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
Author
Diago-Sempere, Elena; Bueno, José Luis; Sancho-López, Aránzazu; Muñez-Rubio, Elena; Torres, Ferrán; Malo de Molina, Rosa; Fernández-Cruz, Ana; Salcedo de Diego, Isabel



Entity
UAM. Departamento de Farmacología; UAM. Departamento de MedicinaDate
2021-01-20Citation
Trials 22.1 (2021): 70ISSN
1745-6215Funded by
This research is funded by the Government of Spain, Ministry of Science and Innovation, Instituto de Salud Carlos III, grant n° COV20/00072 (Royal Decree-Law 8/2020, of 17 March, on urgent extraordinary measures to deal with the economic and social impact of COVID-19), co-financed by the European Regional Development Fund (FEDER) “A way to make Europe,” and supported by SCReN (Spanish Clinical Research Network), ISCIII, project PT17/0017/0009. The funding institutions do not have any role in the design of the study, data collection, analysis, or interpretation of data, nor in writing the manuscriptProject
Gobierno de España. COV20/00072Editor's Version
https://doi.org/10.1186/s13063-020-05011-9Subjects
COVID-19; Randomized; Controlled trial; Protocol; Convalescent plasma (CP); Antibodies; Neutralizing antibodies; Hospitalized patients; MedicinaNote
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliationsRights
© The Author(s)Abstract
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
Files in this item
Google Scholar:Diago-Sempere, Elena
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Bueno, José Luis
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Sancho-López, Aránzazu
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Muñez-Rubio, Elena
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Torres, Ferrán
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Malo de Molina, Rosa
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Fernández-Cruz, Ana
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Salcedo de Diego, Isabel
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Velasco-Iglesias, Ana
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Payares-Herrera, Concepción
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Casas Flecha, Inmaculada
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Avendaño Solá, Cristina
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Duarte Palomino, Rafael
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Ramos Martínez, Antonio
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Ruiz-Antorán, Belén
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