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Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (CSSC-004)

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: NCT04373460
Recruitment Status : Completed
First Posted : May 4, 2020
Results First Posted : January 31, 2023
Last Update Posted : June 2, 2023
Sponsor:
Collaborators:
State of Maryland
Bloomberg Foundation
United States Department of Defense
National Institute of Allergy and Infectious Diseases (NIAID)
National Center for Advancing Translational Sciences (NCATS)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition SARS-CoV 2
Interventions Biological: SARS-CoV-2 convalescent plasma
Biological: Plasma from a volunteer donor
Enrollment 1225
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Period Title: Overall Study
Started 610 615
Completed 592 589
Not Completed 18 26
Reason Not Completed
Did not receive tranfusion             18             26
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma Total
Hide Arm/Group Description

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Total of all reporting groups
Overall Number of Baseline Participants 592 589 1181
Hide Baseline Analysis Population Description
Includes participants who were randomized and received transfusion
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 592 participants 589 participants 1181 participants
42
(32 to 54)
44
(33 to 55)
43
(32 to 54)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
18 - 34 years
190
  32.1%
165
  28.0%
355
  30.1%
35 - 49 years
207
  35.0%
208
  35.3%
415
  35.1%
50 - 64 years
155
  26.2%
176
  29.9%
331
  28.0%
>=65 years
40
   6.8%
40
   6.8%
80
   6.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
Female
323
  54.6%
352
  59.8%
675
  57.2%
Male
269
  45.4%
237
  40.2%
506
  42.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
Hispanic or Latino
80
  13.5%
90
  15.3%
170
  14.4%
Not Hispanic or Latino
512
  86.5%
499
  84.7%
1011
  85.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
American Indian or Alaska Native
8
   1.4%
9
   1.5%
17
   1.4%
Asian
22
   3.7%
22
   3.7%
44
   3.7%
Native Hawaiian or Other Pacific Islander
2
   0.3%
2
   0.3%
4
   0.3%
Black or African American
92
  15.5%
71
  12.1%
163
  13.8%
White
459
  77.5%
475
  80.6%
934
  79.1%
More than one race
9
   1.5%
10
   1.7%
19
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
BMI category 1  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
<30
382
  64.5%
355
  60.3%
737
  62.4%
>=30
210
  35.5%
234
  39.7%
444
  37.6%
BMI category 2  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
<35
495
  83.6%
482
  81.8%
977
  82.7%
>=35
97
  16.4%
107
  18.2%
204
  17.3%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
Yes
140
  23.6%
136
  23.1%
276
  23.4%
No
452
  76.4%
453
  76.9%
905
  76.6%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
Yes
49
   8.3%
50
   8.5%
99
   8.4%
No
543
  91.7%
539
  91.5%
1082
  91.6%
Asthma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
Yes
59
  10.0%
73
  12.4%
132
  11.2%
No
533
  90.0%
516
  87.6%
1049
  88.8%
HIV infection  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
Yes
13
   2.2%
12
   2.0%
25
   2.1%
No
579
  97.8%
577
  98.0%
1156
  97.9%
Pregnant  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
Yes
2
   0.3%
1
   0.2%
3
   0.3%
No
590
  99.7%
588
  99.8%
1178
  99.7%
Time from symptom onset to transfusion  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 592 participants 589 participants 1181 participants
6
(4 to 7)
6
(4 to 7)
6
(4 to 7)
Vaccine status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 592 participants 589 participants 1181 participants
Unvaccinated
486
  82.1%
479
  81.3%
965
  81.7%
Partially vaccinated
27
   4.6%
31
   5.3%
58
   4.9%
Fully vaccinated
79
  13.3%
79
  13.4%
158
  13.4%
1.Primary Outcome
Title Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization
Hide Description Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization
Time Frame Up to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who were randomized and received transfusion
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 592 589
Measure Type: Count of Participants
Unit of Measure: Participants
17
   2.9%
37
   6.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SARS-CoV-2 Convalescent Plasma, Standard Control Plasma
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
1.0 to 5.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Cumulative Incidence of Severe Infusion Reactions
Hide Description Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.
Time Frame Up to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who were randomized and received transfusion
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 592 589
Measure Type: Number
Unit of Measure: Rate per person-years
0.05 0.00
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SARS-CoV-2 Convalescent Plasma, Standard Control Plasma
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Rate per person-years
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.11 to 0.02
Estimation Comments [Not Specified]
3.Primary Outcome
Title Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events
Hide Description Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.
Time Frame Up to day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 592 589
Measure Type: Number
Unit of Measure: Rate per person-years
0.25 0.43
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SARS-CoV-2 Convalescent Plasma, Standard Control Plasma
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Rate per person-years
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence rate difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
0.03 to 0.32
Estimation Comments [Not Specified]
4.Primary Outcome
Title Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)
Hide Description Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.
