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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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Includes participants who were randomized and received transfusion
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
42
(32 to 54)
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44
(33 to 55)
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43
(32 to 54)
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
18 - 34 years |
190 32.1%
|
165 28.0%
|
355 30.1%
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|
35 - 49 years |
207 35.0%
|
208 35.3%
|
415 35.1%
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50 - 64 years |
155 26.2%
|
176 29.9%
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331 28.0%
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>=65 years |
40 6.8%
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40 6.8%
|
80 6.8%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
Female |
323 54.6%
|
352 59.8%
|
675 57.2%
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Male |
269 45.4%
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237 40.2%
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506 42.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
Hispanic or Latino |
80 13.5%
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90 15.3%
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170 14.4%
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Not Hispanic or Latino |
512 86.5%
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499 84.7%
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1011 85.6%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
American Indian or Alaska Native |
8 1.4%
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9 1.5%
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17 1.4%
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Asian |
22 3.7%
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22 3.7%
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44 3.7%
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Native Hawaiian or Other Pacific Islander |
2 0.3%
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2 0.3%
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4 0.3%
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Black or African American |
92 15.5%
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71 12.1%
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163 13.8%
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White |
459 77.5%
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475 80.6%
|
934 79.1%
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More than one race |
9 1.5%
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10 1.7%
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19 1.6%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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BMI category 1
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
<30 |
382 64.5%
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355 60.3%
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737 62.4%
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>=30 |
210 35.5%
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234 39.7%
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444 37.6%
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BMI category 2
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
<35 |
495 83.6%
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482 81.8%
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977 82.7%
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>=35 |
97 16.4%
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107 18.2%
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204 17.3%
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Hypertension
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
Yes |
140 23.6%
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136 23.1%
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276 23.4%
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No |
452 76.4%
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453 76.9%
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905 76.6%
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Diabetes
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
Yes |
49 8.3%
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50 8.5%
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99 8.4%
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No |
543 91.7%
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539 91.5%
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1082 91.6%
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Asthma
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
Yes |
59 10.0%
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73 12.4%
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132 11.2%
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No |
533 90.0%
|
516 87.6%
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1049 88.8%
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HIV infection
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
Yes |
13 2.2%
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12 2.0%
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25 2.1%
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No |
579 97.8%
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577 98.0%
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1156 97.9%
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Pregnant
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
Yes |
2 0.3%
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1 0.2%
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3 0.3%
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No |
590 99.7%
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588 99.8%
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1178 99.7%
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Time from symptom onset to transfusion
Median (Inter-Quartile Range) Unit of measure: Days |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
6
(4 to 7)
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6
(4 to 7)
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6
(4 to 7)
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Vaccine status
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 592 participants | 589 participants | 1181 participants | |
Unvaccinated |
486 82.1%
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479 81.3%
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965 81.7%
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Partially vaccinated |
27 4.6%
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31 5.3%
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58 4.9%
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Fully vaccinated |
79 13.3%
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79 13.4%
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158 13.4%
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Name/Title: | David J. Sullivan |
Organization: | Johns Hopkins University Bloomberg School of Public Health |
Phone: | 410-502-2522 |
EMail: | dsulliv7@jh.edu |
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 |