Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Donato, Michele L., Park, Steven, Baker, Melissa, Korngold, Robert, Morawski, Alison, Geng, Xue, Tan, Ming, Ip, Andrew, Goldberg, Stuart, Rowley, Scott, Chow, Kar, Brown, Emily, Zenreich, Joshua, McKiernan, Phyllis, Buttner, Kathryn, Ullrich, Anna, Long, Laura, Feinman, Rena, Ricourt, Andrea, Kemp, Marlo, Vendivil, Mariefel, Suh, Hyung, Balani, Bindu, Cicogna, Cristina, Sebti, Rani, Al-Khan, Abdulla, Sperber, Steven, Desai, Samit, Fanning, Stacey, Arad, Danit, Go, Ronaldo, Tam, Elizabeth, Rose, Keith, Sadikot, Sean, Siegel, David, Gutierrez, Martin, Feldman, Tatyana, Goy, Andre, Pecora, Andrew, Biran, Noa, Leslie, Lori, Gillio, Alfred, Timmapuri, Sarah, Boonstra, Michele, Singer, Sam, Kaur, Sukhdeep, Richards, Ernest, Perlin, David S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society for Clinical Investigation 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8026191/
https://www.ncbi.nlm.nih.gov/pubmed/33571168
http://dx.doi.org/10.1172/jci.insight.143196
_version_ 1783675628622446592
author Donato, Michele L.
Park, Steven
Baker, Melissa
Korngold, Robert
Morawski, Alison
Geng, Xue
Tan, Ming
Ip, Andrew
Goldberg, Stuart
Rowley, Scott
Chow, Kar
Brown, Emily
Zenreich, Joshua
McKiernan, Phyllis
Buttner, Kathryn
Ullrich, Anna
Long, Laura
Feinman, Rena
Ricourt, Andrea
Kemp, Marlo
Vendivil, Mariefel
Suh, Hyung
Balani, Bindu
Cicogna, Cristina
Sebti, Rani
Al-Khan, Abdulla
Sperber, Steven
Desai, Samit
Fanning, Stacey
Arad, Danit
Go, Ronaldo
Tam, Elizabeth
Rose, Keith
Sadikot, Sean
Siegel, David
Gutierrez, Martin
Feldman, Tatyana
Goy, Andre
Pecora, Andrew
Biran, Noa
Leslie, Lori
Gillio, Alfred
Timmapuri, Sarah
Boonstra, Michele
Singer, Sam
Kaur, Sukhdeep
Richards, Ernest
Perlin, David S.
author_facet Donato, Michele L.
Park, Steven
Baker, Melissa
Korngold, Robert
Morawski, Alison
Geng, Xue
Tan, Ming
Ip, Andrew
Goldberg, Stuart
Rowley, Scott
Chow, Kar
Brown, Emily
Zenreich, Joshua
McKiernan, Phyllis
Buttner, Kathryn
Ullrich, Anna
Long, Laura
Feinman, Rena
Ricourt, Andrea
Kemp, Marlo
Vendivil, Mariefel
Suh, Hyung
Balani, Bindu
Cicogna, Cristina
Sebti, Rani
Al-Khan, Abdulla
Sperber, Steven
Desai, Samit
Fanning, Stacey
Arad, Danit
Go, Ronaldo
Tam, Elizabeth
Rose, Keith
Sadikot, Sean
Siegel, David
Gutierrez, Martin
Feldman, Tatyana
Goy, Andre
Pecora, Andrew
Biran, Noa
Leslie, Lori
Gillio, Alfred
Timmapuri, Sarah
Boonstra, Michele
Singer, Sam
Kaur, Sukhdeep
Richards, Ernest
Perlin, David S.
author_sort Donato, Michele L.
collection PubMed
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.
