Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma

Here, we report on a phase IIa study to determine the intubation rate, survival, viral clearance, and development of endogenous Abs in patients with COVID-19 pneumonia treated with convalescent plasma (CCP) containing high levels of neutralizing anti–SARS-CoV-2 Abs. Radiographic and laboratory evalu...

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Main Authors: Michele L. Donato, Steven Park, Melissa Baker, Robert Korngold, Alison Morawski, Xue Geng, Ming Tan, Andrew Ip, Stuart Goldberg, Scott Rowley, Kar Chow, Emily Brown, Joshua Zenreich, Phyllis McKiernan, Kathryn Buttner, Anna Ullrich, Laura Long, Rena Feinman, Andrea Ricourt, Marlo Kemp, Mariefel Vendivil, Hyung Suh, Bindu Balani, Cristina Cicogna, Rani Sebti, Abdulla Al-Khan, Steven Sperber, Samit Desai, Stacey Fanning, Danit Arad, Ronaldo Go, Elizabeth Tam, Keith Rose, Sean Sadikot, David Siegel, Martin Gutierrez, Tatyana Feldman, Andre Goy, Andrew Pecora, Noa Biran, Lori Leslie, Alfred Gillio, Sarah Timmapuri, Michele Boonstra, Sam Singer, Sukhdeep Kaur, Ernest Richards, David S. Perlin
Format: Article
Language:English
Published: American Society for Clinical investigation 2021-03-01
Series:JCI Insight
Subjects:
Online Access:https://doi.org/10.1172/jci.insight.143196
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author Michele L. Donato
Steven Park
Melissa Baker
Robert Korngold
Alison Morawski
Xue Geng
Ming Tan
Andrew Ip
Stuart Goldberg
Scott Rowley
Kar Chow
Emily Brown
Joshua Zenreich
Phyllis McKiernan
Kathryn Buttner
Anna Ullrich
Laura Long
Rena Feinman
Andrea Ricourt
Marlo Kemp
Mariefel Vendivil
Hyung Suh
Bindu Balani
Cristina Cicogna
Rani Sebti
Abdulla Al-Khan
Steven Sperber
Samit Desai
Stacey Fanning
Danit Arad
Ronaldo Go
Elizabeth Tam
Keith Rose
Sean Sadikot
David Siegel
Martin Gutierrez
Tatyana Feldman
Andre Goy
Andrew Pecora
Noa Biran
Lori Leslie
Alfred Gillio
Sarah Timmapuri
Michele Boonstra
Sam Singer
Sukhdeep Kaur
Ernest Richards
David S. Perlin
author_facet Michele L. Donato
Steven Park
Melissa Baker
Robert Korngold
Alison Morawski
Xue Geng
Ming Tan
Andrew Ip
Stuart Goldberg
Scott Rowley
Kar Chow
Emily Brown
Joshua Zenreich
Phyllis McKiernan
Kathryn Buttner
Anna Ullrich
Laura Long
Rena Feinman
Andrea Ricourt
Marlo Kemp
Mariefel Vendivil
Hyung Suh
Bindu Balani
Cristina Cicogna
Rani Sebti
Abdulla Al-Khan
Steven Sperber
Samit Desai
Stacey Fanning
Danit Arad
Ronaldo Go
Elizabeth Tam
Keith Rose
Sean Sadikot
David Siegel
Martin Gutierrez
Tatyana Feldman
Andre Goy
Andrew Pecora
Noa Biran
Lori Leslie
Alfred Gillio
Sarah Timmapuri
Michele Boonstra
Sam Singer
Sukhdeep Kaur
Ernest Richards
David S. Perlin
author_sort Michele L. Donato
collection DOAJ
description Here, we report on a phase IIa study to determine the intubation rate, survival, viral clearance, and development of endogenous Abs in patients with COVID-19 pneumonia treated with convalescent plasma (CCP) containing high levels of neutralizing anti–SARS-CoV-2 Abs. Radiographic and laboratory evaluation confirmed all 51 treated patients had COVID-19 pneumonia. Fresh or frozen CCP from donors with high titers of neutralizing Abs was administered. The nonmechanically ventilated patients (n = 36) had an intubation rate of 13.9% and a 30-day survival rate of 88.9%, and the overall survival rate for a comparative group based on network data was 72.5% (1625/2241). Patients had negative nasopharyngeal swab rates of 43.8% and 73.0% on days 10 and 30, respectively. Patients mechanically ventilated had a day-30 mortality rate of 46.7%; the mortality rate for a comparative group based on network data was 71.0% (369/520). All evaluable patients were found to have neutralizing Abs on day 3 (n = 47), and all but 1 patient had Abs on days 30 and 60. The only adverse event was a mild rash. In this study on patients with COVID-19 disease, we show therapeutic use of CCP was safe and conferred transfer of Abs, while preserving endogenous immune response.
