Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-04 @ 11:45 PM
Study NCT ID:
NCT05455892
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mortality, Gravity Predictive Factors and Clinical Evolution of Older COVID-19 Patients in Short Geriatric Services.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In hospital mortality rate.', 'timeFrame': 'During patient hospitalization, an average of 10 days.', 'description': 'Observed mortality rate will be presented with its 95% confidence interval.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ELDERLY', 'COVID-19'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Since the beginning of the year 2020, clinical characteristics of a new disease as the global COVID-19 epidemic has spread in France. People over 70 years of age are the more concerned by this virus in proportion and in gravity with some atypical first symptoms compared to younger patients. Evolution of the disease is variable from forms with few symptoms to severe forms sometimes quickly lethal.\n\nGERICOVID LYON is a descriptive analysis of all patients over 70 years of age hospitalised for COVID-19 in short geriatric unities of University Hospital of Lyon This study will allow more comprehension about COVID-19 in older people. The role of predictive factors, pre-existing comorbidities and the nature and frequency of complications in a short period will be investigate. Treatments practices will be analysed too.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study was proposed to all patients over 70 years of age, with a positive Polymerase Chain Reaction or a high presumption of COVID-19, hospitalized in short geriatric units in University Hospital of Lyon between 1er March 2020 and 30th June 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 70 years of age.\n* Patient hospitalized in short geriatric units in University Hospital of Lyon.\n* Patient diagnosed with COVID-19 (positive Polymerase Chain Reaction or a high presumption of COVID-19 based on clinical and/or scannographic evidence).\n* Patient Informed and non-opposed to the research (Patient informed of the study by his medical doctor during hospitalization or by post, thanks to a generic information sheet dedicated to COVID-19 researches).\n\nExclusion Criteria:\n\n* Patient opposed to the research.'}, 'identificationModule': {'nctId': 'NCT05455892', 'acronym': 'GERICOVID', 'briefTitle': 'Mortality, Gravity Predictive Factors and Clinical Evolution of Older COVID-19 Patients in Short Geriatric Services.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Analysis of Mortality, Gravity Predictive Factors and Evolution of Clinical Characteristics of Older Patients Hospitalized for COVID-19 in Short Geriatric Services.', 'orgStudyIdInfo': {'id': 'AGORA n°36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elder patients hospitalized for COVID-19 in geriatric short stay units.', 'description': 'All patients over 70 years of age, with a positive Polymerase Chain Reaction or a high presumption of COVID-19, hospitalized in short geriatric units in University Hospital of Lyon, who agree with retrospective collection of their clinical datas.', 'interventionNames': ['Other: Clinical data collection during hospitalization in short geriatric units.']}], 'interventions': [{'name': 'Clinical data collection during hospitalization in short geriatric units.', 'type': 'OTHER', 'description': 'Retrospective clinical data collection, at time of infection and 10 days later. Correlation between mortality and gravity. Identification of predictive mortality factors such as frailty, preexisting comorbidities, complications and treatments. Description of medical prescription evolutions.', 'armGroupLabels': ['Elder patients hospitalized for COVID-19 in geriatric short stay units.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69300', 'city': 'Caluire-et-Cuire', 'state': 'Rhone', 'country': 'France', 'facility': "Service de gériatrie aigue de l'hôpital de la Croix Rousse. Hospices Civils de Lyon", 'geoPoint': {'lat': 45.79462, 'lon': 4.8464}}, {'zip': '69003', 'city': 'Lyon', 'state': 'Rhone', 'country': 'France', 'facility': "Service de gériatrie aigue de l'hôpital Edouard Herriot, Pavillon T. Hospices Civils de Lyon", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69003', 'city': 'Lyon', 'state': 'Rhone', 'country': 'France', 'facility': "Service de gériatrie aigue de l'hôpital Edouard Herriot. Hospices Civils de Lyon", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'state': 'Rhone', 'country': 'France', 'facility': "Service de gériatrie aigue de l'hôpital Lyon Sud. Hospices Civils de Lyon", 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69100', 'city': 'Villeurbanne', 'state': 'Rhone', 'country': 'France', 'facility': "Service de gériatrie aigue de l'hôpital des Charpennes. Hospices Civils de Lyon", 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}