Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT04513158
Status:
TERMINATED
Last Update Posted:
2024-10-24
First Post:
2020-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joseph.flynn@nortonhealthcare.org', 'phone': '502-272-5001', 'title': 'Joseph M. Flynn, DO, MPH', 'organization': 'Norton Healthcare'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Data was not collected or analyzed. Trial was stopped early because other therapy options became more readily available and the majority of room air patients were being discharged from the ED making finding eligible patients more difficult.'}}, 'adverseEventsModule': {'timeFrame': 'Data was not collected or analyzed.', 'description': 'Data was not collected or analyzed.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'timeFrame': 'Through study completion, an average of 30 days', 'description': 'Measured by respiratory rate \\>30/min, blood oxygen saturation \\<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \\<300 and received a medical diagnosis of respiratory failure, septic shock or multiple', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'Determine the Immunologic Effects of Convalescent Plasma Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'SARS-CoV-2 Ag levels through RT-PCR', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Lymphocyte Count (10*3/uL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'Reatinine Kinase (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein (mg/dl)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'D-Dimer (ng/ml FEU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'Interleukin-6 (pg/ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'Ferritin (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'This study was open label, so there was no pre-assignment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.\n\nConvalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}], 'populationDescription': 'Data was not collected or analyzed.'}, {'title': 'Age, Continuous', 'unitOfMeasure': 'years', 'populationDescription': 'Data was not collected or analyzed.'}, {'title': 'Age, Customized', 'populationDescription': 'Data was not collected or analyzed.'}, {'title': 'Sex/Gender, Customized', 'populationDescription': 'Data was not collected or analyzed\n\n.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'populationDescription': 'Data was not collected or analyzed.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}], 'populationDescription': 'Data was not collected or analyzed.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}], 'populationDescription': 'Data was not collected or analyzed.'}, {'title': 'Race and Ethnicity Not Collected', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Race/Ethnicity, Customized', 'populationDescription': 'Data was not collected or analyzed.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants', 'populationDescription': 'Data was not collected or analyzed.'}], 'populationDescription': 'Data was not collected or analyzed.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-31', 'size': 483275, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-17T10:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All hospitalized patients meeting study inclusion/exclusion criteria and providing informed consent for participation in the study will receive one unit (approximately 200 mL) of convalescent plasma over one hour to with data collection of routine physical exams/clinical assessments (daily) and routine lab results (every 3 days).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Newly reported data at the time indicated that alternative therapies were more effective than CP for early treatment of high-risk patients with COVID-19.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2020-08-06', 'resultsFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-22', 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19).', 'timeFrame': 'Through study completion, an average of 30 days', 'description': 'Measured by respiratory rate \\>30/min, blood oxygen saturation \\<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \\<300 and received a medical diagnosis of respiratory failure, septic shock or multiple'}], 'secondaryOutcomes': [{'measure': 'Determine the Immunologic Effects of Convalescent Plasma Infusion', 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'SARS-CoV-2 Ag levels through RT-PCR'}, {'measure': 'Absolute Lymphocyte Count (10*3/uL)', 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk'}, {'measure': 'Reatinine Kinase (mg/dL)', 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk'}, {'measure': 'C-reactive Protein (mg/dl)', 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk'}, {'measure': 'D-Dimer (ng/ml FEU)', 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk'}, {'measure': 'Interleukin-6 (pg/ml)', 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk'}, {'measure': 'Ferritin (ng/mL)', 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'Measure normalization of laboratory parameters for risk'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32091533', 'type': 'BACKGROUND', 'citation': 'Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.'}, {'pmid': '32219362', 'type': 'BACKGROUND', 'citation': "Bonow RO, Fonarow GC, O'Gara PT, Yancy CW. Association of Coronavirus Disease 2019 (COVID-19) With Myocardial Injury and Mortality. JAMA Cardiol. 2020 Jul 1;5(7):751-753. doi: 10.1001/jamacardio.2020.1105. No abstract available."}, {'pmid': '32179124', 'type': 'BACKGROUND', 'citation': 'Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.'}, {'pmid': '32171076', 'type': 'BACKGROUND', 'citation': 'Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.'}, {'pmid': '34594836', 'type': 'BACKGROUND', 'citation': 'The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. The Epidemiological Characteristics of an Outbreak of 2019 Novel Coronavirus Diseases (COVID-19) - China, 2020. China CDC Wkly. 2020 Feb 21;2(8):113-122. No abstract available.'}, {'pmid': '32105632', 'type': 'BACKGROUND', 'citation': 'Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.'}, {'pmid': '32221519', 'type': 'BACKGROUND', 'citation': 'Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.'