Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 3:45 PM
Study NCT ID:
NCT04438694
Status:
UNKNOWN
Last Update Posted:
2020-09-29
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study is a prospective, single-institution, single-arm, study using a historical control group for comparison. Open label, 2 arms: SOC and SOC+CP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-25', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of hospitalization/Recovery status', 'timeFrame': '2-3 weeks', 'description': 'Decrease of hospital days of safety until discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DONOR', 'RECIPIENT', 'CONVALESCENT PLASMA'], 'conditions': ['COVID19']}, 'descriptionModule': {'briefSummary': '* This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases.\n* This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank.\n\nThe concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection.\n\nAn informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP).\n\nOther data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).', 'detailedDescription': 'This study will be done inside Cairo university hospitals, it will involve a number of CP donors who were recovered from COVID-19 infection and were treated at Cairo University isolation hospital. The CP donation process will take place at CUH blood bank ,the number of the donors will be determined at the end of the study as it will vary according to the donation process .\n\nThe study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have laboratory confirmed COVID-19 and admitted to Cairo University isolation hospital.\n* Admitted to acute care facility.\n* Must have severe or immediately life-threatening COVID-19:\n\nSevere disease is defined as:\n\n* dyspnea,\n* respiratory frequency ≥ 30/min,\n* blood oxygen saturation ≤ 93%,\n* partial pressure of arterial oxygen to fraction of inspired oxygen ratio \\<300, and/or\n* lung infiltrates \\> 50% within 24 to 48 hours (CT finding)\n\nLife-threatening disease is defined as:\n\n* respiratory failure,\n* septic shock, and/or\n* multiple organ dysfunction or failure\n\nExclusion Criteria:\n\n* Pregnancy\n* Autoimmune disorder\n* Participated in a CP trial in the past 6 months'}, 'identificationModule': {'nctId': 'NCT04438694', 'acronym': 'CP IN COVID19', 'briefTitle': 'Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection', 'orgStudyIdInfo': {'id': 'N39-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'STANDARD OF COARE', 'description': 'Receiving SOC', 'interventionNames': ['Drug: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'STANDARD CP DOSE Adm (Two infusions)', 'description': 'Two infusions 48 hours apart', 'interventionNames': ['Biological: Convalescent Plasma', 'Drug: Standard of Care']}], 'interventions': [{'name': 'Convalescent Plasma', 'type': 'BIOLOGICAL', 'description': 'Convalescent Plasma', 'armGroupLabels': ['STANDARD CP DOSE Adm (Two infusions)']}, {'name': 'Standard of Care', 'type': 'DRUG', 'description': 'Standard of Care drugs administered as per Cairo University ICU protocol', 'armGroupLabels': ['STANDARD CP DOSE Adm (Two infusions)', 'STANDARD OF COARE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa ElShazly, MD PhD', 'role': 'CONTACT'}, {'name': 'Omar Fahmy, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Akram AbdelBarry, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yasser Nassar, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Heba Sharaf, Md PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Azza AboulEnin, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ashraf ElFiky, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed Mokhtar, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Taghreed Gaafar, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nevine S El Shakhs, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cairo University Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Nermeen ElDesouky, MD PhD', 'role': 'CONTACT', 'email': 'nermeen.eldesoukey@kasralainy.edu.eg', 'phone': '01006029006'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR OF CLINICAL PATHOLOGY', 'investigatorFullName': 'Nermeen El Desouky', 'investigatorAffiliation': 'Cairo University'}}}}