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

Trials

Study Protocol

Ferrán Torres¹  Concepción Payares-Herrera²  Cristina Avendaño-Solಠ Elena Diago-Sempere²  Aránzazu Sancho-López²  Isabel Salcedo de Diego²  Belén Ruiz-Antorán²  Inmaculada Casas Flecha³  Rafael Duarte Palomino⁴  José Luis Bueno⁵  Ana Velasco-Iglesias⁶  Antonio Ramos-Martínez⁷  Ana Fernández-Cruz⁷  Elena Múñez Rubio⁷  Rosa Malo de Molina⁸ 

[1] Clinical Pharmacology Department, Hospital Clínic Barcelona, Medical Statistics core facility – IDIBAPS, Barcelona, Spain;Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, c/ Manuel de Falla 1, 28222, Madrid, Spain;Flu and Respiratory Virus Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Madrid, Spain;Hematology and Hemotherapy Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain;Hemotherapy & Apheresis Units, Hematology and Hemotherapy Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain;IIS Puerta de Hierro - Segovia de Arana, Madrid, Spain;Internal Medicine Department, Infectious diseases unit, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain;Pneumology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain;

关键词: COVID-19;    Randomized;    Controlled trial;    Protocol;    Convalescent plasma (CP);    Antibodies;    Neutralizing antibodies;    Hospitalized patients;   

DOI  :  10.1186/s13063-020-05011-9

 received in 2020-07-31, accepted in 2020-12-29,  发布年份 2020

来源: Springer

【 摘 要 】

BackgroundCOVID-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/designThe 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.DiscussionThis 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 registrationClinicalTrials.gov NCT04345523. Registered on 30 March, 2020. First posted date: April 14, 2020.

【 授权许可】

CC BY   
© The Author(s). 2021

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