}, {'pmid': '32307245', 'type': 'BACKGROUND', 'citation': 'Jean SS, Lee PI, Hsueh PR. Treatment options for COVID-19: The reality and challenges. J Microbiol Immunol Infect. 2020 Jun;53(3):436-443. doi: 10.1016/j.jmii.2020.03.034. Epub 2020 Apr 4.'}, {'pmid': '32227758', 'type': 'BACKGROUND', 'citation': "Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. 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Passive immune therapy and other immunomodulatory agents for the treatment of severe influenza: Systematic review and meta-analysis. Influenza Other Respir Viruses. 2020 Mar;14(2):226-236. doi: 10.1111/irv.12699. Epub 2019 Nov 16.'}, {'pmid': '15616839', 'type': 'BACKGROUND', 'citation': 'Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.'}, {'pmid': '26735992', 'type': 'BACKGROUND', 'citation': 'van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.'}, {'pmid': '26618098', 'type': 'BACKGROUND', 'citation': 'Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.'}, {'pmid': '32226289', 'type': 'BACKGROUND', 'citation': 'Zhou G, Zhao Q. Perspectives on therapeutic neutralizing antibodies against the Novel Coronavirus SARS-CoV-2. Int J Biol Sci. 2020 Mar 15;16(10):1718-1723. doi: 10.7150/ijbs.45123. eCollection 2020.'}, {'pmid': '32167489', 'type': 'BACKGROUND', 'citation': 'Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.'}, {'pmid': '21248066', 'type': 'BACKGROUND', 'citation': 'Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.'}, {'pmid': '32113510', 'type': 'BACKGROUND', 'citation': 'Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.'}, {'pmid': '32219428', 'type': 'BACKGROUND', 'citation': 'Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.'}, {'type': 'BACKGROUND', 'citation': 'Robeck J. Convalescent Plasma to Treat COVID-19. JAMA - J Am Med Assoc. 2020;Mar 27(Published online).'}, {'pmid': '32253318', 'type': 'BACKGROUND', 'citation': 'Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.'}, {'pmid': '32125452', 'type': 'BACKGROUND', 'citation': 'Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.'}, {'pmid': '32217835', 'type': 'BACKGROUND', 'citation': 'Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. 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Arch Acad Emerg Med. 2020 Mar 24;8(1):e35. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.', 'detailedDescription': "Following the administration of one unit (approximately 200 mL) of convalescent plasma over one hour, the study proposes to determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) by prevention of progression to severe or life threatening COVID-19 during the current hospitalization as determined by evaluating if the patient experienced the following the following: respiratory rate \\>30/min, Blood oxygen saturation \\<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \\<300, or received a medical diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure. This will be captured from the daily physical exam/clinical assessment done as part of routine care and at discharge.\n\nThe study also proposes to determine the immunologic effects of convalescent plasma infusion as measured by serial SARS-CoV-2 Ag levels through RT-PCR measured by CoV PCR collected at enrollment, day 7 and discharge.\n\nFinally, the study intends to measure normalization of laboratory parameters for risk which will be documented every 3 days while the patient is hospitalized until the time that lab value returns to within the institution's normal range."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of SARS-CoV-2 infection via RT-PCR or FDA approved testing.\n* Patients must also have the following indications for enrollment:\n* i. D-Dimer \\> 500 ng/ml FEU OR\n* ii. IL-6\\> 5 pg/mL\n\nWith any of the following:\n\n* iii. Lymphocytes \\< 0.8 103/ul OR\n* iv. LDH \\> 700 U/L OR\n* v. CK \\> 170 U/L OR\n* vi. CRP \\> 1.0 mg/dl OR\n* vii. Ferritin \\> 1000 ng/ml\n\nAND one of the following:\n\n* viii. Age over 60 years\n* ix. Underlying Active Malignancy\n* x. Cardiovascular Disease\n* xi. Active Tobacco Use\n* xii. History of Pulmonary Volume Reduction Surgery\n* xiii. Hypertension\n* Prior Treatment: Patients are still eligible for this trial if active antimicrobial agents are in use. Patients are also eligible if they had been treated on COVID-19 clinical trial in the course of their disease.\n* Age ≥ 18 years.\n* The effects of allogeneic plasma infusion on the developing fetus is unknown. For this reason women who are pregnant are not eligible to participate.\n* Agrees to required laboratory data collected which will include the baseline organ function and regular ongoing assessments done as part of routine care.\n* Ability to understand and the willingness to sign a written informed consent document or ability to have consent provided by Legally Authorized Representative.\n\nExclusion Criteria:\n\n* 4.2.1 Patients who do not meet above inclusion criteria are not eligible.\n* 4.2.2 Patients may not be receiving any other investigational agents.\n* 4.2.3 History of allergic reactions attributed to previous transfusion history.\n* 4.2.4 Respiratory rate \\>30/min\n* 4.2.5 Blood oxygen saturation \\<93%\n* 4.2.6 Partial pressure of arterial oxygen to fraction of inspired oxygen ration \\<300\n* 4.2.7 Diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure'}, 'identificationModule': {'nctId': 'NCT04513158', 'briefTitle': 'Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection', 'organization': {'class': 'OTHER', 'fullName': 'Norton Healthcare'}, 'officialTitle': 'Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection', 'orgStudyIdInfo': {'id': '20-N0124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.', 'interventionNames': ['Biological: Convalescent Plasma']}], 'interventions': [{'name': 'Convalescent Plasma', 'type': 'BIOLOGICAL', 'description': 'Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Norton Women's and Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Audubon Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Brownsboro Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Joseph M Flynn, DO, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norton Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph M. Flynn, D.O., MPH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joseph M. Flynn, D.O., MPH', 'investigatorAffiliation': 'Norton Healthcare'}}}}