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

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ClinicalTrials.gov Identifier: NCT04373460

Recruitment Status : Completed

First Posted : May 4, 2020

Results First Posted : January 31, 2023

Last Update Posted : January 31, 2023

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	SARS-CoV-2 Convalescent Plasma	Standard Control Plasma
Arm/Group Description	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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

Baseline Characteristics

Arm/Group Title		SARS-CoV-2 Convalescent Plasma	Standard Control Plasma	Total
Arm/Group Description		SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization
Description	Cumulative Number measured as the proportion of subjects who were hosp...
Description	Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization
Time Frame	Up to day 28

Outcome Measure Data

Analysis Population Description

Includes patients who were randomized and received transfusion


Arm/Group Title	SARS-CoV-2 Convalescent Plasma	Standard Control Plasma
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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%

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
Description	Cumulative incidence measured as rate per person-years experiencing tr...
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

Outcome Measure Data

Analysis Population Description

Includes patients who were randomized and received transfusion


Arm/Group Title	SARS-CoV-2 Convalescent Plasma	Standard Control Plasma
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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

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
Description	Cumulative incidence measured as rate per person-years experiencing a ...
Description	Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.
Time Frame	Up to day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	SARS-CoV-2 Convalescent Plasma	Standard Control Plasma
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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

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)
Description	Cumulative incidence measured as rate per person-years of treatment-re...
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

Outcome Measure Data

Analysis Population Description

Includes patients who were randomized and received transfusion


Arm/Group Title	SARS-CoV-2 Convalescent Plasma	Standard Control Plasma
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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

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
Description	Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14...
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

Outcome Measure Data

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
Arm/Group Description:		SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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
Pre-transfusion		345 (276 to 431)	316 (254 to 393)
Day 14	Number Analyzed	553 participants	546 participants
Day 14		8595 (7211 to 10245)	9868 (8217 to 11851)
Day 28	Number Analyzed	541 participants	534 participants
Day 28		10980 (9196 to 13111)	12241 (10215 to 14668)
Day 90	Number Analyzed	529 participants	518 participants
Day 90		13958 (11577 to 16829)	13281 (10979 to 16065)

6.Other Pre-specified Outcome


Title	Number of Participants With ICU Admission
Description	Disease severity measured by admission to the ICU
Description	Disease severity measured by admission to the ICU
Time Frame	Up to day 90

Outcome Measure Data

Analysis Population Description

Includes patients who were randomized and received transfusion


Arm/Group Title	SARS-CoV-2 Convalescent Plasma	Standard Control Plasma
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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
Description	Disease severity measured by invasive mechanical ventilation
Description	Disease severity measured by invasive mechanical ventilation
Time Frame	Up to day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	SARS-CoV-2 Convalescent Plasma	Standard Control Plasma
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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
Description	Disease severity measured by death
Description	Disease severity measured by death
Time Frame	Up to day 90

Outcome Measure Data

Analysis Population Description

Includes patients who were randomized and received transfusion


Arm/Group Title	SARS-CoV-2 Convalescent Plasma	Standard Control Plasma
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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
Description	Number of participants with resolved COVID-19 symptoms at day 14
Description	Number of participants with resolved COVID-19 symptoms at day 14
Time Frame	Day 14

Outcome Measure Data

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
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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%

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
Description	Number of participants with resolved COVID-19 symptoms at day 28
Description	Number of participants with resolved COVID-19 symptoms at day 28
Time Frame	Day 28

Outcome Measure Data

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
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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
Description	Number of participants with resolved COVID-19 symptoms at day 90
Description	Number of participants with resolved COVID-19 symptoms at day 90
Time Frame	Day 90

Outcome Measure Data

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
Arm/Group Description:	SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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
Description	Assess change in hospitalization rate as measured by number of hospita...
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

Outcome Measure Data

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
Arm/Group Description:		SARS-CoV-2 convalescent plasma (1 c...	Plasma collected from a volunteer d...
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
Description	Impact of donor antibody titers (high/low) will be assessed by hospita...
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

Outcome Measure Data

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)
Arm/Group Description:	High titer refers >= median donor d...	Low titer refers to < median donor ...
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%

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]

Adverse Events

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
Arm/Group Description	SARS-CoV-2 convalescent plasma (1 c...		Plasma collected from a volunteer d...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

Publications of Results:

Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma. medRxiv. 2021 Dec 21:2021.12.10.21267485. doi: 10.1101/2021.12.10.21267485. Preprint.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Early Outpatient Treatment for Covid-19 with Convalescent Plasma. N Engl J Med. 2022 May 5;386(18):1700-1711. doi: 10.1056/NEJMoa2119657. Epub 2022 Mar 30.

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:	January 31, 2023

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