Trial Outcomes & Findings for Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (NCT NCT04373460)

NCT ID: NCT04373460

Last Updated: 2023-06-02

Results Overview

Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1225 participants

Primary outcome timeframe

Up to day 28

Results posted on

2023-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	Standard Control 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 Study STARTED	610	615
Overall Study COMPLETED	592	589
Overall Study NOT COMPLETED	18	26

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	Standard Control 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 Study Did not receive tranfusion	18	26

Baseline Characteristics

Convalescent Plasma to Limit SARS-CoV-2 Associated Complications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SARS-CoV-2 Convalescent Plasma n=592 Participants 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.	Standard Control Plasma n=589 Participants 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 n=1181 Participants Total of all reporting groups
Age, Continuous	42 years n=93 Participants	44 years n=4 Participants	43 years n=27 Participants
Age, Customized 18 - 34 years	190 Participants n=93 Participants	165 Participants n=4 Participants	355 Participants n=27 Participants
Age, Customized 35 - 49 years	207 Participants n=93 Participants	208 Participants n=4 Participants	415 Participants n=27 Participants
Age, Customized 50 - 64 years	155 Participants n=93 Participants	176 Participants n=4 Participants	331 Participants n=27 Participants
Age, Customized >=65 years	40 Participants n=93 Participants	40 Participants n=4 Participants	80 Participants n=27 Participants
Sex: Female, Male Female	323 Participants n=93 Participants	352 Participants n=4 Participants	675 Participants n=27 Participants
Sex: Female, Male Male	269 Participants n=93 Participants	237 Participants n=4 Participants	506 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	80 Participants n=93 Participants	90 Participants n=4 Participants	170 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	512 Participants n=93 Participants	499 Participants n=4 Participants	1011 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Race (NIH/OMB) Asian	22 Participants n=93 Participants	22 Participants n=4 Participants	44 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Black or African American	92 Participants n=93 Participants	71 Participants n=4 Participants	163 Participants n=27 Participants
Race (NIH/OMB) White	459 Participants n=93 Participants	475 Participants n=4 Participants	934 Participants n=27 Participants
Race (NIH/OMB) More than one race	9 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
BMI category 1 <30	382 Participants n=93 Participants	355 Participants n=4 Participants	737 Participants n=27 Participants
BMI category 1 >=30	210 Participants n=93 Participants	234 Participants n=4 Participants	444 Participants n=27 Participants
BMI category 2 <35	495 Participants n=93 Participants	482 Participants n=4 Participants	977 Participants n=27 Participants
BMI category 2 >=35	97 Participants n=93 Participants	107 Participants n=4 Participants	204 Participants n=27 Participants
Hypertension Yes	140 Participants n=93 Participants	136 Participants n=4 Participants	276 Participants n=27 Participants
Hypertension No	452 Participants n=93 Participants	453 Participants n=4 Participants	905 Participants n=27 Participants
Diabetes Yes	49 Participants n=93 Participants	50 Participants n=4 Participants	99 Participants n=27 Participants
Diabetes No	543 Participants n=93 Participants	539 Participants n=4 Participants	1082 Participants n=27 Participants
Asthma Yes	59 Participants n=93 Participants	73 Participants n=4 Participants	132 Participants n=27 Participants
Asthma No	533 Participants n=93 Participants	516 Participants n=4 Participants	1049 Participants n=27 Participants
HIV infection Yes	13 Participants n=93 Participants	12 Participants n=4 Participants	25 Participants n=27 Participants
HIV infection No	579 Participants n=93 Participants	577 Participants n=4 Participants	1156 Participants n=27 Participants
Pregnant Yes	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Pregnant No	590 Participants n=93 Participants	588 Participants n=4 Participants	1178 Participants n=27 Participants
Time from symptom onset to transfusion	6 days n=93 Participants	6 days n=4 Participants	6 days n=27 Participants
Vaccine status Unvaccinated	486 Participants n=93 Participants	479 Participants n=4 Participants	965 Participants n=27 Participants
Vaccine status Partially vaccinated	27 Participants n=93 Participants	31 Participants n=4 Participants	58 Participants n=27 Participants
Vaccine status Fully vaccinated	79 Participants n=93 Participants	79 Participants n=4 Participants	158 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to day 28

Population: Includes patients who were randomized and received transfusion

Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=592 Participants 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.	Standard Control Plasma n=589 Participants 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.
Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization	17 Participants	37 Participants

PRIMARY outcome

Timeframe: Up to day 28

Population: Includes patients who were randomized and received transfusion

Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=592 Participants 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.	Standard Control Plasma n=589 Participants 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.
Cumulative Incidence of Severe Infusion Reactions	0.05 Rate per person-years	0.00 Rate per person-years

PRIMARY outcome

Timeframe: Up to day 90

Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=592 Participants 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.	Standard Control Plasma n=589 Participants 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.
Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events	0.25 Rate per person-years	0.43 Rate per person-years

PRIMARY outcome

Timeframe: Up to day 28

Population: Includes patients who were randomized and received transfusion

Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=592 Participants 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.	Standard Control Plasma n=589 Participants 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.
Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)	0.00 Rate per person-years	0.01 Rate per person-years

SECONDARY outcome

Timeframe: Days 0, 14, 28 and 90

Population: Analysis limited to those that were transfused and had the titer data performed

Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=577 Participants 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.	Standard Control Plasma n=564 Participants 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.
Serum SARS-CoV-2 Antibody Titers by Visit Day 14	8595 Spike Receptor Binding Domain Titer Interval 7211.0 to 10245.0	9868 Spike Receptor Binding Domain Titer Interval 8217.0 to 11851.0
Serum SARS-CoV-2 Antibody Titers by Visit Pre-transfusion	345 Spike Receptor Binding Domain Titer Interval 276.0 to 431.0	316 Spike Receptor Binding Domain Titer Interval 254.0 to 393.0
Serum SARS-CoV-2 Antibody Titers by Visit Day 28	10980 Spike Receptor Binding Domain Titer Interval 9196.0 to 13111.0	12241 Spike Receptor Binding Domain Titer Interval 10215.0 to 14668.0
Serum SARS-CoV-2 Antibody Titers by Visit Day 90	13958 Spike Receptor Binding Domain Titer Interval 11577.0 to 16829.0	13281 Spike Receptor Binding Domain Titer Interval 10979.0 to 16065.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to day 90

Population: Includes patients who were randomized and received transfusion

Disease severity measured by admission to the ICU

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=592 Participants 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.	Standard Control Plasma n=589 Participants 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.
Number of Participants With ICU Admission No admission to ICU	589 Participants	582 Participants
Number of Participants With ICU Admission Admission to ICU	3 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to day 90

Disease severity measured by invasive mechanical ventilation

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=592 Participants 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.	Standard Control Plasma n=589 Participants 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.
Number of Participants With Invasive Mechanical Ventilation On invasive mechanical ventilation	0 Participants	3 Participants
Number of Participants With Invasive Mechanical Ventilation No invasive mechanical ventilation	592 Participants	586 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to day 90

Population: Includes patients who were randomized and received transfusion

Disease severity measured by death

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=592 Participants 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.	Standard Control Plasma n=589 Participants 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.
Number of Participants Who Died Deaths	0 Participants	3 Participants
Number of Participants Who Died No deaths	592 Participants	586 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Population: All participants who were transfused and had symptom data for day 14

Number of participants with resolved COVID-19 symptoms at day 14

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=560 Participants 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.	Standard Control Plasma n=554 Participants 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.
Number of Participants With Resolved COVID-19 Symptoms at Day 14	146 Participants	134 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28

Population: All participants who were transfused and had symptom data for day 28

Number of participants with resolved COVID-19 symptoms at day 28

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=553 Participants 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.	Standard Control Plasma n=544 Participants 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.
Number of Participants With Resolved COVID-19 Symptoms at Day 28	250 Participants	245 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 90

Population: All participants who were transfused and had symptom data for day 90

Number of participants with resolved COVID-19 symptoms at day 90

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=533 Participants 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.	Standard Control Plasma n=528 Participants 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.
Number of Participants With Resolved COVID-19 Symptoms at Day 90	359 Participants	347 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to Day 90

Population: Includes patients who were randomized and received transfusion

Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups \<65 and \>=65

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=592 Participants 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.	Standard Control Plasma n=589 Participants 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.
Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate Age group < 65 · Primary event of hospitalization	12 Participants	29 Participants
Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate Age group < 65 · No primary event of hospitalization	540 Participants	520 Participants
Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate Age group >= 65 · Primary event of hospitalization	5 Participants	8 Participants
Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate Age group >= 65 · No primary event of hospitalization	35 Participants	32 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to Day28

Population: Analysis limited to those that had the donor titer measured

Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 Convalescent Plasma n=302 Participants 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.	Standard Control Plasma n=264 Participants 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.
Impact of Donor Antibody Titers on Hospitalization Rate of Convalescent Plasma Recipients Hospitalized	6 Participants	10 Participants
Impact of Donor Antibody Titers on Hospitalization Rate of Convalescent Plasma Recipients Not hospitalized	296 Participants	254 Participants

Adverse Events

SARS-CoV-2 Convalescent Plasma

Serious events: 34 serious events

Other events: 106 other events

Deaths: 0 deaths

Standard Control Plasma

Serious events: 55 serious events

Other events: 109 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

David J. Sullivan

Johns Hopkins University Bloomberg School of Public Health

Phone: 410-502-2522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SARS-CoV-2 Convalescent Plasma n=592 participants at risk 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.	Standard Control Plasma n=589 participants at risk 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.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Cardiac disorders Chest pain - cardiac	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Gastrointestinal disorders Gastric ulcer	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.00% 0/589 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Gastrointestinal disorders Pancreatitis	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Gastrointestinal disorders Vomiting	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
General disorders Non-cardiac chest pain	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Infections and infestations Bronchial infection	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Infections and infestations Kidney Infection	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Infections and infestations Pneumonia	2.4% 14/592 • Number of events 14 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	5.3% 31/589 • Number of events 31 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Injury, poisoning and procedural complications Infusion related reaction	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Investigations Neutrophil count decreased	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Investigations White blood cell decreased	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Metabolism and nutrition disorders Hyperglycemia	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.00% 0/589 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Nervous system disorders Headache	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Nervous system disorders Syncope	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.00% 0/589 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Nervous system disorders Vasovagal reaction	0.68% 4/592 • Number of events 4 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.34% 2/589 • Number of events 2 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Psychiatric disorders Depression	0.34% 2/592 • Number of events 2 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.00% 0/589 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Psychiatric disorders Hallucinations	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.00% 0/589 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Renal and urinary disorders Renal calculi	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Respiratory, thoracic and mediastinal disorders Aspiration	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.00% 0/589 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.51% 3/589 • Number of events 3 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.34% 2/589 • Number of events 2 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Vascular disorders Flushing	0.17% 1/592 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.00% 0/589 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Vascular disorders Hypertension	0.34% 2/592 • Number of events 2 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Vascular disorders Hypotension	0.00% 0/592 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.17% 1/589 • Number of events 1 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
Vascular disorders Thromboembolic event	0.34% 2/592 • Number of events 2 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.	0.00% 0/589 • 90 days We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.