Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 10:51 AM
Study NCT ID:
NCT04987606
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2021-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post COVID-19 Interstitial Lung Disease: A Study of Genetic and Environmental Interactions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-30', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in the bacterial burden and composition of the respiratory microbiome in post covid fibrosis compared to health', 'timeFrame': '2 years', 'description': 'The lower airway bacterial burden and microbiome will be characterised in patients with post covid fibrosis and compared to that of health.'}], 'secondaryOutcomes': [{'measure': 'Change in bacterial burden over time in post covid fibrosis', 'timeFrame': '2 years', 'description': 'Differences in the airway bacterial burden at baseline and one year following covid-19 infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Fibrosis', 'COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'This study aims to understand why some people who have had COVID-19 develop scarring of the lungs and why some people recover more quickly than others.', 'detailedDescription': 'A large number of people diagnosed with COVID-19 suffer from long term symptoms, predominantly breathlessness and fatigue whether or not they were admitted to hospital. While there are a number of causes of long-term breathlessness following COVID-19 one of the most common, and potentially concerning with regards to long term prognosis is Interstitial Lung Disease.\n\nThe fibrogenic potential of SARS-CoV-2 is currently unknown but is predicted to be substantial based on the experience of previous coronavirus outbreaks and emerging data from this pandemic.\n\nThe investigators do not yet understand how scarring occurs following SARS-CoV-2, nor why there is resolution in some individuals and persistent or progressive disease in others. The investigators therefore plan to undertake bronchoscopy (camera test into the lungs) to examine for changes in the way the cells lining the lung behave, using genetics, and differences in the bacteria living in the airways in patients whom have developed scarring following COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with interstitial lung disease following COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evidence of SARS-CoV-2 PCR/Seropositive\n* Presence of interstitial lung disease on CT\n* Participant is willing and able to give informed consent for participation in the study\n* Aged 18 years or above\n\nExclusion Criteria:\n\n* Confirmed ILD diagnosis prior to March 2020\n* Patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study.\n* Use of steroids at baseline visit'}, 'identificationModule': {'nctId': 'NCT04987606', 'acronym': 'POSTCODE', 'briefTitle': 'Post COVID-19 Interstitial Lung Disease: A Study of Genetic and Environmental Interactions', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'POST COvid-19 Interstitial Lung DiseasE (POSTCODE) A Study of Genetic and Environmental Interactions: an Observational Cohort Study.', 'orgStudyIdInfo': {'id': '21SM6765'}}, 'contactsLocationsModule': {'locations': [{'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6NP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1BL', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}