Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT04456556
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Endophthalmitis and Orbital Cellulitis in Patients With Novel Coronavirus Disease (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009877', 'term': 'Endophthalmitis'}, {'id': 'D054517', 'term': 'Orbital Cellulitis'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D002481', 'term': 'Cellulitis'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract 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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-01', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined Endophthalmitis and Orbital Cellulitis in patients with Novel Coronavirus Disease (COVID-19)', 'timeFrame': 'baseline', 'description': 'highlight the occurrence of combined endophthalmitis and orbital cellulitis in patients with novel Coronavirus Disease (COVID-19)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endophthalmitis', 'orbital cellulitis', 'covid-19'], 'conditions': ['Endophthalmitis and Orbital Cellulitis']}, 'referencesModule': {'references': [{'pmid': '32265202', 'type': 'BACKGROUND', 'citation': 'Chen L, Liu M, Zhang Z, Qiao K, Huang T, Chen M, Xin N, Huang Z, Liu L, Zhang G, Wang J. Ocular manifestations of a hospitalised patient with confirmed 2019 novel coronavirus disease. Br J Ophthalmol. 2020 Jun;104(6):748-751. doi: 10.1136/bjophthalmol-2020-316304. Epub 2020 Apr 7.'}, {'pmid': '32419568', 'type': 'BACKGROUND', 'citation': 'Turbin RE, Wawrzusin PJ, Sakla NM, Traba CM, Wong KG, Mirani N, Eloy JA, Nimchinsky EA. Orbital cellulitis, sinusitis and intracranial abnormalities in two adolescents with COVID-19. Orbit. 2020 Aug;39(4):305-310. doi: 10.1080/01676830.2020.1768560. Epub 2020 May 18.'}, {'pmid': '28275981', 'type': 'BACKGROUND', 'citation': 'Elshafei AMK, Sayed MF, Abdallah RMA. Clinical profile and outcomes of management of orbital cellulitis in Upper Egypt. J Ophthalmic Inflamm Infect. 2017 Dec;7(1):8. doi: 10.1186/s12348-017-0126-3. Epub 2017 Mar 9.'}, {'pmid': '34523045', 'type': 'DERIVED', 'citation': 'Abdelkader MFSO, Elshafei AMK, Nassar MM, Abu Elela MA, Abdallah RMA. Combined endophthalmitis and orbital cellulitis in patients with corona virus disease (COVID-19). J Ophthalmic Inflamm Infect. 2021 Sep 15;11(1):27. doi: 10.1186/s12348-021-00258-y.'}]}, 'descriptionModule': {'briefSummary': 'To report on cases presented with combined endophthalmitis and orbital cellulitis as a first presentation of covid-19 infection.', 'detailedDescription': 'This observation case series study included 5 patients referred to the Ophthalmology Department, Minia University with severe ophthalmic manifestations in the form of combined endophthalmitis and orbital cellulitis. On doing the work-up of covid-19 infection according to the recommendations of Egyptian Ministry of Health, patients proved to be infected by the novel Corona virus. In addition to the Corona work-up, all patients were subjected to full ophthalmological evaluation, ocular ultrasound and orbital CT examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '5 patients referred to the Ophthalmology Department, Minia University with severe ophthalmic manifestations in the form of combined endophthalmitis and orbital cellulitis. On doing the work-up of covid-19 infection according to the recommendations of Egyptian Ministry of Health, patients proved to be infected by the novel Corona virus.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with endophthalmitis and orbital cellulitis with covid-19\n\nExclusion Criteria:\n\n* Patients without endophthalmitis and orbital cellulitis.\n* Patients with endophthalmitis and orbital cellulitis not having covid-19 infection.'}, 'identificationModule': {'nctId': 'NCT04456556', 'briefTitle': 'Combined Endophthalmitis and Orbital Cellulitis in Patients With Novel Coronavirus Disease (COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Combined Endophthalmitis and Orbital Cellulitis in Patients With Novel Coronavirus Disease (COVID-19)', 'orgStudyIdInfo': {'id': 'ocular infection in covid19'}}, 'contactsLocationsModule': {'locations': [{'zip': '61519', 'city': 'Minya', 'state': 'Minya Governorate', 'country': 'Egypt', 'facility': 'Minia university Hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Mohamed Farouk Sayed Othman Abelkader', 'investigatorAffiliation': 'Minia University'}}}}