Convalescent Plasma vs. Standard Plasma for COVID-19

NCT04344535 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: SBU-COVID19-ConvalescentPlasma
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients. 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.

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

• 28 Day Ventilator Free Days

  Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days.

  28 days post randomization

Secondary Outcomes (1)

• 90 Day All-cause Mortality

  90 days

Study Arms (2)

Convalescent Donor Plasma

ACTIVE COMPARATOR

Biological: Convalescent Plasma

Standard Donor Plasma

PLACEBO COMPARATOR

Biological: Standard Donor Plasma

Interventions

Convalescent Plasma BIOLOGICAL

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.

Convalescent Donor Plasma

Standard Donor Plasma BIOLOGICAL

450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies

Standard Donor Plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or older
• Hospitalized with PCR+ COVID-19 infection
• If female must not be pregnant and/or breastfeeding.

You may not qualify if:

• Unable to randomize patient within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer to Stony Brook Hospital).
• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Related Publications (4)

• 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.

  PMID: 37162745 DERIVED

• 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.

  PMID: 36734509 DERIVED

• 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.

  PMID: 34013969 DERIVED

• 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.

  PMID: 33870923 DERIVED

Results Point of Contact

• Title: Elliott Bennett-Guerrero
• Organization: Stony Brook University

elliott.bennett-guerrero@stonybrookmedicine.edu

6314446026

Study Officials

• Elliott Bennett-Guerrero, MD

  Stony Brook Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Staff in Transfusion Services (Blood Bank) at Stony Brook will be unblinded so they can collect, store, and dispense either convalescent plasma or standard plasma. They will affix an approved label with all required information, e.g. bar code, blood type, expiration date, and will indicate that the bag contains convalescent plasma/standard plasma.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: April 8, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)