Convalescent Plasma vs. Standard Plasma for COVID-19
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ClinicalTrials.gov Identifier: NCT04344535 |
Recruitment Status :
Terminated
(Insufficient eligible and consenting patients)
First Posted : April 14, 2020
Results First Posted : December 6, 2021
Last Update Posted : December 6, 2021
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Sponsor:
Stony Brook University
Information provided by (Responsible Party):
Elliott Bennett-Guerrero, Stony Brook University
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
COVID |
Interventions |
Biological: Convalescent Plasma Biological: Standard Donor Plasma |
Enrollment | 82 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | 8 screen failures prior to randomization, thus 74 patients were randomized. |
Arm/Group Title | Convalescent Donor Plasma | Standard Donor Plasma |
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Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma. | Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies |
Period Title: Overall Study | ||
Started | 59 | 15 |
Completed | 59 | 15 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Convalescent Donor Plasma | Standard Donor Plasma | Total | |
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Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma. | Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies | Total of all reporting groups | |
Overall Number of Baseline Participants | 59 | 15 | 74 | |
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[Not Specified]
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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 59 participants | 15 participants | 74 participants | |
67 (15.8) | 64 (17.4) | 66 (16.1) | ||
[1]
Measure Description: years
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 59 participants | 15 participants | 74 participants | |
Female |
23 39.0%
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7 46.7%
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30 40.5%
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Male |
36 61.0%
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8 53.3%
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44 59.5%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | |
0 | ||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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White | Number Analyzed | 59 participants | 15 participants | 74 participants |
42 71.2%
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8 53.3%
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50 67.6%
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Black | Number Analyzed | 59 participants | 15 participants | 74 participants |
5 8.5%
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1 6.7%
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6 8.1%
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Other | Number Analyzed | 59 participants | 15 participants | 74 participants |
12 20.3%
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6 40.0%
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18 24.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Elliott Bennett-Guerrero |
Organization: | Stony Brook University |
Phone: | 6314446026 |
EMail: | elliott.bennett-guerrero@stonybrookmedicine.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Elliott Bennett-Guerrero, Stony Brook University |
ClinicalTrials.gov Identifier: | NCT04344535 |
Other Study ID Numbers: |
SBU-COVID19-ConvalescentPlasma |
First Submitted: | April 10, 2020 |
First Posted: | April 14, 2020 |
Results First Submitted: | September 20, 2021 |
Results First Posted: | December 6, 2021 |
Last Update Posted: | December 6, 2021 |