Resumen
Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Methods: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Conclusions: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.
| Idioma original | Inglés |
|---|---|
| Número de artículo | 1170 |
| Publicación | BMC Infectious Diseases |
| Volumen | 21 |
| N.º | 1 |
| DOI | |
| Estado | Publicada - dic. 2021 |
Nota bibliográfica
Publisher Copyright:© 2021, The Author(s).
ASJC Scopus Subject Areas
- Enfermedades infecciosas
Acceder al documento
Otros archivos y enlaces
Citar esto
- APA
- Standard
- Harvard
- Vancouver
- Author
- BIBTEX
- RIS
En: BMC Infectious Diseases, Vol. 21, N.º 1, 1170, 12.2021.
Producción científica: Contribución a una revista › Artículo › revisión exhaustiva
}
TY - JOUR
T1 - Association between convalescent plasma treatment and mortality in COVID-19
T2 - a collaborative systematic review and meta-analysis of randomized clinical trials
AU - Axfors, Cathrine
AU - Janiaud, Perrine
AU - Schmitt, Andreas M.
AU - van’t Hooft, Janneke
AU - Smith, Emily R.
AU - Haber, Noah A.
AU - Abayomi, Akin
AU - Abduljalil, Manal
AU - Abdulrahman, Abdulkarim
AU - Acosta-Ampudia, Yeny
AU - Aguilar-Guisado, Manuela
AU - Al-Beidh, Farah
AU - Alejandria, Marissa M.
AU - Alfonso, Rachelle N.
AU - Ali, Mohammad
AU - AlQahtani, Manaf
AU - AlZamrooni, Alaa
AU - Anaya, Juan Manuel
AU - Ang, Mark Angelo C.
AU - Aomar, Ismael F.
AU - Argumanis, Luis E.
AU - Averyanov, Alexander
AU - Baklaushev, Vladimir P.
AU - Balionis, Olga
AU - Benfield, Thomas
AU - Berry, Scott
AU - Birocco, Nadia
AU - Bonifacio, Lynn B.
AU - Bowen, Asha C.
AU - Bown, Abbie
AU - Cabello-Gutierrez, Carlos
AU - Camacho, Bernardo
AU - Camacho-Ortiz, Adrian
AU - Campbell-Lee, Sally
AU - Cao, Damon H.
AU - Cardesa, Ana
AU - Carnate, Jose M.
AU - Castillo, German Jr J.
AU - Cavallo, Rossana
AU - Chowdhury, Fazle R.
AU - Chowdhury, Forhad U.H.
AU - Ciccone, Giovannino
AU - Cingolani, Antonella
AU - Climacosa, Fresthel Monica M.
AU - Compernolle, Veerle
AU - Cortez, Carlo Francisco N.
AU - Costa Neto, Abel
AU - D’Antico, Sergio
AU - Daly, James
AU - Danielle, Franca
AU - Davis, Joshua S.
AU - De Rosa, Francesco Giuseppe
AU - Denholm, Justin T.
AU - Denkinger, Claudia M.
AU - Desmecht, Daniel
AU - Díaz-Coronado, Juan C.
AU - Díaz Ponce-Medrano, Juan A.
AU - Donneau, Anne Françoise
AU - Dumagay, Teresita E.
AU - Dunachie, Susanna
AU - Dungog, Cecile C.
AU - Erinoso, Olufemi
AU - Escasa, Ivy Mae S.
AU - Estcourt, Lise J.
AU - Evans, Amy
AU - Evasan, Agnes L.M.
AU - Fareli, Christian J.
AU - Fernandez-Sanchez, Veronica
AU - Galassi, Claudia
AU - Gallo, Juan E.
AU - Garcia, Patricia J.
AU - Garcia, Patricia L.
AU - Garcia, Jesus A.
AU - Garigliany, Mutien
AU - Garza-Gonzalez, Elvira
AU - Gauiran, Deonne Thaddeus V.
AU - Gaviria García, Paula A.
AU - Giron-Gonzalez, Jose Antonio
AU - Gómez-Almaguer, David
AU - Gordon, Anthony C.
AU - Gothot, André
AU - Grass Guaqueta, Jeser Santiago
AU - Green, Cameron
AU - Grimaldi, David
AU - Hammond, Naomi E.
AU - Harvala, Heli
AU - Heralde, Francisco M.
AU - Herrick, Jesica
AU - Higgins, Alisa M.
AU - Hills, Thomas E.
AU - Hines, Jennifer
AU - Holm, Karin
AU - Hoque, Ashraful
AU - Hoste, Eric
AU - Ignacio, Jose M.
AU - Ivanov, Alexander V.
