Dataset from IGHID 12021 - A Randomized, Phase II Study Comparing the Efficacy and Safety of Standard Versus High-Titer Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody Plasma in Hospitalized Patients With COVID-19
收藏NIAID Data Ecosystem2026-05-10 收录
下载链接:
https://doi.org/10.25934/PR00010059
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资源简介:
The purpose of this research study is to find out if CCP is safe and to determine the safest
and most effective level of anti-viral antibody when given to people admitted to the hospital
with confirmed COVID-19 infection. Participants enrolled on this study will be transfused
with 2 units of CCP through an IV. These units will be given one at a time 4 to 24 hours
apart. Participants will be randomized to receive either 2 units with standard antibody
levels as recommended by the FDA or 2 units with an antibody level higher than that
recommended by the FDA. This study is experimental and CCP is investigational and has not
been approved by the FDA for the treatment of COVID-19. The CCP is collected per FDA
guidelines from persons recovered from COVID-19 infection. The plasma contains antibodies and
possibly other properties that inhibit the virus. The investigators do not know if the level
of antibodies present in the CCP will make a difference in how the participant's body is able
to fight the infection and hope to learn that in this study.
创建时间:
2026-02-06



