Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT04442958
Status:
COMPLETED
Last Update Posted:
2020-07-01
First Post:
2020-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Convalescent Immune Plasma Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma ferritin level', 'timeFrame': '7. day', 'description': 'Acute phase reactant'}, {'measure': 'Lymphocyte count', 'timeFrame': '7. day', 'description': 'Infection markers'}, {'measure': 'D-Dimer level', 'timeFrame': '7. day', 'description': 'Hypercoagulability'}, {'measure': 'C-Reactive protein level', 'timeFrame': '7. day', 'description': 'Infection markers'}, {'measure': 'Plasma procalcitonin level', 'timeFrame': '7. day', 'description': 'Infection markers'}, {'measure': 'Plasma fibrinogen level', 'timeFrame': '7. day', 'description': 'Coagulopathy'}], 'secondaryOutcomes': [{'measure': 'Fractional Inspired Oxygen Level', 'timeFrame': '7. day', 'description': 'Arterial oxygenation'}, {'measure': 'Partial Oxygen Saturation level', 'timeFrame': '7. day', 'description': 'Arterial oxygenation'}, {'measure': 'Arterial Oxygen level', 'timeFrame': '7. day', 'description': 'Arterial oxygenation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the safety, improvement of clinical symptoms and laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients with ARDS.', 'detailedDescription': 'The aim of the study is to evaluate the safety, improvement of clinical symptoms with hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma treatment in severe Covid-19 patients followed up in critical care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Clinical diagnosis of Covid-19\n\nExclusion Criteria Age lower than 18 Lower plasma IgA levels PaO2/FiO2 higher than 300 mmHg SpO2 higher than 90'}, 'identificationModule': {'nctId': 'NCT04442958', 'briefTitle': 'Effectiveness of Convalescent Immune Plasma Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bagcilar Training and Research Hospital'}, 'officialTitle': 'Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': '2020.05.2.14.070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Convalescent Plasma Therapy Group', 'description': 'One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.', 'interventionNames': ['Other: Convalescent Immune Plasma']}, {'type': 'NO_INTERVENTION', 'label': 'Non-Plasma Therapy Group', 'description': 'Standart critical care treatment group'}], 'interventions': [{'name': 'Convalescent Immune Plasma', 'type': 'OTHER', 'description': 'One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.', 'armGroupLabels': ['Convalescent Plasma Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34375', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Bagcılar Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Salih SS Sevdi, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Bagcılar Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bagcilar Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}