Convalescent Plasma to Limit Coronavirus Associated Complications
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|ClinicalTrials.gov Identifier: NCT04325672|
Recruitment Status : Withdrawn (Study stopped due to opening Expanded Access Protocol.)
First Posted : March 27, 2020
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus||Biological: Convalescent Plasma||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Convalescent Plasma Group
Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of >1:64.
Biological: Convalescent Plasma
Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers >1:64.
- RNA in SARS-CoV-2 [ Time Frame: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion ]Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
- ICU Admissions [ Time Frame: 90 days after transfusion ]Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
- Hospital Mortality [ Time Frame: 90 days after transfusion ]Total number of subject deaths.
- Hospital Length of Stay (LOS) [ Time Frame: 90 days after transfusion ]The total number of days subjects were admitted to the hospital.
- Type of respiratory support [ Time Frame: 90 days after transfusion or until hospital discharge (whichever comes first) ]The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.
- Duration of respiratory support [ Time Frame: 90 days after transfusion or until hospital discharge (whichever comes first) ]The total number of days subjects required respiratory support.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325672
|Principal Investigator:||Michael Joyner, MD||Mayo Clinic|