Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-02-07 @ 11:44 PM
Study NCT ID:
NCT04532632
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2020-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taste and Smell Impairment in Critically Ill COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D013651', 'term': 'Taste Disorders'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000086582', 'term': 'Anosmia'}, {'id': 'D004408', 'term': 'Dysgeusia'}], 'ancestors': [{'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': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '10 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-07', 'studyFirstSubmitDate': '2020-08-28', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'taste and smell impairment', 'timeFrame': 'up to 3 months', 'description': 'incidence of taste and smell impairment in critically ill subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronavirus disease-19', 'anosmia', 'hyposmia', 'dysgeusia'], 'conditions': ['Smell Disorder', 'Taste Disorders', 'Coronavirus Infection']}, 'referencesModule': {'references': [{'pmid': '32366299', 'type': 'BACKGROUND', 'citation': 'Hopkins C, Surda P, Whitehead E, Kumar BN. Early recovery following new onset anosmia during the COVID-19 pandemic - an observational cohort study. J Otolaryngol Head Neck Surg. 2020 May 4;49(1):26. doi: 10.1186/s40463-020-00423-8.'}, {'pmid': '32513096', 'type': 'BACKGROUND', 'citation': 'Sayin I, Yasar KK, Yazici ZM. Taste and Smell Impairment in COVID-19: An AAO-HNS Anosmia Reporting Tool-Based Comparative Study. Otolaryngol Head Neck Surg. 2020 Sep;163(3):473-479. doi: 10.1177/0194599820931820. Epub 2020 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study', 'detailedDescription': 'Patients who were treated in the intensive care unit of Şişli Hamidiye Etfal Training and Research Hospital with the diagnosis of Coronavirus disease-19 will be determined by scanning the hospital registry system. It was planned that patients discharged from the intensive care unit would be called by phone and their complaints about smell and taste disorders were evaluated with a questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the ages of 18-80, who were treated in the intensive care unit with the diagnosis of Coronavirus disease-19 and were discharged', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between the ages of 18-80\n* Agree to participate in the study\n* Patients treated in the intensive care unit with the diagnosis of Coronavirus disease-19\n\nExclusion Criteria:\n\n* Pre-existing smell and taste impairment\n* The patients have no enough cooperation to answer the questionnaire\n* Having additional diseases such as dementia and Alzheimer'}, 'identificationModule': {'nctId': 'NCT04532632', 'briefTitle': 'Taste and Smell Impairment in Critically Ill COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'Taste and Smell Impairment in Critically Ill COVID-19 Patients', 'orgStudyIdInfo': {'id': '3334-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '34371', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sisli Etfal Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pinar Ay Sayin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'specialist medical doctor', 'investigatorFullName': 'Pinar Ay Sayin', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}