Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04505605
Status:
TERMINATED
Last Update Posted:
2022-01-18
First Post:
2020-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of a Possible Respiratory Degradation Prognosis Caused by Biomarkers in Severe Forms of COVID-19 Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples on a dry tube with 5mL separating gel are collected, depending on patient hospitalization procedure.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The PI decided to stop the study due to the low number of inclusions.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-30', 'studyFirstSubmitDate': '2020-07-31', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the dosage of biomarkers', 'timeFrame': '6 months = study duration', 'description': 'The study aims at evaluating the interests of the biomarkers dosage: endotoxin (LPS) and circulating cytokines (HMGB1 or RAGE) in the prediction of respiratory degradation through a severe form of COVID-19 acquired pneumonia that requires a hospitalization.'}], 'secondaryOutcomes': [{'measure': 'Link between the biomarkers', 'timeFrame': '6 months = study duration', 'description': 'The study will be also focusing on the search for a correlation between the biomarkers by blood samples that will be taken on each hospitalized patients.'}]}, 'conditionsModule': {'keywords': ['covid19', 'pneumonia', 'community acquired pneumonia', 'biomarkers'], 'conditions': ['Community-acquired Pneumonia', 'Covid19']}, 'descriptionModule': {'briefSummary': 'Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe forms, it may require a mechanical ventilation or even lead to an acute respiratory distress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lower than that of previous strains, particularly MERS-CoV (Middle East Respiratory Syndrome), its spread is considerably bigger. As a result, the number of patients developing respiratory distress that require an invasive mechanical ventilation is high, with prolonged ventilation duration in these situations.', 'detailedDescription': 'The mechanisms responsible for alveolar damage during viral pathologies, particularly Coronavirus, are very similar to those observed during acute respiratory distress syndromes in adults. Macrophages present in the pulmonary parenchyma appear to play a central role in the severity of the inflammatory response and the production of proinflammatory mediators, notably chemokines leading to secondary leukocyte infiltration. The recent monocytic origin could explain the particular severity of this inflammatory response whose usual control is no longer assured. The alteration of infectious control by alveolar macrophages during ageing also tends to confirm the central role of these cells in the pattern of respiratory distress observed during COVID-19 infection, which is particularly severe in the elderly.\n\nIn many situations, the endotoxin (or lipopolysaccharide, LPS) plays a major role in the pathophysiology and even the severity of respiratory damage, in particular, due to the existence of circulating endotoxin from the pathogenic agent responsible (Gram-negative bacteria), but also due to translocation of digestive origin in the context of sepsis (systemic inflammatory response) which is associated with (if not responsible for) respiratory aggression. Such an alteration of the mucous membrane is particularly noticeable in cases of obesity. The importance of this mechanism during pulmonary aggression of viral origin is, on the other hand, unknown.\n\nFew data are available on the prediction of early onset of respiratory distress syndrome in low respiratory infection in the absence of mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient aged from 18 years, infected by the COVID-19 and suffers from a severe form of COVID 19 acquired pneumonia that requires an hospitalization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged from 18 years old\n* French-speaking patient\n* Patient whose COVID-19 respiratory infection was confirmed by laboratory tests (either by a PCR and any other commercial or public health tests) or a scanner, that requires a hospitalization in a healthcare institution.\n\nExclusion Criteria:\n\n* Patient/ relative or proxy person opposed to the study participation\n* Patient under guardianship or curators\n* Patient deprived of liberty\n* Patient under the safeguard of justice.\n* Dying / Moribund patient\n* Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT04505605', 'acronym': 'LPSARS2', 'briefTitle': 'Study of a Possible Respiratory Degradation Prognosis Caused by Biomarkers in Severe Forms of COVID-19 Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Study of a Possible Respiratory Degradation Prognosis Caused by Biomarkers in Severe Forms of COVID-19 Pneumonia: the LPSARS2 Study', 'orgStudyIdInfo': {'id': 'LPSARS2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient hospitalized without being transferred in the ICU', 'description': 'A blood sample on a dry tube with 5 ml separating gel in addition to the blood test made on the basis of the usual medical care, will be taken on D1 (day of the enrollment = the day of hospitalization in the healthcare institution). The total volume of blood collected as part of the research is therefore 5 ml.', 'interventionNames': ['Other: Blood samples']}, {'label': 'Patient directly hospitalized in the ICU', 'description': 'A blood sample on a dry tube with a 5 ml separating gel in addition to the blood test made on the basis of the usual medical care, will be taken on D1 and D3 of the admission to intensive care. The total volume of blood collected for research is therefore 10 ml.', 'interventionNames': ['Other: Blood samples']}, {'label': 'Patient transferred from an other hospital service to the ICU', 'description': "A blood sample on a dry tube with 5 ml separating gel in addition to the blood test that will be taken at D1 and D3 of the patient's admission to the intensive care unit, even if it has already been included in the study during the patient's admission to the unit (D1 hospitalization). The total volume of blood collected for the research is therefore 15 ml.", 'interventionNames': ['Other: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'OTHER', 'description': 'A blood sample will be collected on a dry tube with 5mL separating gel on each enrolled patients. Those will be made depending on the patients hospitalization.', 'armGroupLabels': ['Patient directly hospitalized in the ICU', 'Patient hospitalized without being transferred in the ICU', 'Patient transferred from an other hospital service to the ICU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95107', 'city': 'Argenteuil', 'country': 'France', 'facility': 'Centre Hospitalier Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'François PHILIPPART, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Victor Dupouy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}