Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-01 @ 10:55 AM
Study NCT ID:
NCT04681157
Status:
UNKNOWN
Last Update Posted:
2020-12-28
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study on Anosmias and Ageusias Linked to Infection by Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D004408', 'term': 'Dysgeusia'}, {'id': 'D000086582', 'term': 'Anosmia'}, {'id': 'D000370', 'term': 'Ageusia'}], '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'}, {'id': 'D013651', 'term': 'Taste Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-04-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-23', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective analysis of demographic and clinical characteristics of patients with suspected or already confirmed SARS-Cov2 infection with anosmia and / or ageusia', 'timeFrame': 'The files analysed retrospectily from February 01, 2020 to June 03, 2020 will be examined]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Odor disturbance', 'Taste disturbances', 'SARS-Cov2', 'Anosmia', 'Ageusia'], 'conditions': ['Covid-19']}, 'descriptionModule': {'briefSummary': 'Odor and taste disturbances have increased dramatically during this time of the COVID-19 pandemic. Currently, we have very little information on the demographic and clinical characteristics of the affected population, on the severity and course of the olfactory / taste loss.\n\nThe main objective of this research is to analyze the epidemiological, demographic and clinical characteristics of patients suspected or already confirmed of infection with SARS-Cov2 presenting with anosmia and / or ageusia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major subject (≥18 years old)\n* Subject having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19\n* Subject with suspected or confirmed Covid-19 infection\n* Subject taken care of by the ENT service\n* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.\n\nExclusion Criteria:\n\n* Subject having expressed opposition to participating in the study\n* Subject under guardianship or guardianship\n* Subject under safeguard of justice'}, 'identificationModule': {'nctId': 'NCT04681157', 'acronym': 'STras-Cov-2', 'briefTitle': 'Retrospective Study on Anosmias and Ageusias Linked to Infection by Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Retrospective Study on Anosmias and Ageusias Linked to Infection by SARS-Cov 2', 'orgStudyIdInfo': {'id': '7754'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'state': 'Starsbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion RENAUD, MD', 'role': 'CONTACT', 'email': 'marion.renaud@chru-strasbourg.fr', 'phone': '33 3 88 12 61 89'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}, {'name': 'Marion RENAUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christian DEBRY, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François LEFEBVRE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guillaume TRAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra LEON, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Strasbourg University Hospitals - Otorhino-Laryngology Department', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Marion RENAUD, MD', 'role': 'CONTACT', 'email': 'marion.renaud@chru-strasbourg.fr', 'phone': '33 3 88 12 61 89'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}