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Recruitment Status : Withdrawn (Study stopped due to opening Expanded Access Protocol.)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
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|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients must be 18 years of age or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
- Patient agrees to storage of specimens for future testing.
- Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
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|
|Responsible Party:||Michael J. Joyner, M.D., Principal Investigator, Mayo Clinic|
|Other Study ID Numbers:||
|First Posted:||March 27, 2020 Key Record Dates|
|Last Update Posted:||April 8, 2020|
|Last Verified:||April 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
2019 novel Coronavirus
RNA Virus Infections