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spelling doaj.art-4105869b8be542f7861f13287a3a16522022-12-21T21:32:32ZengAmerican Society for Clinical investigationJCI Insight2379-37082021-03-0166Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasmaMichele L. DonatoSteven ParkMelissa BakerRobert KorngoldAlison MorawskiXue GengMing TanAndrew IpStuart GoldbergScott RowleyKar ChowEmily BrownJoshua ZenreichPhyllis McKiernanKathryn ButtnerAnna UllrichLaura LongRena FeinmanAndrea RicourtMarlo KempMariefel VendivilHyung SuhBindu BalaniCristina CicognaRani SebtiAbdulla Al-KhanSteven SperberSamit DesaiStacey FanningDanit AradRonaldo GoElizabeth TamKeith RoseSean SadikotDavid SiegelMartin GutierrezTatyana FeldmanAndre GoyAndrew PecoraNoa BiranLori LeslieAlfred GillioSarah TimmapuriMichele BoonstraSam SingerSukhdeep KaurErnest RichardsDavid S. PerlinHere, we report on a phase IIa study to determine the intubation rate, survival, viral clearance, and development of endogenous Abs in patients with COVID-19 pneumonia treated with convalescent plasma (CCP) containing high levels of neutralizing anti–SARS-CoV-2 Abs. Radiographic and laboratory evaluation confirmed all 51 treated patients had COVID-19 pneumonia. Fresh or frozen CCP from donors with high titers of neutralizing Abs was administered. The nonmechanically ventilated patients (n = 36) had an intubation rate of 13.9% and a 30-day survival rate of 88.9%, and the overall survival rate for a comparative group based on network data was 72.5% (1625/2241). Patients had negative nasopharyngeal swab rates of 43.8% and 73.0% on days 10 and 30, respectively. Patients mechanically ventilated had a day-30 mortality rate of 46.7%; the mortality rate for a comparative group based on network data was 71.0% (369/520). All evaluable patients were found to have neutralizing Abs on day 3 (n = 47), and all but 1 patient had Abs on days 30 and 60. The only adverse event was a mild rash. In this study on patients with COVID-19 disease, we show therapeutic use of CCP was safe and conferred transfer of Abs, while preserving endogenous immune response.https://doi.org/10.1172/jci.insight.143196COVID-19
spellingShingle Michele L. Donato
Steven Park
Melissa Baker
Robert Korngold
Alison Morawski
Xue Geng
Ming Tan
Andrew Ip
Stuart Goldberg
Scott Rowley
Kar Chow
Emily Brown
Joshua Zenreich
Phyllis McKiernan
Kathryn Buttner
Anna Ullrich
Laura Long
Rena Feinman
Andrea Ricourt
Marlo Kemp
Mariefel Vendivil
Hyung Suh
Bindu Balani
Cristina Cicogna
Rani Sebti
Abdulla Al-Khan
Steven Sperber
Samit Desai
Stacey Fanning
Danit Arad
Ronaldo Go
Elizabeth Tam
Keith Rose
Sean Sadikot
David Siegel
Martin Gutierrez
Tatyana Feldman
Andre Goy
Andrew Pecora
Noa Biran
Lori Leslie
Alfred Gillio
Sarah Timmapuri
Michele Boonstra
Sam Singer
Sukhdeep Kaur
Ernest Richards
David S. Perlin
Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma
JCI Insight
COVID-19
title Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma
title_full Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma
title_fullStr Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma
title_full_unstemmed Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma
title_short Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma
title_sort clinical and laboratory evaluation of patients with sars cov 2 pneumonia treated with high titer convalescent plasma
topic COVID-19
url https://doi.org/10.1172/jci.insight.143196
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