Significantly Decreased Mortality in a Large Cohort of Coronavirus Disease 2019 (COVID-19) Patients Transfused Early with Convalescent Plasma Containing High-Titer Anti–Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike Protein IgG
Salazar et al.,
Significantly Decreased Mortality in a Large Cohort of Coronavirus Disease 2019 (COVID-19) Patients Transfused..,
The American Journal of Pathology, doi:10.1016/j.ajpath.2020.10.008
Convalescent plasma study also showing mortality based on HCQ treatment, unadjusted hazard ratio uHR 1.37,
p = 0.28.
Confounding by indication is likely.
This study is excluded in the after exclusion results of meta
analysis:
substantial unadjusted
confounding by indication likely; unadjusted results with no group details.
risk of death, 37.0% higher, RR 1.37, p = 0.28, treatment 12 of 92 (13.0%), control 80 of 811 (9.9%).
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Salazar et al., 4 Nov 2020, retrospective, USA, peer-reviewed, 19 authors.
Abstract: The American Journal of Pathology, Vol. 191, No. 1, January 2021
ajp.amjpathol.org
IMMUNOPATHOLOGY AND INFECTIOUS DISEASES
Significantly Decreased Mortality in a Large
Cohort of Coronavirus Disease 2019 (COVID-19)
Patients Transfused Early with Convalescent Plasma
Containing High-Titer AntieSevere Acute Respiratory
Syndrome Coronavirus 2 (SARS-CoV-2) Spike Protein IgG
Eric Salazar,*y Paul A. Christensen,* Edward A. Graviss,*z Duc T. Nguyen,z Brian Castillo,* Jian Chen,* Bevin V. Lopez,x
Todd N. Eagar,*y Xin Yi,*y Picheng Zhao,* John Rogers,* Ahmed Shehabeldin,* David Joseph,* Faisal Masud,{
Christopher Leveque,* Randall J. Olsen,*yz David W. Bernard,*y Jimmy Gollihar,k and James M. Musser*yz
From the Departments of Pathology and Genomic Medicine* and Anesthesiology and Critical Care,{ Houston Methodist Hospital, Houston, Texas; the
Department of Pathology and Laboratory Medicine,y Weill Cornell Medical College, New York, New York; the Center for Molecular and Translational Human
Infectious Diseasesz and the Academic Office of Clinical Trials,x Houston Methodist Research Institute, Houston, Texas; and the The Combat Capabilities
Development Command Army Research Laboratory-South,k University of Texas at Austin, Austin, Texas
Accepted for publication
October 28, 2020.
Address correspondence to James
M. Musser, M.D., Ph.D., 6565
Fannin St., Suite B490, Houston,
TX 77030. E-mail: jmmusser@
houstonmethodist.org.
Coronavirus disease 2019 (COVID-19) convalescent plasma has emerged as a promising therapy and has
been granted Emergency Use Authorization by the US Food and Drug Administration for hospitalized
COVID-19 patients. We recently reported results from interim analysis of a propensity scoreematched
study suggesting that early treatment of COVID-19 patients with convalescent plasma containing hightiter anti-spike protein receptor binding domain (RBD) IgG significantly decreases mortality. We herein
present results from a 60-day follow-up of a cohort of 351 transfused hospitalized patients. Prospective
determination of enzyme-linked immunosorbent assay anti-RBD IgG titer facilitated selection and
transfusion of the highest titer units available. Retrospective analysis by the Ortho VITROS IgG assay
revealed a median signal/cutoff ratio of 24.0 for transfused units, a value far exceeding the recent US
Food and Drug Administrationerequired cutoff of 12.0 for designation of high-titer convalescent
plasma. With respect to altering mortality, our analysis identified an optimal window of 44 hours after
hospitalization for transfusing COVID-19 patients with high-titer convalescent plasma. In the aggregate, the analysis confirms and extends our previous preliminary finding that transfusion of COVID-19
patients soon after hospitalization with high-titer anti-spike protein RBD IgG present in convalescent
plasma significantly reduces mortality. (Am J Pathol 2021, 191: 90e107; https://doi.org/10.1016/
j.ajpath.2020.10.008)
Coronavirus disease 2019 (COVID-19), caused by severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has
caused massive societal disruption and death globally. As of
September 27, 2020, there have been >33 million COVID-19
cases, causing in excess of 1,000,000 deaths worldwide.1 The
United States has many areas where rising case rates continue
to threaten multiple populations. Few effective treatments
exist (https://www.covid19treatmentguidelines.nih.gov, last
accessed September 24, 2020), in spite of hundreds of
ongoing..
Late treatment
is less effective
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