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Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial
Background: The aim was to evaluate the reinforcement of the standard therapy with hyperimmune plasma (HP) in Coronavirus-19 disease (COVID-19) patients. Methods: Open-label, multicenter, randomized clinical trial performed in three hospitals in the Balearic Islands. Non-severe COVID-19 hospitalized...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9181298/ https://www.ncbi.nlm.nih.gov/pubmed/35683427 http://dx.doi.org/10.3390/jcm11113039 |
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author | Bargay-Lleonart, Joan Sarubbo, Fiorella Arrizabalaga, Maria Guerra, José Maria Borràs, Josep El Haji, Khaoulah Flexas, Magdalena Perales, Jorge Fernández-Baca, Victoria Gallegos, Carmen Cruz, Manuel Raya Velasco, Sonia López, Víctor Cruz, Ana Bautista-Gili, Antonia Jimenez-Marco, Teresa Girona-Llobera, Enric Vilaplana, Laia Calonge, Laura Tena, Juan Galán, Maria Pilar Payeras, Antoni |
author_facet | Bargay-Lleonart, Joan Sarubbo, Fiorella Arrizabalaga, Maria Guerra, José Maria Borràs, Josep El Haji, Khaoulah Flexas, Magdalena Perales, Jorge Fernández-Baca, Victoria Gallegos, Carmen Cruz, Manuel Raya Velasco, Sonia López, Víctor Cruz, Ana Bautista-Gili, Antonia Jimenez-Marco, Teresa Girona-Llobera, Enric Vilaplana, Laia Calonge, Laura Tena, Juan Galán, Maria Pilar Payeras, Antoni |
author_sort | Bargay-Lleonart, Joan |
collection | PubMed |
description | Background: The aim was to evaluate the reinforcement of the standard therapy with hyperimmune plasma (HP) in Coronavirus-19 disease (COVID-19) patients. Methods: Open-label, multicenter, randomized clinical trial performed in three hospitals in the Balearic Islands. Non-severe COVID-19 hospitalized patients with clinical time evolution equal to/less than 7 days were included, and randomized in: plasma group (PG) (n = 37), receiving 600 mL divided into two doses from convalescent plasma donor, administered on days 1 and 2 after the enrollment; and control group (CG) (n = 17). Primary outcome was the time for clinical improvement within 21 days, defined as patient achievement of categories 8, 7, and 6 in the Adaptive COVID-19 Treatment Trial scale (ACTT). The trial was terminated early due to the impossibility of recruitment due to the pandemic. Results: PG presented better scores on the ACTT scale at 7 days after HP infusion, whereas CG was needed 14 days to achieve similar results. The plasma infusion was safe. Conclusions: Despite the tendency observed in the plasma group to achieve slightly earlier better physical condition compared with the standard treatment alone. The administration of HP has been shown to be a safe therapy. No robust evidence was found to affirm a therapeutic effect of the early administration of two infusions of HP for non-severe COVID-19 infected patients. The interpretation is limited by the early termination of the trial, which resulted in a small sample size. |
format | Online Article Text |
id | pubmed-9181298 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-91812982022-06-10 Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial Bargay-Lleonart, Joan Sarubbo, Fiorella Arrizabalaga, Maria Guerra, José Maria Borràs, Josep El Haji, Khaoulah Flexas, Magdalena Perales, Jorge Fernández-Baca, Victoria Gallegos, Carmen Cruz, Manuel Raya Velasco, Sonia López, Víctor Cruz, Ana Bautista-Gili, Antonia Jimenez-Marco, Teresa Girona-Llobera, Enric Vilaplana, Laia Calonge, Laura Tena, Juan Galán, Maria Pilar Payeras, Antoni J Clin Med Article Background: The aim was to evaluate the reinforcement of the standard therapy with hyperimmune plasma (HP) in Coronavirus-19 disease (COVID-19) patients. Methods: Open-label, multicenter, randomized clinical trial performed in three hospitals in the Balearic Islands. Non-severe COVID-19 hospitalized patients with clinical time evolution equal to/less than 7 days were included, and randomized in: plasma group (PG) (n = 37), receiving 600 mL divided into two doses from convalescent plasma donor, administered on days 1 and 2 after the enrollment; and control group (CG) (n = 17). Primary outcome was the time for clinical improvement within 21 days, defined as patient achievement of categories 8, 7, and 6 in the Adaptive COVID-19 Treatment Trial scale (ACTT). The trial was terminated early due to the impossibility of recruitment due to the pandemic. Results: PG presented better scores on the ACTT scale at 7 days after HP infusion, whereas CG was needed 14 days to achieve similar results. The plasma infusion was safe. Conclusions: Despite the tendency observed in the plasma group to achieve slightly earlier better physical condition compared with the standard treatment alone. The administration of HP has been shown to be a safe therapy. No robust evidence was found to affirm a therapeutic effect of the early administration of two infusions of HP for non-severe COVID-19 infected patients. The interpretation is limited by the early termination of the trial, which resulted in a small sample size. MDPI 2022-05-27 /pmc/articles/PMC9181298/ /pubmed/35683427 http://dx.doi.org/10.3390/jcm11113039 Text en © 2022 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 Bargay-Lleonart, Joan Sarubbo, Fiorella Arrizabalaga, Maria Guerra, José Maria Borràs, Josep El Haji, Khaoulah Flexas, Magdalena Perales, Jorge Fernández-Baca, Victoria Gallegos, Carmen Cruz, Manuel Raya Velasco, Sonia López, Víctor Cruz, Ana Bautista-Gili, Antonia Jimenez-Marco, Teresa Girona-Llobera, Enric Vilaplana, Laia Calonge, Laura Tena, Juan Galán, Maria Pilar Payeras, Antoni Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
title | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
title_full | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
title_fullStr | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
title_full_unstemmed | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
title_short | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
title_sort | reinforcement of the standard therapy with two infusions of convalescent plasma for patients with covid-19: a randomized clinical trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9181298/ https://www.ncbi.nlm.nih.gov/pubmed/35683427 http://dx.doi.org/10.3390/jcm11113039 |
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