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Convalescent Plasma vs. Standard Plasma for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344535
Recruitment Status : Terminated (Insufficient eligible and consenting patients)
First Posted : April 14, 2020
Results First Posted : December 6, 2021
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Elliott Bennett-Guerrero, Stony Brook University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition COVID
Interventions Biological: Convalescent Plasma
Biological: Standard Donor Plasma
Enrollment 82
Recruitment Details  
Pre-assignment Details 8 screen failures prior to randomization, thus 74 patients were randomized.
Arm/Group Title Convalescent Donor Plasma Standard Donor Plasma
Hide Arm/Group Description 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
Period Title: Overall Study
Started 59 15
Completed 59 15
Not Completed 0 0
Arm/Group Title Convalescent Donor Plasma Standard Donor Plasma Total
Hide Arm/Group Description 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 Total of all reporting groups
Overall Number of Baseline Participants 59 15 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 15 participants 74 participants
67  (15.8) 64  (17.4) 66  (16.1)
[1]
Measure Description: years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 15 participants 74 participants
Female
23
  39.0%
7
  46.7%
30
  40.5%
Male
36
  61.0%
8
  53.3%
44
  59.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 59 participants 15 participants 74 participants
42
  71.2%
8
  53.3%
50
  67.6%
Black Number Analyzed 59 participants 15 participants 74 participants
5
   8.5%
1
   6.7%
6
   8.1%
Other Number Analyzed 59 participants 15 participants 74 participants
12
  20.3%
6
  40.0%
18
  24.3%
1.Primary Outcome
Title 28 Day Ventilator Free Days
Hide Description 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.
Time Frame 28 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized
Arm/Group Title Convalescent Donor Plasma Standard Donor Plasma
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 59 15
Median (Inter-Quartile Range)
Unit of Measure: days
28
(2 to 28)
28
(0 to 28)
2.Secondary Outcome
Title 90 Day All-cause Mortality
Hide Description All cause mortality from randomization until 90 days post randomization
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized
Arm/Group Title Convalescent Donor Plasma Standard Donor Plasma
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 59 15
Measure Type: Count of Participants
Unit of Measure: Participants
16
  27.1%
5
  33.3%
Time Frame Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.
Adverse Event Reporting Description Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.
 
Arm/Group Title Convalescent Donor Plasma Standard Donor Plasma
Hide Arm/Group Description 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
All-Cause Mortality
Convalescent Donor Plasma Standard Donor Plasma
Affected / at Risk (%) Affected / at Risk (%)
Total   16/59 (27.12%)   5/15 (33.33%) 
Hide Serious Adverse Events
Convalescent Donor Plasma Standard Donor Plasma
Affected / at Risk (%) Affected / at Risk (%)
Total   8/59 (13.56%)   1/15 (6.67%) 
Blood and lymphatic system disorders     
Hematologic Failure † [1]  1/59 (1.69%)  1/15 (6.67%) 
Infusion Reaction † [2]  1/59 (1.69%)  0/15 (0.00%) 
Hepatobiliary disorders     
Liver Failure † [3]  3/59 (5.08%)  0/15 (0.00%) 
Renal and urinary disorders     
Renal Failure † [4]  5/59 (8.47%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Failure † [5]  2/59 (3.39%)  0/15 (0.00%) 
†
Indicates events were collected by systematic assessment
[1]
Grade 4 or greater Hematologic Failure
[2]
Infusion reaction resulting in termination of study plasma infusion
[3]
Grade 4 or greater Liver Failure
[4]
Grade 4 or greater Renal Failure
[5]
Grade 4 or greater Pulmonary Failure
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Convalescent Donor Plasma Standard Donor Plasma
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/15 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elliott Bennett-Guerrero
Organization: Stony Brook University
Phone: 6314446026
EMail: elliott.bennett-guerrero@stonybrookmedicine.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Elliott Bennett-Guerrero, Stony Brook University
ClinicalTrials.gov Identifier: NCT04344535    
Other Study ID Numbers: SBU-COVID19-ConvalescentPlasma
First Submitted: April 10, 2020
First Posted: April 14, 2020
Results First Submitted: September 20, 2021
Results First Posted: December 6, 2021
Last Update Posted: December 6, 2021