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

NCT04652518 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: LYT-100-2020-02
• Study Type: interventional
• Target: 185
• Locations: 8 countries
• Sites: 31

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.

Conditions

Covid19; Post-acute COVID-19 Respiratory Disease

Keywords

COVID-19 Respiratory Disease; novel coronavirus; respiratory complications; SARS-CoV-2; post acute; lung fibrosis; interstitial lung disease; long COVID; long haul COVID; Post-acute COVID-19 Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• Change in distance walked on the six-minute walk test (6MWT)

  The 6MWT is a validated endpoint commonly used in clinical trial research

  Baseline to Day 91

Secondary Outcomes (4)

• Change in Dyspnoea-12 score

  Baseline to Day 91

• Change in Saint George Respiratory Questionnaire-I (SGRQ-I) score

  Baseline to Day 91

• Change in Modified Borg Dyspnoea Scale (mBDS) score

  Baseline to Day 91

• Quality of Life assessment as collected using the SF-36

  Baseline to Day 91

Study Arms (3)

LYT-100

EXPERIMENTAL

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

Drug: LYT-100

Placebo

PLACEBO COMPARATOR

Placebo matching LYT-100 taken orally BID for 91 days

Other: Placebo

Open Label Extension LYT-100

OTHER

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.

Drug: LYT-100

Interventions

LYT-100 DRUG

oral administration

Also known as: Deupirfenidone

LYT-100; Open Label Extension LYT-100

Placebo OTHER

oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PureTech: lead
• Clinipace Worldwide: collaborator
• Novotech (Australia) Pty Limited: collaborator

Study Sites (31)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

North Alabama Medical Center

Florence, Alabama, 35630, United States

Location

University of Southern California - Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Vista Health Research

Miami, Florida, 33176, United States

Location

Central Florida Pulmonary Group

Orlando, Florida, 32803, United States

Location

Coastal Pulmonary and Critical Care

St. Petersburg, Florida, 33704, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Center for Advanced Research and Education

Gainesville, Georgia, 30501, United States

Location

GenHarp Clinical Solutions

Evergreen Park, Illinois, 60805, United States

Location

Circuit Clinical/Crystal Run Healthcare LLP

Middletown, New York, 10941, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Affinity Health Corp

Nashville, Tennessee, 37203, United States

Location

Frostwood Family Medicine

Houston, Texas, 77024, United States

Location

The University of Texas Health Sciences Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Clinica Central S.A

Villa Regina, Río Negro Province, 8336, Argentina

Location

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, Paraná, 80030-110, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Instituto de Doencas do Torax

Rio de Janeiro, 21941-913, Brazil

Location

PMSI Republican Clinical Hospital "T. Mosneaga"

Chisinau, 2025, Moldova

Location

University of the Philippines Manila - Philippine General Hospital (PGH)

Manila, 1000, Philippines

Location

Quirino Memorial Medical Center (QMMC)

Quezon City, 1109, Philippines

Location

National Institute for Infectious Diseases "Prof. Dr. Matei Balş" (Arensia Eploratory Medicine)

Bucharest, Romania

Location

Spitalul Clinic De Pneumoftiziologie "Leon Daniello" Cluj-Napoca

Cluj-Napoca, 400332, Romania

Location

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova

Craiova, 200515, Romania

Location

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes - Timisoara

Timișoara, 300310, Romania

Location

Medical Center of Limited Liability Company "Harmoniya krasy"

Kiev, 01135, Ukraine

Location

Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

London, SE1 9RT, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust - St George's Hospital

London, SW17 0QT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40692836 DERIVED

MeSH Terms

Conditions

COVID-19; Pulmonary Fibrosis; Lung Diseases, Interstitial; Post-Acute COVID-19 Syndrome

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Post-Infectious Disorders; Chronic Disease; Disease Attributes

Study Officials

• Toby Maher, MD

  Keck School of Medicine, University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 3, 2020
• Study Start: December 11, 2020
• Primary Completion: June 28, 2022
• Study Completion: July 18, 2022
• Last Updated: February 14, 2024

Record last verified: 2023-10

Locations

AR (3); PH (2); UA (1); US (15); MO (1); GB (2); BR (3); RO (4)