Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-27 @ 6:14 PM
Study NCT ID:
NCT04935450
Status:
UNKNOWN
Last Update Posted:
2021-06-23
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Inflammation in COVID-19 ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Bronchoalveolar Lavage Fluid samples Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-08-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-21', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital Mortality', 'timeFrame': 'Up to 3 months', 'description': 'Mortality in hospital'}, {'measure': 'Health related quality of life via SF-36 questionnaire', 'timeFrame': 'Up to 3 months'}], 'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Up to 3 months', 'description': 'Correlation of BALF and Blood mediators with ICU mortality'}], 'secondaryOutcomes': [{'measure': 'Respiratory mechanics', 'timeFrame': 'Day 0 (after study inclusion) and every day up to 3 months', 'description': 'Correlation of BALF and Blood mediators with respiratory mechanics during invasive mechanical ventilation'}, {'measure': 'BALF PCR', 'timeFrame': 'Day 0 (performance of first BALF sample) Day 8, Day 16', 'description': 'Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid, comparison with contemporary PCR in Blood'}, {'measure': 'BALF characteristics', 'timeFrame': 'Day 0 (performance of first BALF sample) Day 8, Day 16', 'description': 'Cellular populations in BALF and their change over time'}, {'measure': 'BALF cytoquines', 'timeFrame': 'Day 0 (performance of first BALF sample) Day 8, Day 16', 'description': 'Cytoquines in BALF and change over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'COVID-19', 'Broncho Alveolar Lavage', 'Pulmonary Inflammation', 'Mechanical Ventilation', 'Respiratory Mechanics'], 'conditions': ['ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2', 'COVID-19 Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients older than 18 years of age, with COVID-19 related ARDS (C-ARDS) hospitalized in the ICU and invasively mechanically ventilated will be included in the study.\n\nThis is an observational cohort study. After informed consent by the next of kin, and within the first 72 hours of invasive mechanical ventilation a blood and a Broncho Alveolar Lavage Fluid (BALF) sample will be collected. If the patients remain invasively mechanically ventilated a second and third blood and BALF sample will be collected every 7-10 days.', 'detailedDescription': 'The main objective of the core study is to measure a number of biochemical, cellular and inflammatory mediators in the BALF of C-ARDS patients and evaluate their correlation with the course of disease in terms of respiratory mechanics, complications and outcomes.\n\nThe mediators selected have been previously used in ARDS investigation to attempt prognostic and predictive enrichment.\n\nPatients hospitalized in the ICU following C-ARDS and requiring invasive mechanical ventilation will be candidates for enrollment.\n\nPatients enrolled in the study (Informed consent obtained from next of kin) will be subject to the realization of optic bronchoscopy within the first 72 h of mechanical ventilation to obtain BALF for analysis. A second and third bronchoscopy and sampling of BALF will be performed every 7-10 days if mechanical ventilation and the clinical conditions allow it. A sample of whole blood will be taken contemporary to each bronchoscopy in order to perform parallel measurements (lungs and peripheral blood). Patients will be followed up until hospital discharge.\n\nBALF samples will be divided to perform different analysis in the immunology, cytology and microbiology labs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 ARDS ICU patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* COVID-19 related ARDS\n* Hospitalized in ICU\n* Invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Immunocompromised for previous condition\n* transplanted patients\n* Known pulmonary bacterial co-infection at the time of admission to the ICU\n* Contraindication to the realization of Bronchoscopy (Itracranial Hypertension, severe hypoxaemia with P/F \\< 80, severe hemodynamic instability, severe arrhythmia, non correctable coagulopathy)'}, 'identificationModule': {'nctId': 'NCT04935450', 'acronym': 'IMPU-COVID', 'briefTitle': 'Pulmonary Inflammation in COVID-19 ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Pulmonary Inflammation Profiles in COVID-19 Related ARDS', 'orgStudyIdInfo': {'id': '398-20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bronchoalveolar lavage', 'type': 'DIAGNOSTIC_TEST', 'description': 'Low volume Broncho alveolar lavage. During optic flexible bronchoscopy through the tracheal tube or the tracheostomy cannula a maximum of 4 aliquots of 20 ml normal saline will be instilled in a wedged position in the right medium lobe of the patients and then aspirated untill reaching a total of 25ml of fluid (BALF) for analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28020', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'TOMMASO BARDI, MD', 'role': 'CONTACT', 'email': 'tommaso.bardi@gmail.com', 'phone': '+34640350484'}], 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'TOMMASO BARDI, MD', 'role': 'CONTACT', 'email': 'tommaso.bardi@gmail.com', 'phone': '+34640350484'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tommaso Bardi', 'investigatorAffiliation': 'Hospital Universitario Ramon y Cajal'}}}}