Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-04 @ 6:33 PM
Study NCT ID:
NCT04402905
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2020-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study in Diagnosed Patients COVID-19, Supported on an Outpatient Basis. (COVID-PSL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2020-05-25', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-PSL Cohort', 'timeFrame': '3 months', 'description': 'measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Infection']}, 'descriptionModule': {'briefSummary': 'COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in China at the end of 2019, and which has since spread around the world, responsible for a new major pandemic, which is upsetting the whole world.\n\nIf severe respiratory disease is the form that constitutes the extreme gravity of the disease (mortality, with more than 170,000 deaths worldwide to date).\n\nHowever, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic pauci forms, moderate forms, up to severe forms.\n\nDifferent symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms, anosmia and / or ageusia, skin involvement, etc.\n\nGiven the novelty of this infection, several questions remain:\n\n* What are all the symptoms that can be contracted by a COVID-19 patient?\n* Are there clinical forms not described?\n* What is the evolutionary profile, the healing time of this disease in patients treated on an outpatient basis?\n* What are the factors associated with a prolonged form of COVID-19 disease, including on an outpatient basis?', 'detailedDescription': 'Most of the descriptive studies relating to COVID-19 relate to the severe forms of the disease managed in the hospital sector.\n\nFew data have been published on moderate forms, requiring no hospitalization, of strict outpatient management.\n\nThese so-called moderate forms, however, constitute the majority of cases of COVID-19 (approximately 80%).\n\nIn the Infectious and Tropical Diseases Department of Pitie Salpetriere, COVIDOM pilot site, at the beginning of March, during the intensification of the epidemic in France, a weekly telephone consultation was set up to take care of people tested for COVID + by PCR, or people not tested by PCR, or even tested with negative PCR but symptomatic and followed at home, suffering from moderate form of COVID-19, as well as their contact cases if they wished.\n\nTelemedicine is particularly suitable in this epidemic context, ensuring continuity of care, while limiting face-to-face consultations, thus reducing the risk of cross-contamination.\n\nGiven the novelty of this infection, it is important to be able to best characterize these ambulatory forms, as well as their evolution, in order to manage these patients, and to offer primary care physicians a more detailed description of these forms. , which they are and will be called upon to take care of, general medicine being central to dealing with the epidemic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Enrolment will be done from the active queue of patients included in the COVIDOM / PSL platform.\n\nThis study will be a monocentric data collection. The patient is called, on working days, weekly from D0 to D30, and beyond if the symptoms persist on D30.\n\nData will be collected at D0, D7, D14, D21 and D30. The visit on D30 corresponds to the end of the systematic weekly telephone interviews if the patient has reached complete recovery, defined by the absence of symptoms for 3 days.\n\nIf the symptoms persist on D30: monitoring is continued, on D45 and D60, and beyond if necessary.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* COVID PCR + patient: Patient screened positive by PCR on nasopharyngeal swab\n* or COVID-like patient: Patient not screened, but considered COVID + because contact with a COVID PCR + person, and presenting symptoms suggestive of COVID-19 among:\n* Influenza-like illness (fever, body aches, arthralgia, etc.)\n* Respiratory form: dyspnea, cough, rhinitis\n* Gastrointestinal form: diarrhea, nausea, vomiting\n* Anosmia and / or ageusia\n* or patient COVID PCR-: If patient tested negative by PCR on nasopharyngeal swab, but showing signs suggestive of COVID-19.\n\nExclusion Criteria:\n\n* Patient objecting to the use of their data for research purposes\n* Patient under justice or deprived of liberty.'}, 'identificationModule': {'nctId': 'NCT04402905', 'acronym': 'COVID-PSL', 'briefTitle': 'Observational Study in Diagnosed Patients COVID-19, Supported on an Outpatient Basis. (COVID-PSL)', 'organization': {'class': 'OTHER', 'fullName': "Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida"}, 'officialTitle': 'Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.', 'orgStudyIdInfo': {'id': 'CREPATS 011'}}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Yasmine Dudoit', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Christine Katlama, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pitie-Salpetriere Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}