Back to resultsLYT-100 in Post-acute COVID-19 Respiratory Disease
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LYT-100
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID-19 Respiratory Disease, novel coronavirus, respiratory complications, SARS-CoV-2, post acute, lung fibrosis, interstitial lung disease, long COVID, long haul COVID
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham
- North Alabama Medical Center
- University of Southern California - Keck School of Medicine
- Vista Health Research
- Central Florida Pulmonary Group
- Coastal Pulmonary and Critical Care
- Tampa General Hospital
- Center for Advanced Research and Education
- GenHarp Clinical Solutions
- Circuit Clinical/Crystal Run Healthcare LLP
- Southeastern Research Center
- University of Pittsburg Medical Center
- Affinity Health Corp
- Frostwood Family Medicine
- The University of Texas Health Sciences Center at San Antonio
- Clinica Central S.A
- Fundacion Estudios Clinicos
- Investigaciones en Patologias Respiratorias
- CETI - Centro de Estudos em Terapias Inovadoras
- Hospital de Clinicas de Porto Alegre
- Instituto de Doencas do Torax
- PMSI Republican Clinical Hospital "T. Mosneaga"
- University of the Philippines Manila - Philippine General Hospital (PGH)
- Quirino Memorial Medical Center (QMMC)
- National Institute for Infectious Diseases "Prof. Dr. Matei Balş" (Arensia Eploratory Medicine)
- Spitalul Clinic De Pneumoftiziologie "Leon Daniello" Cluj-Napoca
- Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova
- Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes - Timisoara
- Medical Center of Limited Liability Company "Harmoniya krasy"
- Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
- St George's University Hospitals NHS Foundation Trust - St George's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LYT-100
Placebo
Arm Description
LYT-100 taken orally BID for 91 days
Placebo matching LYT-100 taken orally BID for 91 days
Outcomes
Primary Outcome Measures
Change in distance walked on the six-minute walk test (6MWT)
The 6MWT is a validated endpoint commonly used in clinical trial research
Secondary Outcome Measures
Change in Dyspnoea-12 score
Dyspnoea-12 measures "breathlessness severity" without reference to current activity and was developed for use in interstitial lung disease and COPD current experience ("these days.") The tool generates a total score using 12 descriptor items including seven physical and five affective items with response options none (0), mild (1), moderate (2) or severe (3). The total score ranges from 1 to 36 whereby the higher score correlates with greater breathlessness severity.
Change in Saint George Respiratory Questionnaire-I (SGRQ-I) score
Saint George Respiratory Questionnaire-I (SGRQ-I) is an idiopathic pulmonary fibrosis disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with interstitial lung disease. There are 34 self-completed items with 3 domain component scores (Symptoms, Activities, and Impacts), with higher scores indicating more limitations.
Change in Modified Borg Dyspnoea Scale (mBDS) score
The mBDS is an assessment tool that analyzes breathlessness under exertion. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal.
Quality of Life assessment as collected using the SF-36
The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being and overall evaluation of health in 8 domains.
Full Information
NCT ID
NCT04652518
First Posted
December 2, 2020
Last Updated
February 27, 2023
Sponsor
PureTech
Collaborators
Clinipace Worldwide, Novotech (Australia) Pty Limited
1. Study Identification
Unique Protocol Identification Number
NCT04652518
Brief Title
LYT-100 in Post-acute COVID-19 Respiratory Disease
Official Title
A Phase 2 Randomized, Double-blind, Placebo-controlled Trial and Open Label Extension to Evaluate the Safety and Efficacy of Deupirfenidone (LYT-100) in Post-acute COVID-19 Respiratory Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PureTech
Collaborators
Clinipace Worldwide, Novotech (Australia) Pty Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19 Respiratory Disease, novel coronavirus, respiratory complications, SARS-CoV-2, post acute, lung fibrosis, interstitial lung disease, long COVID, long haul COVID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LYT-100
Arm Type
Experimental
Arm Description
LYT-100 taken orally BID for 91 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching LYT-100 taken orally BID for 91 days
Intervention Type
Drug
Intervention Name(s)
LYT-100
Other Intervention Name(s)
Deupirfenidone
Intervention Description
oral administration
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Change in distance walked on the six-minute walk test (6MWT)
Description
The 6MWT is a validated endpoint commonly used in clinical trial research
Time Frame
Baseline to Day 91
Secondary Outcome Measure Information:
Title
Change in Dyspnoea-12 score
Description
Dyspnoea-12 measures "breathlessness severity" without reference to current activity and was developed for use in interstitial lung disease and COPD current experience ("these days.") The tool generates a total score using 12 descriptor items including seven physical and five affective items with response options none (0), mild (1), moderate (2) or severe (3). The total score ranges from 1 to 36 whereby the higher score correlates with greater breathlessness severity.
Time Frame
Baseline to Day 91
Title
Change in Saint George Respiratory Questionnaire-I (SGRQ-I) score
Description
Saint George Respiratory Questionnaire-I (SGRQ-I) is an idiopathic pulmonary fibrosis disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with interstitial lung disease. There are 34 self-completed items with 3 domain component scores (Symptoms, Activities, and Impacts), with higher scores indicating more limitations.
Time Frame
Baseline to Day 91
Title
Change in Modified Borg Dyspnoea Scale (mBDS) score
Description
The mBDS is an assessment tool that analyzes breathlessness under exertion. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal.
Time Frame
Baseline to Day 91
Title
Quality of Life assessment as collected using the SF-36
Description
The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being and overall evaluation of health in 8 domains.
Time Frame
Baseline to Day 91
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toby Maher, MD
Organizational Affiliation
Keck School of Medicine, University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
North Alabama Medical Center
City
Florence
State/Province
Alabama
ZIP/Postal Code
35630
Country
United States
Facility Name
University of Southern California - Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Vista Health Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Central Florida Pulmonary Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Coastal Pulmonary and Critical Care
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33704
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Center for Advanced Research and Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
GenHarp Clinical Solutions
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Circuit Clinical/Crystal Run Healthcare LLP
City
Middletown
State/Province
New York
ZIP/Postal Code
10941
Country
United States
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Pittsburg Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Affinity Health Corp
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Frostwood Family Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
The University of Texas Health Sciences Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinica Central S.A
City
Villa Regina
State/Province
Rio Negro
ZIP/Postal Code
8336
Country
Argentina
Facility Name
Fundacion Estudios Clinicos
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Investigaciones en Patologias Respiratorias
City
San Miguel De Tucumán
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
CETI - Centro de Estudos em Terapias Inovadoras
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Instituto de Doencas do Torax
City
Rio De Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
PMSI Republican Clinical Hospital "T. Mosneaga"
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
University of the Philippines Manila - Philippine General Hospital (PGH)
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Quirino Memorial Medical Center (QMMC)
City
Quezon City
ZIP/Postal Code
1109
Country
Philippines
Facility Name
National Institute for Infectious Diseases "Prof. Dr. Matei Balş" (Arensia Eploratory Medicine)
City
Bucharest
Country
Romania
Facility Name
Spitalul Clinic De Pneumoftiziologie "Leon Daniello" Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400332
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova
City
Craiova
ZIP/Postal Code
200515
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes - Timisoara
City
Timişoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Medical Center of Limited Liability Company "Harmoniya krasy"
City
Kiev
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St George's University Hospitals NHS Foundation Trust - St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
LYT-100 in Post-acute COVID-19 Respiratory Disease
We'll reach out to this number within 24 hrs