Time Frame Up to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who were randomized and received transfusion
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 592 589
Measure Type: Number
Unit of Measure: Rate per person-years
0.00 0.01
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SARS-CoV-2 Convalescent Plasma, Standard Control Plasma
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Rate per person-years
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.01 to 0.02
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Serum SARS-CoV-2 Antibody Titers by Visit
Hide Description Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms.
Time Frame Days 0, 14, 28 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis limited to those that were transfused and had the titer data performed
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 577 564
Geometric Mean (95% Confidence Interval)
Unit of Measure: Spike Receptor Binding Domain Titer
Pre-transfusion Number Analyzed 577 participants 564 participants
345
(276 to 431)
316
(254 to 393)
Day 14 Number Analyzed 553 participants 546 participants
8595
(7211 to 10245)
9868
(8217 to 11851)
Day 28 Number Analyzed 541 participants 534 participants
10980
(9196 to 13111)
12241
(10215 to 14668)
Day 90 Number Analyzed 529 participants 518 participants
13958
(11577 to 16829)
13281
(10979 to 16065)
6.Other Pre-specified Outcome
Title Number of Participants With ICU Admission
Hide Description Disease severity measured by admission to the ICU
Time Frame Up to day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who were randomized and received transfusion
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 592 589
Measure Type: Count of Participants
Unit of Measure: Participants
Admission to ICU
3
   0.5%
7
   1.2%
No admission to ICU
589
  99.5%
582
  98.8%
7.Other Pre-specified Outcome
Title Number of Participants With Invasive Mechanical Ventilation
Hide Description Disease severity measured by invasive mechanical ventilation
Time Frame Up to day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 592 589
Measure Type: Count of Participants
Unit of Measure: Participants
On invasive mechanical ventilation
0
   0.0%
3
   0.5%
No invasive mechanical ventilation
592
 100.0%
586
  99.5%
8.Other Pre-specified Outcome
Title Number of Participants Who Died
Hide Description Disease severity measured by death
Time Frame Up to day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who were randomized and received transfusion
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 592 589
Measure Type: Count of Participants
Unit of Measure: Participants
Deaths
0
   0.0%
3
   0.5%
No deaths
592
 100.0%
586
  99.5%
9.Other Pre-specified Outcome
Title Number of Participants With Resolved COVID-19 Symptoms at Day 14
Hide Description Number of participants with resolved COVID-19 symptoms at day 14
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were transfused and had symptom data for day 14
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 560 554
Measure Type: Count of Participants
Unit of Measure: Participants
146
  26.1%
134
  24.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SARS-CoV-2 Convalescent Plasma, Standard Control Plasma
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Other Pre-specified Outcome
Title Number of Participants With Resolved COVID-19 Symptoms at Day 28
Hide Description Number of participants with resolved COVID-19 symptoms at day 28
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were transfused and had symptom data for day 28
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 553 544
Measure Type: Count of Participants
Unit of Measure: Participants
250
  45.2%
245
  45.0%
11.Other Pre-specified Outcome
Title Number of Participants With Resolved COVID-19 Symptoms at Day 90
Hide Description Number of participants with resolved COVID-19 symptoms at day 90
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were transfused and had symptom data for day 90
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 533 528
Measure Type: Count of Participants
Unit of Measure: Participants
359
  67.4%
347
  65.7%
12.Other Pre-specified Outcome
Title Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate
Hide Description Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups <65 and >=65
Time Frame Day 0 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who were randomized and received transfusion
Arm/Group Title SARS-CoV-2 Convalescent Plasma Total Age < 65 Standard Control Plasma Total Age <65
Hide Arm/Group Description:

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Overall Number of Participants Analyzed 592 589
Measure Type: Count of Participants
Unit of Measure: Participants
Age group < 65 Number Analyzed 552 participants 549 participants
Primary event of hospitalization
12
   2.2%
29
   5.3%
No primary event of hospitalization
540
  97.8%
520
  94.7%
Age group >= 65 Number Analyzed 40 participants 40 participants
Primary event of hospitalization
5
  12.5%
8
  20.0%
No primary event of hospitalization
35
  87.5%
32
  80.0%
13.Other Pre-specified Outcome
Title Impact of Donor Antibody Titers on Hospitalization Rate of Convalescent Plasma Recipients
Hide Description Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations.
