rio Negro, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe, Argentina
Investigaciones en Patologias Respiratorias
San Miguel De Tucumán, Tucuman, Argentina
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, Parana, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
Instituto de Doencas do Torax
Rio De Janeiro, Brazil
PMSI Republican Clinical Hospital "T. Mosneaga"
Chisinau, Moldova, Republic of
University of the Philippines Manila - Philippine General Hospital (PGH)
Manila, Philippines
Quirino Memorial Medical Center (QMMC)
Quezon City, Philippines
National Institute for Infectious Diseases "Prof. Dr. Matei Balş" (Arensia Eploratory Medicine)
Bucharest, Romania
Spitalul Clinic De Pneumoftiziologie "Leon Daniello" Cluj-Napoca
Cluj-Napoca, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova
Craiova, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes - Timisoara
Timişoara, Romania
Medical Center of Limited Liability Company "Harmoniya krasy"
Kiev, Ukraine
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, United Kingdom
St George's University Hospitals NHS Foundation Trust - St George's Hospital
London, United Kingdom
Toby Maher, MD, Principal Investigator
Keck School of Medicine, University of Southern California