Cargando…

A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis

COVID-19 is a global pandemic associated with increased morbidity and mortality. Convalescent plasma (CP) infusion is a strategy of potential therapeutic benefit. We conducted a multicenter phase II study to evaluate the efficacy and safety of CP in patients with COVID-19, grade 4 or higher. To eval...

Descripción completa

Detalles Bibliográficos
Autores principales: Pappa, Vasiliki, Bouchla, Anthi, Terpos, Evangelos, Thomopoulos, Thomas P., Rosati, Margherita, Stellas, Dimitris, Antoniadou, Anastasia, Mentis, Andreas, Papageorgiou, Sotirios G., Politou, Marianna, Kotanidou, Anastasia, Kalomenidis, Ioannis, Poulakou, Garyfalia, Jahaj, Edison, Korompoki, Eleni, Grigoropoulou, Sotiria, Hu, Xintao, Bear, Jenifer, Karaliota, Sevasti, Burns, Robert, Pagoni, Maria, Trontzas, Ioannis, Grouzi, Elisavet, Labropoulou, Stavroula, Stamoulis, Kostantinos, Bamias, Aristotelis, Tsiodras, Sotirios, Felber, Barbara K., Pavlakis, George N., Dimopoulos, Meletios- Athanasios
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8069820/
https://www.ncbi.nlm.nih.gov/pubmed/33920489
http://dx.doi.org/10.3390/microorganisms9040806
_version_ 1783683326749442048
author Pappa, Vasiliki
Bouchla, Anthi
Terpos, Evangelos
Thomopoulos, Thomas P.
Rosati, Margherita
Stellas, Dimitris
Antoniadou, Anastasia
Mentis, Andreas
Papageorgiou, Sotirios G.
Politou, Marianna
Kotanidou, Anastasia
Kalomenidis, Ioannis
Poulakou, Garyfalia
Jahaj, Edison
Korompoki, Eleni
Grigoropoulou, Sotiria
Hu, Xintao
Bear, Jenifer
Karaliota, Sevasti
Burns, Robert
Pagoni, Maria
Trontzas, Ioannis
Grouzi, Elisavet
Labropoulou, Stavroula
Stamoulis, Kostantinos
Bamias, Aristotelis
Tsiodras, Sotirios
Felber, Barbara K.
Pavlakis, George N.
Dimopoulos, Meletios- Athanasios
author_facet Pappa, Vasiliki
Bouchla, Anthi
Terpos, Evangelos
Thomopoulos, Thomas P.
Rosati, Margherita
Stellas, Dimitris
Antoniadou, Anastasia
Mentis, Andreas
Papageorgiou, Sotirios G.
Politou, Marianna
Kotanidou, Anastasia
Kalomenidis, Ioannis
Poulakou, Garyfalia
Jahaj, Edison
Korompoki, Eleni
Grigoropoulou, Sotiria
Hu, Xintao
Bear, Jenifer
Karaliota, Sevasti
Burns, Robert
Pagoni, Maria
Trontzas, Ioannis
Grouzi, Elisavet
Labropoulou, Stavroula
Stamoulis, Kostantinos
Bamias, Aristotelis
Tsiodras, Sotirios
Felber, Barbara K.
Pavlakis, George N.
Dimopoulos, Meletios- Athanasios
author_sort Pappa, Vasiliki
collection PubMed
description COVID-19 is a global pandemic associated with increased morbidity and mortality. Convalescent plasma (CP) infusion is a strategy of potential therapeutic benefit. We conducted a multicenter phase II study to evaluate the efficacy and safety of CP in patients with COVID-19, grade 4 or higher. To evaluate the efficacy of CP, a matched propensity score analysis was used comparing the intervention (n = 59) to a control group (n = 59). Sixty patients received CP within a median time of 7 days from symptom onset. During a median follow-up of 28.5 days, 56/60 patients fully recovered and 1 patient remained in the ICU. The death rate in the CP group was 3.4% vs. 13.6% in the control group. By multivariate analysis, CP recipients demonstrated a significantly reduced risk of death [HR: 0.04 (95% CI: 0.004–0.36), p: 0.005], significantly better overall survival by Kaplan–Meir analysis (p < 0.001), and increased probability of extubation [OR: 30.3 (95% CI: 2.64–348.9), p: 0.006]. Higher levels of antibodies in the CP were independently associated with significantly reduced risk of death. CP infusion was safe with only one grade 3 adverse event (AE), which easily resolved. CP used early may be a safe and effective treatment for patients with severe COVID-19 (trial number NCT04408209).
format Online
Article
Text
id pubmed-8069820
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-80698202021-04-26 A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis Pappa, Vasiliki Bouchla, Anthi Terpos, Evangelos Thomopoulos, Thomas P. Rosati, Margherita Stellas, Dimitris Antoniadou, Anastasia Mentis, Andreas Papageorgiou, Sotirios G. Politou, Marianna Kotanidou, Anastasia Kalomenidis, Ioannis Poulakou, Garyfalia Jahaj, Edison Korompoki, Eleni Grigoropoulou, Sotiria Hu, Xintao Bear, Jenifer Karaliota, Sevasti Burns, Robert Pagoni, Maria Trontzas, Ioannis Grouzi, Elisavet Labropoulou, Stavroula Stamoulis, Kostantinos Bamias, Aristotelis Tsiodras, Sotirios Felber, Barbara K. Pavlakis, George N. Dimopoulos, Meletios- Athanasios Microorganisms Article COVID-19 is a global pandemic associated with increased morbidity and mortality. Convalescent plasma (CP) infusion is a strategy of potential therapeutic benefit. We conducted a multicenter phase II study to evaluate the efficacy and safety of CP in patients with COVID-19, grade 4 or higher. To evaluate the efficacy of CP, a matched propensity score analysis was used comparing the intervention (n = 59) to a control group (n = 59). Sixty patients received CP within a median time of 7 days from symptom onset. During a median follow-up of 28.5 days, 56/60 patients fully recovered and 1 patient remained in the ICU. The death rate in the CP group was 3.4% vs. 13.6% in the control group. By multivariate analysis, CP recipients demonstrated a significantly reduced risk of death [HR: 0.04 (95% CI: 0.004–0.36), p: 0.005], significantly better overall survival by Kaplan–Meir analysis (p < 0.001), and increased probability of extubation [OR: 30.3 (95% CI: 2.64–348.9), p: 0.006]. Higher levels of antibodies in the CP were independently associated with significantly reduced risk of death. CP infusion was safe with only one grade 3 adverse event (AE), which easily resolved. CP used early may be a safe and effective treatment for patients with severe COVID-19 (trial number NCT04408209). MDPI 2021-04-11 /pmc/articles/PMC8069820/ /pubmed/33920489 http://dx.doi.org/10.3390/microorganisms9040806 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Pappa, Vasiliki
