Convalescent plasma for preventing critical illness in COVID-19: A phase 2 trial and immune profile
Jeffrey Michael Sturek,
Tania A. Thomas,
James D. Gorham,
Chelsea A. Sheppard,
Allison E. Raymond,
Kristen Petros De Guex,
William B. Harrington,
Andrew J. Barros,
Gregory R. Madden,
Yosra M. Alkabab,
Melinda D. Poulter,
Amy J. Mathers,
Ewa M. Kubicka,
Lawrence G. Lum,
Scott K Heysell
Posted 19 Feb 2021
medRxiv DOI: 10.1101/2021.02.16.21251849
Posted 19 Feb 2021
RationaleThe COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an unprecedented event requiring rapid adaptation to changing clinical circumstances. Convalescent immune plasma (CIP) is a promising treatment that can be mobilized rapidly in a pandemic setting. ObjectivesWe tested whether administration of SARS-CoV-2 CIP at hospital admission could reduce the rate of ICU transfer or 28 day mortality. MethodsIn a single-arm phase II study, patients >18 years-old with respiratory symptoms documented with COVID-19 infection who were admitted to a non-ICU bed were administered two units of CIP within 72 hours of admission. Detection of respiratory tract SARS-CoV-2 by polymerase chain reaction and circulating anti-SARS-CoV-2 antibody titers were measured before and at time points after CIP transfusion. Measurements and Main ResultsTwenty-nine patients were transfused CIP and forty-eight contemporaneous controls were identified with comparable baseline characteristics. Levels of anti-SARS-CoV-2 IgG, IgM, and IgA anti-spike, anti-receptor-binding domain, and anti-nucleocapsid significantly increased from baseline to post-transfusion for all proteins tested. In patients transfused with CIP, the rate of ICU transfer was 13.8% compared to 27.1% for controls with a hazard ratio 0.506 (95% CI 0.165-1.554), and 28-day mortality was 6.9% compared to 10.4% for controls, hazard ratio 0.640 (95% CI 0.124-3.298). ConclusionsTransfusion of high-titer CIP to patients early after admission with COVID-19 respiratory disease was associated with reduced ICU transfer and 28-day mortality but was not statistically significant. Follow up randomized trials may inform the use of CIP for COVID-19 or future coronavirus pandemics.
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