format Online
Article
Text
id pubmed-8026191
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher American Society for Clinical Investigation
record_format MEDLINE/PubMed
spelling pubmed-80261912021-04-13 Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma Donato, Michele L. Park, Steven Baker, Melissa Korngold, Robert Morawski, Alison Geng, Xue Tan, Ming Ip, Andrew Goldberg, Stuart Rowley, Scott Chow, Kar Brown, Emily Zenreich, Joshua McKiernan, Phyllis Buttner, Kathryn Ullrich, Anna Long, Laura Feinman, Rena Ricourt, Andrea Kemp, Marlo Vendivil, Mariefel Suh, Hyung Balani, Bindu Cicogna, Cristina Sebti, Rani Al-Khan, Abdulla Sperber, Steven Desai, Samit Fanning, Stacey Arad, Danit Go, Ronaldo Tam, Elizabeth Rose, Keith Sadikot, Sean Siegel, David Gutierrez, Martin Feldman, Tatyana Goy, Andre Pecora, Andrew Biran, Noa Leslie, Lori Gillio, Alfred Timmapuri, Sarah Boonstra, Michele Singer, Sam Kaur, Sukhdeep Richards, Ernest Perlin, David S. JCI Insight Research Article 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. American Society for Clinical Investigation 2021-03-22 /pmc/articles/PMC8026191/ /pubmed/33571168 http://dx.doi.org/10.1172/jci.insight.143196 Text en © 2021 Donato et al. https://creativecommons.org/licenses/by/4.0/This work is licensed under the Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Research Article
Donato, Michele L.
Park, Steven
Baker, Melissa
Korngold, Robert
Morawski, Alison
Geng, Xue
Tan, Ming
Ip, Andrew
Goldberg, Stuart
Rowley, Scott
Chow, Kar
Brown, Emily
Zenreich, Joshua
McKiernan, Phyllis
Buttner, Kathryn
Ullrich, Anna
Long, Laura
Feinman, Rena
Ricourt, Andrea
Kemp, Marlo
Vendivil, Mariefel
Suh, Hyung
Balani, Bindu
Cicogna, Cristina
Sebti, Rani
Al-Khan, Abdulla
Sperber, Steven
Desai, Samit
Fanning, Stacey
Arad, Danit
Go, Ronaldo
Tam, Elizabeth
Rose, Keith
Sadikot, Sean
Siegel, David
Gutierrez, Martin
Feldman, Tatyana
Goy, Andre
Pecora, Andrew
Biran, Noa
Leslie, Lori
Gillio, Alfred
Timmapuri, Sarah
Boonstra, Michele
Singer, Sam
Kaur, Sukhdeep
Richards, Ernest
Perlin, David S.
Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma
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 Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8026191/
https://www.ncbi.nlm.nih.gov/pubmed/33571168
http://dx.doi.org/10.1172/jci.insight.143196
work_keys_str_mv AT donatomichelel clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT parksteven clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT bakermelissa clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT korngoldrobert clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT morawskialison clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT gengxue clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT tanming clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT ipandrew clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT goldbergstuart clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT rowleyscott clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT chowkar clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT brownemily clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT zenreichjoshua clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT mckiernanphyllis clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT buttnerkathryn clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT ullrichanna clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT longlaura clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT feinmanrena clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT ricourtandrea clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT kempmarlo clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT vendivilmariefel clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT suhhyung clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT balanibindu clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT cicognacristina clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT sebtirani clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT alkhanabdulla clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT sperbersteven clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT desaisamit clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT fanningstacey clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT araddanit clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT goronaldo clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT tamelizabeth clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT rosekeith clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT sadikotsean clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT siegeldavid clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT gutierrezmartin clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT feldmantatyana clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT goyandre clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT pecoraandrew clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT birannoa clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT leslielori clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT gillioalfred clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT timmapurisarah clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT boonstramichele clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT singersam clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT kaursukhdeep clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT richardsernest clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma
AT perlindavids clinicalandlaboratoryevaluationofpatientswithsarscov2pneumoniatreatedwithhightiterconvalescentplasma