Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-01 @ 6:31 PM
Study NCT ID:
NCT05069532
Status:
UNKNOWN
Last Update Posted:
2021-10-06
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Infection in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of COVID-19 infection in hemodialysis patients.', 'timeFrame': '1 year', 'description': 'radiological and laboratory findings on MSCT chest \\& PCR respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Infection in Hemodialysis Patients']}, 'referencesModule': {'references': [{'pmid': '32467113', 'type': 'BACKGROUND', 'citation': 'Valeri AM, Robbins-Juarez SY, Stevens JS, Ahn W, Rao MK, Radhakrishnan J, Gharavi AG, Mohan S, Husain SA. Presentation and Outcomes of Patients with ESKD and COVID-19. J Am Soc Nephrol. 2020 Jul;31(7):1409-1415. doi: 10.1681/ASN.2020040470. Epub 2020 May 28.'}, {'pmid': '32838082', 'type': 'BACKGROUND', 'citation': 'Tortonese S, Scriabine I, Anjou L, Loens C, Michon A, Benabdelhak M, Ouali S, Morin G, Laifi M, Dobosziewicz H, Guillet M, Dekeyser M, Luong Nguyen LB, Grunenwald A, Dang J, Desbuissons G, Becquemont L, Snanoudj R, Legendre C, Hebibi H, Lefevre E, Beaudreuil S, Zaidan M; AP-HP/Universities/Inserm COVID-19 research collaboration. COVID-19 in Patients on Maintenance Dialysis in the Paris Region. Kidney Int Rep. 2020 Sep;5(9):1535-1544. doi: 10.1016/j.ekir.2020.07.016. Epub 2020 Jul 18.'}, {'pmid': '32444393', 'type': 'BACKGROUND', 'citation': 'Wu J, Li J, Zhu G, Zhang Y, Bi Z, Yu Y, Huang B, Fu S, Tan Y, Sun J, Li X. Clinical Features of Maintenance Hemodialysis Patients with 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. Clin J Am Soc Nephrol. 2020 Aug 7;15(8):1139-1145. doi: 10.2215/CJN.04160320. Epub 2020 May 22.'}, {'pmid': '32207068', 'type': 'BACKGROUND', 'citation': 'Rombola G, Heidempergher M, Pedrini L, Farina M, Aucella F, Messa P, Brunori G. Practical indications for the prevention and management of SARS-CoV-2 in ambulatory dialysis patients: lessons from the first phase of the epidemics in Lombardy. J Nephrol. 2020 Apr;33(2):193-196. doi: 10.1007/s40620-020-00727-y.'}, {'pmid': '32385130', 'type': 'BACKGROUND', 'citation': 'Xiong F, Tang H, Liu L, Tu C, Tian JB, Lei CT, Liu J, Dong JW, Chen WL, Wang XH, Luo D, Shi M, Miao XP, Zhang C. Clinical Characteristics of and Medical Interventions for COVID-19 in Hemodialysis Patients in Wuhan, China. J Am Soc Nephrol. 2020 Jul;31(7):1387-1397. doi: 10.1681/ASN.2020030354. Epub 2020 May 8.'}, {'pmid': '32561681', 'type': 'BACKGROUND', 'citation': 'Corbett RW, Blakey S, Nitsch D, Loucaidou M, McLean A, Duncan N, Ashby DR; West London Renal and Transplant Centre. Epidemiology of COVID-19 in an Urban Dialysis Center. J Am Soc Nephrol. 2020 Aug;31(8):1815-1823. doi: 10.1681/ASN.2020040534. Epub 2020 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'Dialysis patients have a higher risk of infectious complications including complications from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19. There have been several reports describing the effect of CO¬VID-19 in the dialysis population.', 'detailedDescription': "A report of hospitalized COVID-19 patients from Wuhan, China, showed that hemodialysis patients had worse outcomes compared to controls without kidney failure. In addition, the hemodialysis COVID-19 patients developed serious complications such as shock, acute respiratory distress syndrome (ARDS), arrhythmias, and acute cardiac injury at a higher rate. In a population of hospitalized dialysis patients in New York City, there was a 31% mortality rate and 75% of those who required mechanical ventilation died.\n\nThese complications are due to some of their underlying comorbidities and difficulties of keeping adequate social distancing as recommended by CDC guidelines.\n\nWe aim to identify all hemodialysis patients who will be admitted from October 1, 2021 to Septemper 30, 2022. Patients who tested positive for COVID-19 by a polymerase chain reaction (PCR) or highly suspected (CORAD 4-5) according to radiological finding, will be selected and followed until discharge from hospital to determine who will develop complications and who will need ventilatory support. Also, the rate of death will be monitored. Therefore, the current study is aiming to better understand the hemodialysis patients' characteristics profile that makes them susceptible for complications and death."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All hemodialysis patients who defined as patient receiving maintenance dialysis prior to admission and diagnosed with COVID-19 infection either highly suspicious radiological findings (CORAD 4-5) or proved by PCR for COVID-19.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All hemodialysis patients who defined as patient receiving maintenance dialysis prior to admission and diagnosed with COVID-19 infection either highly suspicious radiological findings (CORAD 4-5) or proved by PCR for COVID-19.\n\nExclusion Criteria:\n\n1. ALL Patients diagnosed COVID-19 other than hemodialysis patients.\n2. Hemodialysis patients with chest infection other than COVID-19.'}, 'identificationModule': {'nctId': 'NCT05069532', 'briefTitle': 'COVID-19 Infection in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Incidence of COVID-19 Infection in Hemodialysis Patients and Predictors of Disease Complications and Mortality in Assiut University Hospital Hemodialysis Unit: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'AATHAD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MSCT chest', 'type': 'RADIATION', 'description': 'CORAD 4-5 MSCT chest'}, {'name': 'PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'PCR positive for COVID-19'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmad Bahieldeen Ahmad, MD', 'role': 'CONTACT', 'email': 'Ahmed-bahei@med.aun.edu.eg', 'phone': '01009820300'}, {'name': 'Ashraf Anwar Elshazly, MD', 'role': 'CONTACT', 'phone': '01069176881'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Aboelfatouh Tantawy', 'investigatorAffiliation': 'Assiut University'}}}}