Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
82 participants
INTERVENTIONAL
2020-04-08
2021-02-01
Brief Summary
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Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Convalescent Donor Plasma
Convalescent Plasma
450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.
Standard Donor Plasma
Standard Donor Plasma
450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Interventions
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Convalescent Plasma
450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.
Standard Donor Plasma
450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Eligibility Criteria
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Inclusion Criteria
* Hospitalized with PCR+ COVID-19 infection
* If female must not be pregnant and/or breastfeeding.
Exclusion Criteria
* In the treating physician's opinion, the patient cannot tolerate a 450-550 mL infusion of plasma over up to 8 hours (4 hours max per unit), even if prophylaxed with intravenous diuretic
* Contraindication to transfusion or history of prior reactions to blood transfusions
18 Years
ALL
No
Sponsors
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Stony Brook University
OTHER
Responsible Party
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Elliott Bennett-Guerrero
Professor of Anesthesiology
Principal Investigators
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Elliott Bennett-Guerrero, MD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook Hospital
Locations
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Stony Brook University Hospital
Stony Brook, New York, United States
Countries
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References
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Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Bennett-Guerrero E, Romeiser JL, Talbot LR, Ahmed T, Mamone LJ, Singh SM, Hearing JC, Salman H, Holiprosad DD, Freedenberg AT, Carter JA, Browne NJ, Cosgrove ME, Shevik ME, Generale LM, Andrew MA, Nachman S, Fries BC; Stony Brook Medicine COVID Plasma Trial Group; Stony Brook Medicine COVID Plasma Trial Group are as follows: Investigators; Principal Investigator, Critical Care; Pathology/Blood Bank; Infectious Disease; Safety Monitor; Biostatistics; Hematology; (Blood Bank; and; Pathology, Laboratory Services). Team 1 (Online Survey/In Person Scheduling); Team Leader; and; Team 2 (In Person Screening Visits); Team Leader; and; Team 3 (Patient/Recipient Screening, Plasma Administration, Data Capture); Team Leader; and; and; and; and; Team M (Antibody Testing/Randomization):; Team Leader; and; Plaque Reduction Neutralization Assay: Janet Hearing. Regulatory (Investigational New Drug [IND] and Institutional Review Board [IRB] support); (IND support); (IRB support), and; Data and Safety Monitoring Board (DSMB); and; (Chair) and; (unblinded DSMB statistician); Stony Brook Medicine COVID Plasma Trial Group and Stony Brook Medicine COVID Plasma Trial Group are as follows: Investigators and Principal Investigator, Critical Care and Pathology/Blood Bank and Infectious Disease and Safety Monitor and Biostatistics and Hematology and (Blood Bank and and and Pathology, Laboratory Services). Team 1 (Online Survey/In Person Scheduling) and Team Leader and and and Team 2 (In Person Screening Visits) and Team Leader and and and Team 3 (Patient/Recipient Screening, Plasma Administration, Data Capture) and Team Leader and and and and and and and and and Team M (Antibody Testing/Randomization): and Team Leader and and and Plaque Reduction Neutralization Assay: Janet Hearing. Regulatory (Investigational New Drug [IND] and Institutional Review Board [IRB] support) and (IND support) and (IRB support), and and Data and Safety Monitoring Board (DSMB) and and and (Chair) and and (unblinded DSMB statistician). Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York: A Double-Blind Randomized Trial. Crit Care Med. 2021 Jul 1;49(7):1015-1025. doi: 10.1097/CCM.0000000000005066.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SBU-COVID19-ConvalescentPlasma
Identifier Type: -
Identifier Source: org_study_id