Time Frame Day 0 to Day28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis limited to those that had the donor titer measured
Arm/Group Title SARS-CoV-2 Convalescent Plasma (High Titer) SARS-CoV-2 Convalescent Plasma (Low Titer)
Hide Arm/Group Description:
High titer refers >= median donor dilutional neutralizing virus titer
Low titer refers to < median donor dilutional neutralizing virus titer
Overall Number of Participants Analyzed 302 264
Measure Type: Count of Participants
Unit of Measure: Participants
Hospitalized
6
   2.0%
10
   3.8%
Not hospitalized
296
  98.0%
254
  96.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SARS-CoV-2 Convalescent Plasma (High Titer), SARS-CoV-2 Convalescent Plasma (Low Titer)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.525
Confidence Interval (2-Sided) 95%
0.192 to 1.425
Estimation Comments [Not Specified]
Time Frame 90 days
Adverse Event Reporting Description We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
 
Arm/Group Title SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Hide Arm/Group Description

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

All-Cause Mortality
SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Affected / at Risk (%) Affected / at Risk (%)
Total   0/592 (0.00%)      3/589 (0.51%)    
Hide Serious Adverse Events
SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/592 (5.74%)      55/589 (9.34%)    
Blood and lymphatic system disorders     
Leukocytosis  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Cardiac disorders     
Chest pain - cardiac  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Gastrointestinal disorders     
Gastric ulcer  1  1/592 (0.17%)  1 0/589 (0.00%)  0
Pancreatitis  2  1/592 (0.17%)  1 1/589 (0.17%)  1
Vomiting  1  1/592 (0.17%)  1 1/589 (0.17%)  1
General disorders     
Non-cardiac chest pain  1  1/592 (0.17%)  1 1/589 (0.17%)  1
Infections and infestations     
Bronchial infection  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Kidney Infection  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Pneumonia  1  14/592 (2.36%)  14 31/589 (5.26%)  31
Injury, poisoning and procedural complications     
Infusion related reaction  1  1/592 (0.17%)  1 1/589 (0.17%)  1
Investigations     
Neutrophil count decreased  1  0/592 (0.00%)  0 1/589 (0.17%)  1
White blood cell decreased  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Metabolism and nutrition disorders     
Hyperglycemia  1  1/592 (0.17%)  1 0/589 (0.00%)  0
Nervous system disorders     
Headache  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Syncope  1  1/592 (0.17%)  1 0/589 (0.00%)  0
Vasovagal reaction  1  4/592 (0.68%)  4 2/589 (0.34%)  2
Psychiatric disorders     
Depression  1  2/592 (0.34%)  2 0/589 (0.00%)  0
Hallucinations  1  1/592 (0.17%)  1 0/589 (0.00%)  0
Renal and urinary disorders     
Renal calculi  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Urinary tract obstruction  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  1/592 (0.17%)  1 0/589 (0.00%)  0
Dyspnea  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Hypoxia  1  0/592 (0.00%)  0 3/589 (0.51%)  3
Pneumonitis  1  0/592 (0.00%)  0 2/589 (0.34%)  2
Sinus pain  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Vascular disorders     
Flushing  1  1/592 (0.17%)  1 0/589 (0.00%)  0
Hypertension  1  2/592 (0.34%)  2 1/589 (0.17%)  1
Hypotension  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Thromboembolic event  2  2/592 (0.34%)  2 0/589 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
2
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SARS-CoV-2 Convalescent Plasma Standard Control Plasma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   106/592 (17.91%)      109/589 (18.51%)    
Blood and lymphatic system disorders     
Anemia  1  1/592 (0.17%)  1 0/589 (0.00%)  0
Lymph node pain  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  2  0/592 (0.00%)  0 2/589 (0.34%)  2
Atrial flutter  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Chest pain - cardiac  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Palpitations  2  2/592 (0.34%)  2 1/589 (0.17%)  1
Sinus tachycardia  2  3/592 (0.51%)  3 1/589 (0.17%)  1
Ear and labyrinth disorders     
Ear pain  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Tinnitus  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Vertigo  2  1/592 (0.17%)  1 1/589 (0.17%)  1
Eye disorders     
Blurred vision  2  1/592 (0.17%)  1 1/589 (0.17%)  1
Burning and itching eyes  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Eye pain  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Glaucoma  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Left Lower Eyelid Edema  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Retinal tear  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  2  1/592 (0.17%)  1 1/589 (0.17%)  1
Anal Fistula  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Constipation  2  1/592 (0.17%)  1 2/589 (0.34%)  2
Diarrhea  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Dry mouth  2  1/592 (0.17%)  1 1/589 (0.17%)  1
Gastritis  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Nausea  2  1/592 (0.17%)  1 2/589 (0.34%)  2
Esophageal ulcer  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Toothache  2  2/592 (0.34%)  2 0/589 (0.00%)  0
