Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-01 @ 9:33 AM
Study NCT ID:
NCT04411667
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2020-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C495669', 'term': 'Octagam'}, {'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthew.geriak@sharp.com', 'phone': '8589393717', 'title': 'Matthew Geriak, PharmD / Research Pharmacist', 'organization': 'Sharp HealthCare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '* Study limited to two hospitals in one US city. Resulted in a homogenous population of younger Hispanic/Latino patients.\n* Study was not blinded.\n* Methylprednisolone was used as a pre-medication for each dose of IVIG which may have confounded the results.\n* Small sample size.'}}, 'adverseEventsModule': {'timeFrame': 'from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'eventGroups': [{'id': 'EG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.\n\nOctagam: Standard of Care plus Octagam infusion for 3 days.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 8, 'seriousNumAtRisk': 17, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Elevated D-Dimer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Hypoxic Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Liver Function Tests', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.\n\nOctagam: Standard of Care plus Octagam infusion for 3 days.'}, {'id': 'OG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of subjects requiring mechanical ventilation due to respiratory failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygen Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.\n\nOctagam: Standard of Care plus Octagam infusion for 3 days.'}, {'id': 'OG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}], 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of days requiring oxygen therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'This data was not collected although it was originally intended to be an outcome measure'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.\n\nOctagam: Standard of Care plus Octagam infusion for 3 days.'}, {'id': 'OG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '29'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days', 'description': 'Number of days in hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.\n\nOctagam: Standard of Care plus Octagam infusion for 3 days.'}, {'id': 'FG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.\n\nOctagam: Standard of Care plus Octagam infusion for 3 days.'}, {'id': 'BG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '69'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '80'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '69'}, {'value': '51', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '80'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'groupId': 'BG000', 'lowerLimit': '20.8', 'upperLimit': '49.6'}, {'value': '34.9', 'groupId': 'BG001', 'lowerLimit': '22.7', 'upperLimit': '51.9'}, {'value': '33.6', 'groupId': 'BG002', 'lowerLimit': '20.8', 'upperLimit': '51.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Comorbidities', 'classes': [{'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Chronic kidney disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Coronary artery disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Congestive heart failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asthma/chronic obstructive pulmonary disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Former smoker', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Immunocompromised', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities Continued (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '12.9'}, {'value': '6.4', 'groupId': 'BG001', 'lowerLimit': '4.8', 'upperLimit': '7.3'}, {'value': '8.1', 'groupId': 'BG002', 'lowerLimit': '4.8', 'upperLimit': '12.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% glycosylated hemoglobin', 'dispersionType': 'FULL_RANGE'}, {'title': 'Other Coronavirus Disease 2019 Therapies', 'classes': [{'title': 'Remdesivir', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Convalescent plasma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Glucocorticoids', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-19', 'size': 349320, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-10T17:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-23', 'studyFirstSubmitDate': '2020-05-29', 'resultsFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2020-06-01', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-23', 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical Ventilation', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of subjects requiring mechanical ventilation due to respiratory failure'}], 'secondaryOutcomes': [{'measure': 'Oxygen Therapy', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of days requiring oxygen therapy'}, {'measure': 'Length of Stay', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days', 'description': 'Number of days in hospital'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronavirus', 'IVIG', 'COVID-19'], 'conditions': ['Sars-CoV2']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. The investigator wants to find out if IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune system some help to clear the infection naturally.', 'detailedDescription': 'This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding IVIG to the Standard of Care (SOC) to the SOC without IVIG. Randomization will be 1:1. The goal of this study is to identify whether or not IVIG can halt the progression to respiratory failure requiring mechanical ventilation in subjects admitted to the hospital with confirmed COVID-19. The addition of IVIG to the standard of care treatment for these patients may be beneficial in abating acute lung injury in subjects with SARSCoV-2 induced hypoxia that results in organ injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed COVID-19 positive test result (including presumptive positive).\n* Hospitalization\n* Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not mechanically ventilated\n* Age ≥18 years old.\n* Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.\n* Able to read/write/speak English or Spanish fluently.\n* Subjects must have the capacity to provide consent or an appropriate Legally Authorized Representative (LAR) to provide informed consent.\n\nprovide informed consent, and provide authorization of use and disclosure of personal health information.\n\n* Negative pregnancy test for women of childbearing potential.\n\nExclusion Criteria:\n\n* Severe allergy to any IVIG product formulation\n* History of DVT, PE, thromboembolic stroke or other thrombotic events\n* Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from corn.\n* Uncontrolled hypertension (SBP\\>180 mm Hg or DBP\\>120mmHg)\n* Active participant in another research treatment study\n* Mechanically ventilated patient\n* Code status is Do Not Resuscitate or Do Not Intubate'}, 'identificationModule': {'nctId': 'NCT04411667', 'briefTitle': 'Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection', 'orgStudyIdInfo': {'id': 'COVID-IVIG'}, 'secondaryIdInfos': [{'id': '2004902', 'type': 'OTHER', 'domain': 'Sharp HealthCare Institutional Review Board (SHC IRB)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (study drug+SOC)', 'description': 'Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.', 'interventionNames': ['Drug: Octagam']}, {'type': 'NO_INTERVENTION', 'label': 'Group B (SOC)', 'description': 'Standard of Care'}], 'interventions': [{'name': 'Octagam', 'type': 'DRUG', 'otherNames': ['IVIG'], 'description': 'Standard of Care plus Octagam infusion for 3 days.', 'armGroupLabels': ['Group A (study drug+SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Grossmont Hospital', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'George Sakoulas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharp HealthCare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Sakoulas, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Octapharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Infectious Disease Specialist', 'investigatorFullName': 'George Sakoulas, MD', 'investigatorAffiliation': 'Sharp HealthCare'}}}}