Convalescent Plasma vs. Standard Plasma for COVID-19

• ClinicalTrials.gov Identifier: NCT04344535
• Recruitment Status: Terminated
• First Posted: April 14, 2020
• Results First Posted: December 6, 2021
• Last Update Posted: December 6, 2021
• Sponsor: Stony Brook University
• Information provided by (Responsible Party): Elliott Bennett-Guerrero, Stony Brook University

Tracking Information

• First Submitted Date: April 10, 2020
• First Posted Date: April 14, 2020
• Results First Submitted Date: September 20, 2021
• Results First Posted Date: December 6, 2021
• Last Update Posted Date: December 6, 2021
• Actual Study Start Date: April 8, 2020
• Actual Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 20, 2021)

28 Day Ventilator Free Days [ Time Frame: 28 days post randomization ]

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.

Original Primary Outcome Measures (submitted: April 13, 2020)

28 day ventilator free days [ Time Frame: 28 days post randomization ]

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.

Current Secondary Outcome Measures (submitted: September 20, 2021)

90 Day All-cause Mortality [ Time Frame: 90 days ]

All cause mortality from randomization until 90 days post randomization

Original Secondary Outcome Measures (submitted: April 13, 2020)

90 day all-cause mortality [ Time Frame: 90 days ]

All cause mortality from randomization until 90 days post randomization

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Convalescent Plasma vs. Standard Plasma for COVID-19
• Official Title: Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment

• Condition: COVID

Intervention

• Biological: 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.
• Biological: Standard Donor Plasma
  450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies

Study Arms

• Active Comparator: Convalescent Donor Plasma
  Intervention: Biological: Convalescent Plasma
• Placebo Comparator: Standard Donor Plasma
  Intervention: Biological: Standard Donor Plasma

Publications *

• 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. 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 29, 2021): 82
• Original Estimated Enrollment (submitted: April 13, 2020): 500
• Actual Study Completion Date: February 1, 2021
• Actual Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

There are 2 groups of research subjects: plasma donor and recipients

Volunteer plasma donors can donate Convalescent Plasma if they:

• have adequate antibody levels against COVID-19 per FDA Guidelines
• have had no symptoms of COVID-19 for at least 14 days
• meet routine plasma donation criteria

Inclusion Criteria for Plasma Recipients:

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

Exclusion Criteria for Plasma Recipients:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04344535
• Other Study ID Numbers: SBU-COVID19-ConvalescentPlasma
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Elliott Bennett-Guerrero, Stony Brook University
• Original Responsible Party: Same as current
• Current Study Sponsor: Stony Brook University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Elliott Bennett-Guerrero, MD; Stony Brook Hospital

• PRS Account: Stony Brook University
• Verification Date: December 2021