Vomiting  2  2/592 (0.34%)  2 0/589 (0.00%)  0
General disorders     
Edema limbs  2  0/592 (0.00%)  0 2/589 (0.34%)  2
Fever  2  3/592 (0.51%)  3 2/589 (0.34%)  2
Heavy chest pain feeling  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Infusion site extravasation  2  1/592 (0.17%)  1 2/589 (0.34%)  2
Injection site reaction  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Non-cardiac chest pain  2  3/592 (0.51%)  3 2/589 (0.34%)  2
Pain  2  2/592 (0.34%)  2 0/589 (0.00%)  0
Worsening Anxiety  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Hepatobiliary disorders     
Cholelithiasis  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Immune system disorders     
Allergic reaction  2  0/592 (0.00%)  0 2/589 (0.34%)  2
Post-vaccine reaction  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Infections and infestations     
Bladder infection  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Bronchial infection  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Conjunctivitis  1  0/592 (0.00%)  0 2/589 (0.34%)  2
Folliculitis  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Herpes simplex reactivation  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Pharyngitis  2  3/592 (0.51%)  3 0/589 (0.00%)  0
Pneumonia  2  1/592 (0.17%)  1 2/589 (0.34%)  2
Shingles  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Sinusitis  2  1/592 (0.17%)  1 2/589 (0.34%)  2
Upper respiratory infection  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Urinary tract infection  2  5/592 (0.84%)  5 4/589 (0.68%)  4
Vaginal infection  2  2/592 (0.34%)  2 0/589 (0.00%)  0
Injury, poisoning and procedural complications     
Burn  2  1/592 (0.17%)  1 1/589 (0.17%)  1
Facial contusions secondary to assault  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Fall  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Infusion related reaction  2  13/592 (2.20%)  13 15/589 (2.55%)  15
Laceration of Forehead  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Investigations     
Weight loss  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Metabolism and nutrition disorders     
Alcohol intolerance  2  1/592 (0.17%)  1 1/589 (0.17%)  1
Hyperlipidemia  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Arthralgia  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Back pain  2  1/592 (0.17%)  1 1/589 (0.17%)  1
Chest wall pain  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Muscle spasms in lower extremities  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Myalgia  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Pain in extremity  2  1/592 (0.17%)  2 2/589 (0.34%)  2
Right knee sprain  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Nervous system disorders     
Dizziness  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Headache  2  3/592 (0.51%)  3 1/589 (0.17%)  1
Hypersomnia  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Paresthesia  2  2/592 (0.34%)  2 0/589 (0.00%)  0
Neuralgia  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Transient ischemic attacks  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Tremor  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Twitch in lip  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Psychiatric disorders     
Anxiety  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Depression  2  1/592 (0.17%)  1 2/589 (0.34%)  2
Renal and urinary disorders     
Renal calculi  2  2/592 (0.34%)  2 0/589 (0.00%)  0
Urinary retention  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Urine discoloration  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Dyspnea  1  0/592 (0.00%)  0 1/589 (0.17%)  1
Epistaxis  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Hypoxia  2  0/592 (0.00%)  0 2/589 (0.34%)  2
Laryngeal edema  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  2  1/592 (0.17%)  1 2/589 (0.34%)  2
Dry skin  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Erythema multiforme  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Hyperkeratosis  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Pruritis  2  1/592 (0.17%)  1 2/589 (0.34%)  2
Rash acneiform  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Rash maculo-papular  2  2/592 (0.34%)  2 5/589 (0.85%)  5
Skin ulceration  2  1/592 (0.17%)  1 0/589 (0.00%)  0
Urticaria  2  9/592 (1.52%)  9 10/589 (1.70%)  10
Vascular disorders     
Hypertension  2  4/592 (0.68%)  4 3/589 (0.51%)  3
Hypotension  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Lymphedema  2  0/592 (0.00%)  0 1/589 (0.17%)  1
Thromboembolic event  2  1/592 (0.17%)  1 0/589 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
2
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David J. Sullivan
Organization: Johns Hopkins University Bloomberg School of Public Health
Phone: 410-502-2522
EMail: dsulliv7@jh.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04373460    
Other Study ID Numbers: IRB00247590
R01AI152078 ( U.S. NIH Grant/Contract )
W911QY2090012 ( Other Grant/Funding Number: Department of Defense )
U24TR001609 ( U.S. NIH Grant/Contract )
UL1TR003098 ( U.S. NIH Grant/Contract )
First Submitted: April 30, 2020
First Posted: May 4, 2020
Results First Submitted: December 21, 2022
Results First Posted: January 31, 2023
Last Update Posted: June 2, 2023