Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT04427358
Status:
COMPLETED
Last Update Posted:
2020-11-25
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population
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': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-20', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Analysis of the rate of RT-PCR SARS-CoV-2 positive at 1 month of COVID infection', 'timeFrame': 'at 1 month of COVID infection]'}, {'measure': '2. Assess quantitative evaluation of a nasopharyngeal swab SARS-CoV-2 RT-PCR test', 'timeFrame': 'at 1 month after COVID infection', 'description': 'The objective of this study is to quantitatively assess viral shedding in COVID-19 infected elderly patients who survived infection in order to provide an overview of the evolution of nasopharyngeal swab SARS-CoV-2 real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test results with the Cycle threshold value of the RT-PCR test.. The investigatrors analyze nasopharyngeal RT-PCR at diagnosis. After one month since the date of onset symptoms they reassessed survival patients with nasopharyngeal RT-PCR and repeat the RT-PCR at least every week until final negative conversion occurs.'}], 'secondaryOutcomes': [{'measure': 'Assessment of late stool SARS-CoV-2 RT-PCR, serological status and associated factors with death and RT-PCR results 1 month after the date of first symptom onset', 'timeFrame': '1 month after the date of first symptom onset', 'description': '* Assessment of late stool SARS-CoV-2 RT-PCR results one month after the date of onset symptom(dso) (% of patients with a positive fecal RT-PCR test after 1 month)\n* COVID-19 serological status; associated factors with death and RT-PCR results 1 month after the dso: Age (year), gender, Medical history prior to hospilization : Hypertension, diabetes, coronary artery disease, heart failure, atrial fibrillation, chronic respiratory disease, History of medication: ACEI, ARBs Antiplatetet drug, doses of anticoagulant therapy, antibiotic, corticotherapy, statin, Proton pump inhibitor, T°C\\>37.8 7 days after the onset of symptoms, weight in kg, height in meter combined to report BMI in kg/m\\^2, Charlson score, Use of adjuvant oxygen, Lung CT-Scan results : extent of lesion \\<25%/25-50%/50-75%/\\>75%, Lymphocytes, platelet, CRP count at the time of diagnosis and 7 days after, GFR at diagnosis ml/min /1.73m2, ABO group, Rhesus antibody, Nasopharyngeal RT PCR initial Cycle Threshold'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RT-PCR SARS-CoV-2', 'Covid-19', 'Carriage', 'Viral shredding', 'Elderly', 'Elderly people', 'Geriatric'], 'conditions': ['Covid-19']}, 'descriptionModule': {'briefSummary': 'Evaluation of the rate of positive RT-PCR SARS-CoV-2 test at 1 month of COVID infection among elderly people.\n\nIt is unclear how long an individual with COVID-19 will remain "sick" and "contagious". It appears that SARS-CoV-2 can be transmitted before symptoms appear and throughout the course of the disease.\n\nThey investigators did not find any study on a COVID + geriatric population reassessing carriage at 1 month even though age seems to be a risk factor for prolonged excretion as suggested in the study following study: Xu K, Chen Y, Yuan J, Yi P, Ding C, Wu W, et al. Factors associated with prolonged viral RNA shedding in patients with COVID-19. Clinical Infectious Diseases. 2020 Apr 9; ciaa351'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient over 70 years age having COVID-19', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 70years\n* Patient hospitalized on the geriatric center from March 1, 2020 to August 1, 2020 with a diagnosis of COVID-19 still alive at 1 month.\n* Patient having agreed to the re-use of their data for the purposes of this research\n\nExclusion Criteria:\n\n* Subject who expressed his opposition to participate in the study\n* Subject under judicial protection'}, 'identificationModule': {'nctId': 'NCT04427358', 'acronym': 'COVID-19GAOM', 'briefTitle': 'RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population', 'orgStudyIdInfo': {'id': '7838'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service SSR Gériatrique', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}