LYT-100 in Post-acute COVID-19 Respiratory Disease

NCT ID: NCT04652518

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-11
• Study Completion Date: 2022-07-18

Brief Summary

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.

Detailed Description

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.

Conditions

Covid19; Post-acute COVID-19 Respiratory Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LYT-100

LYT-100 taken orally twice a day (BID) for 91 days

Group Type: EXPERIMENTAL

LYT-100

Intervention Type: DRUG

oral administration

Placebo

Placebo matching LYT-100 taken orally BID for 91 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

oral administration

Open Label Extension LYT-100

Open Label Extension: LYT-100 taken orally BID for 91 days The Open Label Extension (Part B) was terminated after results of the Double Blind Portion.

Group Type: OTHER

LYT-100

Intervention Type: DRUG

oral administration

Interventions

LYT-100

oral administration

Intervention Type: DRUG

Placebo

oral administration

Intervention Type: OTHER

Other Intervention Names

Deupirfenidone

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinipace Worldwide

INDUSTRY

Sponsor Role: collaborator

Novotech (Australia) Pty Limited

INDUSTRY

Sponsor Role: collaborator

PureTech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toby Maher, MD

Role: PRINCIPAL_INVESTIGATOR

Keck School of Medicine, University of Southern California

Locations

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

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, Río Negro Province, Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, Paraná, 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

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

Timișoara, , 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

Countries

United States; Argentina; Brazil; Moldova; Philippines; Romania; Ukraine; United Kingdom

References

Kulkarni T, Santiaguel J, Aul R, Harnett M, Krop J, Chen MC, Graham CS, Maher TM. Deupirfenidone (LYT-100) in post-acute sequelae of SARS-CoV-2 with respiratory complications. ERJ Open Res. 2025 Jul 21;11(4):01142-2024. doi: 10.1183/23120541.01142-2024. eCollection 2025 Jul.

Reference Type: DERIVED

PMID: 40692836 (View on PubMed)

Other Identifiers

LYT-100-2020-02

Identifier Type: -

Identifier Source: org_study_id