Bouchla, Anthi
Terpos, Evangelos
Thomopoulos, Thomas P.
Rosati, Margherita
Stellas, Dimitris
Antoniadou, Anastasia
Mentis, Andreas
Papageorgiou, Sotirios G.
Politou, Marianna
Kotanidou, Anastasia
Kalomenidis, Ioannis
Poulakou, Garyfalia
Jahaj, Edison
Korompoki, Eleni
Grigoropoulou, Sotiria
Hu, Xintao
Bear, Jenifer
Karaliota, Sevasti
Burns, Robert
Pagoni, Maria
Trontzas, Ioannis
Grouzi, Elisavet
Labropoulou, Stavroula
Stamoulis, Kostantinos
Bamias, Aristotelis
Tsiodras, Sotirios
Felber, Barbara K.
Pavlakis, George N.
Dimopoulos, Meletios- Athanasios
A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis
title A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis
title_full A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis
title_fullStr A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis
title_full_unstemmed A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis
title_short A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis
title_sort phase ii study on the use of convalescent plasma for the treatment of severe covid-19- a propensity score-matched control analysis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8069820/
https://www.ncbi.nlm.nih.gov/pubmed/33920489
http://dx.doi.org/10.3390/microorganisms9040806
work_keys_str_mv AT pappavasiliki aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT bouchlaanthi aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT terposevangelos aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT thomopoulosthomasp aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT rosatimargherita aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT stellasdimitris aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT antoniadouanastasia aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT mentisandreas aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT papageorgiousotiriosg aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT politoumarianna aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT kotanidouanastasia aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT kalomenidisioannis aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT poulakougaryfalia aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT jahajedison aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT korompokieleni aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT grigoropoulousotiria aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT huxintao aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT bearjenifer aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT karaliotasevasti aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT burnsrobert aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT pagonimaria aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT trontzasioannis aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT grouzielisavet aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT labropouloustavroula aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT stamouliskostantinos aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT bamiasaristotelis aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT tsiodrassotirios aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT felberbarbarak aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT pavlakisgeorgen aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT dimopoulosmeletiosathanasios aphaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT pappavasiliki phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT bouchlaanthi phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT terposevangelos phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT thomopoulosthomasp phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT rosatimargherita phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT stellasdimitris phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT antoniadouanastasia phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT mentisandreas phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT papageorgiousotiriosg phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT politoumarianna phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT kotanidouanastasia phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT kalomenidisioannis phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT poulakougaryfalia phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT jahajedison phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT korompokieleni phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT grigoropoulousotiria phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT huxintao phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT bearjenifer phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT karaliotasevasti phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT burnsrobert phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT pagonimaria phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT trontzasioannis phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT grouzielisavet phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT labropouloustavroula phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT stamouliskostantinos phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT bamiasaristotelis phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT tsiodrassotirios phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT felberbarbarak phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT pavlakisgeorgen phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis
AT dimopoulosmeletiosathanasios phaseiistudyontheuseofconvalescentplasmaforthetreatmentofseverecovid19apropensityscorematchedcontrolanalysis