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Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial
BACKGROUND: COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816149/ https://www.ncbi.nlm.nih.gov/pubmed/33472681 http://dx.doi.org/10.1186/s13063-020-05011-9 |
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author | Diago-Sempere, Elena Bueno, José Luis Sancho-López, Aránzazu Rubio, Elena Múñez Torres, Ferrán de Molina, Rosa Malo Fernández-Cruz, Ana de Diego, Isabel Salcedo Velasco-Iglesias, Ana Payares-Herrera, Concepción Flecha, Inmaculada Casas Avendaño-Solà, Cristina Palomino, Rafael Duarte Ramos-Martínez, Antonio Ruiz-Antorán, Belén |
author_facet | Diago-Sempere, Elena Bueno, José Luis Sancho-López, Aránzazu Rubio, Elena Múñez Torres, Ferrán de Molina, Rosa Malo Fernández-Cruz, Ana de Diego, Isabel Salcedo Velasco-Iglesias, Ana Payares-Herrera, Concepción Flecha, Inmaculada Casas Avendaño-Solà, Cristina Palomino, Rafael Duarte Ramos-Martínez, Antonio Ruiz-Antorán, Belén |
author_sort | Diago-Sempere, Elena |
collection | PubMed |
description | BACKGROUND: COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. METHODS/DESIGN: The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to category 5, 6, or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. DISCUSSION: This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04345523. Registered on 30 March, 2020. First posted date: April 14, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-020-05011-9. |
format | Online Article Text |
id | pubmed-7816149 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-78161492021-01-21 Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial Diago-Sempere, Elena Bueno, José Luis Sancho-López, Aránzazu Rubio, Elena Múñez Torres, Ferrán de Molina, Rosa Malo Fernández-Cruz, Ana de Diego, Isabel Salcedo Velasco-Iglesias, Ana Payares-Herrera, Concepción Flecha, Inmaculada Casas Avendaño-Solà, Cristina Palomino, Rafael Duarte Ramos-Martínez, Antonio Ruiz-Antorán, Belén Trials Study Protocol BACKGROUND: COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. METHODS/DESIGN: The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to category 5, 6, or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. DISCUSSION: This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04345523. Registered on 30 March, 2020. First posted date: April 14, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-020-05011-9. BioMed Central 2021-01-20 /pmc/articles/PMC7816149/ /pubmed/33472681 http://dx.doi.org/10.1186/s13063-020-05011-9 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Diago-Sempere, Elena Bueno, José Luis Sancho-López, Aránzazu Rubio, Elena Múñez Torres, Ferrán de Molina, Rosa Malo Fernández-Cruz, Ana de Diego, Isabel Salcedo Velasco-Iglesias, Ana Payares-Herrera, Concepción Flecha, Inmaculada Casas Avendaño-Solà, Cristina Palomino, Rafael Duarte Ramos-Martínez, Antonio Ruiz-Antorán, Belén Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial |
title | Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial |
title_full | Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial |
title_fullStr | Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial |
title_full_unstemmed | Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial |
title_short | Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial |
title_sort | evaluation of convalescent plasma versus standard of care for the treatment of covid-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816149/ https://www.ncbi.nlm.nih.gov/pubmed/33472681 http://dx.doi.org/10.1186/s13063-020-05011-9 |
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