Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04652518
Status:
TERMINATED
Last Update Posted:
2024-02-14
First Post:
2020-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LYT-100 in Post-acute COVID-19 Respiratory Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093844', 'term': 'pirfenidone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'whyStopped': 'Part A of the study was completed; Part B of the study was terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'dispFirstSubmitDate': '2023-06-28', 'completionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-02', 'dispFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in distance walked on the six-minute walk test (6MWT)', 'timeFrame': 'Baseline to Day 91', 'description': 'The 6MWT is a validated endpoint commonly used in clinical trial research'}], 'secondaryOutcomes': [{'measure': 'Change in Dyspnoea-12 score', 'timeFrame': 'Baseline to Day 91', '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.'}, {'measure': 'Change in Saint George Respiratory Questionnaire-I (SGRQ-I) score', 'timeFrame': 'Baseline to Day 91', '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.'}, {'measure': 'Change in Modified Borg Dyspnoea Scale (mBDS) score', 'timeFrame': 'Baseline to Day 91', '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.'}, {'measure': 'Quality of Life assessment as collected using the SF-36', 'timeFrame': 'Baseline to Day 91', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Covid19', 'Post-acute COVID-19 Respiratory Disease']}, 'referencesModule': {'references': [{'pmid': '40692836', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* 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)\n* 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\n* COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan) with a minimum of two lung lobes involvement\n* Able to bear weight and ambulate a minimum of 10 m distance (use of inhaled oxygen permitted)\n* 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\n\nKey Exclusion Criteria:\n\n* 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.\n* 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\n* Unstable angina or myocardial infarction in the last month prior to screening\n* Patients on MV, ECMO, NIV, and/or HFNO within the last 72 hours prior to screening"}, 'identificationModule': {'nctId': 'NCT04652518', 'briefTitle': 'LYT-100 in Post-acute COVID-19 Respiratory Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'PureTech'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LYT-100-2020-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LYT-100', 'description': 'LYT-100 taken orally twice a day (BID) for 91 days', 'interventionNames': ['Drug: LYT-100']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matching LYT-100 taken orally BID for 91 days', 'interventionNames': ['Other: Placebo']}, {'type': 'OTHER', 'label': 'Open Label Extension LYT-100', 'description': '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.', 'interventionNames': ['Drug: LYT-100']}], 'interventions': [{'name': 'LYT-100', 'type': 'DRUG', 'otherNames': ['Deupirfenidone'], 'description': 'oral administration', 'armGroupLabels': ['LYT-100', 'Open Label Extension LYT-100']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35630', 'city': 'Florence', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Alabama Medical Center', 'geoPoint': {'lat': 34.79981, 'lon': -87.67725}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California - Keck School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Vista Health Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Central Florida Pulmonary Group', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33704', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Pulmonary and Critical Care', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Center for Advanced Research and Education', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '60805', 'city': 'Evergreen Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'GenHarp Clinical Solutions', 'geoPoint': {'lat': 41.72059, 'lon': -87.70172}}, {'zip': '10941', 'city': 'Middletown', 'state': 'New York', 'country': 'United States', 'facility': 'Circuit Clinical/Crystal Run Healthcare LLP', 'geoPoint': {'lat': 41.44593, 'lon': -74.42293}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Southeastern Research Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburg Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Affinity Health Corp', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Frostwood Family Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Sciences Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '8336', 'city': 'Villa Regina', 'state': 'Río Negro Province', 'country': 'Argentina', 'facility': 'Clinica Central S.A', 'geoPoint': {'lat': -39.09631, 'lon': -67.08374}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Fundacion Estudios Clinicos', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Investigaciones en Patologias Respiratorias', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '80030-110', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'CETI - Centro de Estudos em Terapias Inovadoras', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '21941-913', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto de Doencas do Torax', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'PMSI Republican Clinical Hospital "T. 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