Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-31 @ 8:36 AM
Study NCT ID:
NCT04473157
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2020-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 in Patients With Anosmia in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086582', 'term': 'Anosmia'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D004408', 'term': 'Dysgeusia'}], 'ancestors': [{'id': 'D000857', 'term': 'Olfaction 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': '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Nasopharyngeal and oropharyngeal Swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery from Anosmia', 'timeFrame': '3 weeks', 'description': 'subjective questionnaire about smell and taste'}, {'measure': 'Seroconversion', 'timeFrame': '3 weeks', 'description': 'developing IgM/ IgG antibodies by rapid test'}], 'secondaryOutcomes': [{'measure': 'COVID 19', 'timeFrame': '3 weeks', 'description': 'developing other symptoms of COVID 19'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corona virus', 'SARS-CoV-2', 'Olfactory Disturbance', 'Taste Disturbance'], 'conditions': ['Anosmia', 'Covid19', 'Dysgeusia']}, 'referencesModule': {'references': [{'pmid': '32301284', 'type': 'BACKGROUND', 'citation': 'Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18.'}, {'pmid': '32320008', 'type': 'BACKGROUND', 'citation': 'Spinato G, Fabbris C, Polesel J, Cazzador D, Borsetto D, Hopkins C, Boscolo-Rizzo P. Alterations in Smell or Taste in Mildly Symptomatic Outpatients With SARS-CoV-2 Infection. JAMA. 2020 May 26;323(20):2089-2090. doi: 10.1001/jama.2020.6771.'}, {'pmid': '32393804', 'type': 'BACKGROUND', 'citation': 'Menni C, Valdes AM, Freidin MB, Sudre CH, Nguyen LH, Drew DA, Ganesh S, Varsavsky T, Cardoso MJ, El-Sayed Moustafa JS, Visconti A, Hysi P, Bowyer RCE, Mangino M, Falchi M, Wolf J, Ourselin S, Chan AT, Steves CJ, Spector TD. Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med. 2020 Jul;26(7):1037-1040. doi: 10.1038/s41591-020-0916-2. Epub 2020 May 11.'}, {'pmid': '24619619', 'type': 'BACKGROUND', 'citation': 'Desforges M, Le Coupanec A, Brison E, Meessen-Pinard M, Talbot PJ. Neuroinvasive and neurotropic human respiratory coronaviruses: potential neurovirulent agents in humans. Adv Exp Med Biol. 2014;807:75-96. doi: 10.1007/978-81-322-1777-0_6.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to test the frequency of severe acute respiratory syndrome new corona virus SARS-CoV-2 or other respiratory viruses in patients presenting with anosmia or dysgeusia to Ain Shams University Hospitals, Cairo, Egypt.', 'detailedDescription': 'Fifty Patients presenting to Triage and/or Ear, Nose and Throat (ENT) clinics in Ain Shams University Hospitals with the chief complaint of Anosmia/ dysgeusia in the period July- September 2020; will undergo thorough history taking, clinical assessment and polymers chain reaction rt-PCR to SARS-COV2; and if proven negative to COVID 19, PCR to other respiratory pathogens will be tested. COVID-19 patients will be managed according to the standard protocol of Ain Shams University Hospitals. Follow up after 3 weeks for the outcome of recovery of the smell sense and seroconversion by rapid test for immunoglobulins IgM/ IgG of COVID 19, for the probability of a false negative PCR at initial visit.\n\nEthical committee approval for the current study protocol was obtained. Patients will be invited to participate and the informed consent will be signed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fifty Patients presenting to Triage and/or ENT clinics in Ain Shams University Hospitals with the chief complaint of Anosmia/ dysgeusia in the period July- August 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult (\\>18 years) patients presented with acute-onset anosmia.\n\nExclusion Criteria:\n\n* patients with anosmia or gustatory dysfunctions before the epidemic; patients with previous history of chronic sinusitis or previous sinus surgery.'}, 'identificationModule': {'nctId': 'NCT04473157', 'briefTitle': 'COVID-19 in Patients With Anosmia in Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Detection of SARS-CoV-2 in Patients Presenting With Anosmia During COVID-19 Pandemic Era in Egypt', 'orgStudyIdInfo': {'id': 'FMASU P45a/2020'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ossama I Mansour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Otolaryngology', 'investigatorFullName': 'Ossama Mansour, MD, FACS', 'investigatorAffiliation': 'Ain Shams University'}}}}