AU - Janssen, Maike
AU - Jennings, Jeffrey H.
AU - Jha, Vivekanand
AU - King, Ruby Anne N.
AU - Kjeldsen-Kragh, Jens
AU - Klenerman, Paul
AU - Kotecha, Aditya
AU - Krapp, Fiorella
AU - Labanca, Luciana
AU - Laing, Emma
AU - Landin-Olsson, Mona
AU - Laterre, Pierre François
AU - Lim, Lyn Li
AU - Lim, Jodor
AU - Ljungquist, Oskar
AU - Llaca-Díaz, Jorge M.
AU - López-Robles, Concepción
AU - López-Cárdenas, Salvador
AU - Lopez-Plaza, Ileana
AU - Lucero, Josephine Anne C.
AU - Lundgren, Maria
AU - Macías, Juan
AU - Maganito, Sandy C.
AU - Malundo, Anna Flor G.
AU - Manrique, Rubén D.
AU - Manzini, Paola M.
AU - Marcos, Miguel
AU - Marquez, Ignacio
AU - Martínez-Marcos, Francisco Javier
AU - Mata, Ana M.
AU - McArthur, Colin J.
AU - McQuilten, Zoe K.
AU - McVerry, Bryan J.
AU - Menon, David K.
AU - Meyfroidt, Geert
AU - Mirasol, Ma Angelina L.
AU - Misset, Benoît
AU - Molton, James S.
AU - Mondragon, Alric V.
AU - Monsalve, Diana M.
AU - Moradi Choghakabodi, Parastoo
AU - Morpeth, Susan C.
AU - Mouncey, Paul R.
AU - Moutschen, Michel
AU - Müller-Tidow, Carsten
AU - Murphy, Erin
AU - Najdovski, Tome
AU - Nichol, Alistair D.
AU - Nielsen, Henrik
AU - Novak, Richard M.
AU - O’Sullivan, Matthew V.N.
AU - Olalla, Julian
AU - Osibogun, Akin
AU - Osikomaiya, Bodunrin
AU - Oyonarte, Salvador
AU - Pardo-Oviedo, Juan M.
AU - Patel, Mahesh C.
AU - Paterson, David L.
AU - Peña-Perez, Carlos A.
AU - Perez-Calatayud, Angel A.
AU - Pérez-Alba, Eduardo
AU - Perkina, Anastasia
AU - Perry, Naomi
AU - Pouladzadeh, Mandana
AU - Poyato, Inmaculada
AU - Price, David J.
AU - Quero, Anne Kristine H.
AU - Rahman, Md M.
AU - Rahman, Md S.
AU - Ramesh, Mayur
AU - Ramírez-Santana, Carolina
AU - Rasmussen, Magnus
AU - Rees, Megan A.
AU - Rego, Eduardo
AU - Roberts, Jason A.
AU - Roberts, David J.
AU - Rodríguez, Yhojan
AU - Rodríguez-Baño, Jesús
AU - Rogers, Benjamin A.
AU - Rojas, Manuel
AU - Romero, Alberto
AU - Rowan, Kathryn M.
AU - Saccona, Fabio
AU - Safdarian, Mehdi
AU - Santos, Maria Clariza M.
AU - Sasadeusz, Joe
AU - Scozzari, Gitana
AU - Shankar-Hari, Manu
AU - Sharma, Gorav
AU - Snelling, Thomas
AU - Soto, Alonso
AU - Tagayuna, Pedrito Y.
AU - Tang, Amy
AU - Tatem, Geneva
AU - Teofili, Luciana
AU - Tong, Steven Y.C.
AU - Turgeon, Alexis F.
AU - Veloso, Januario D.
AU - Venkatesh, Balasubramanian
AU - Ventura-Enriquez, Yanet
AU - Webb, Steve A.
AU - Wiese, Lothar
AU - Wikén, Christian
AU - Wood, Erica M.
AU - Yusubalieva, Gaukhar M.
AU - Zacharowski, Kai
AU - Zarychanski, Ryan
AU - Khanna, Nina
AU - Moher, David
AU - Goodman, Steven N.
AU - Ioannidis, John P.A.
AU - Hemkens, Lars G.
N1 - Publisher Copyright: © 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Methods: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Conclusions: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.
AB - Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Methods: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Conclusions: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.
KW - COVID-19
KW - Convalescent plasma
KW - Meta-analysis
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85119521567&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85119521567&partnerID=8YFLogxK
U2 - 10.1186/s12879-021-06829-7
DO - 10.1186/s12879-021-06829-7
M3 - Article
C2 - 34800996
AN - SCOPUS:85119521567
SN - 1471-2334
VL - 21
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
IS - 1
M1 - 1170
ER -