Pathogen reduction with methylene blue does not have an impact on the clinical effectiveness of COVID-19 convalescent plasma.

Carlos Sola Lapeña, Rafael F Duarte, Cristina Avendaño-Solá, Ana Velasco-Iglesias, Antonio Ramos-Martínez, Mayte Pérez-Olmeda, Martín Rubio Batllés, María Elena Madrigal Sánchez, Margarita Berberana Fernández, Luisa Guerra Domínguez, Irene Romera Martínez, Cristina Arbona Castaño, Laura Analía Maglio, Elena Flores Ballester, Isabel Sáez Serrano, José Antonio García Erce, Carolina Villegas Da Ros, Juan Carlos López Aguilar, José María Domingo-Morera, José Luis Bueno Cabrera

Journal: Vox sanguinis 2023;118(4):296-300

PMID: 36734378

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Abstract

BACKGROUND AND OBJECTIVES

There is a concern about a possible deleterious effect of pathogen reduction (PR) with methylene blue (MB) on the function of immunoglobulins of COVID-19 convalescent plasma (CCP). We have evaluated whether MB-treated CCP is associated with a poorer clinical response compared to other inactivation systems at the ConPlas-19 clinical trial.

MATERIALS AND METHODS

This was an ad hoc sub-study of the ConPlas-19 clinical trial comparing the proportion of patients transfused with MB-treated CCP who had a worsening of respiration versus those treated with amotosalen (AM) or riboflavin (RB).

RESULTS

One-hundred and seventy-five inpatients with SARS-CoV-2 pneumonia were transfused with a single CCP unit. The inactivation system of the CCP units transfused was MB in 90 patients (51.4%), RB in 60 (34.3%) and AM in 25 (14.3%). Five out of 90 patients (5.6%) transfused with MB-treated CCP had worsening respiration compared to 9 out of 85 patients (10.6%) treated with alternative PR methods (p = 0.220). Of note, MB showed a trend towards a lower rate of respiratory progressions at 28 days (risk ratio, 0.52; 95% confidence interval, 0.18-1.50).

CONCLUSION

Our data suggest that MB-treated CCP does not provide a worse clinical outcome compared to the other PR methods for the treatment of COVID-19.

Address: Department of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.; Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, Madrid, Spain.; Banco de Sangre y Tejidos de Aragón, Zaragoza, Spain.; Centro de Transfusión de las Fuerzas Armadas, Madrid, Spain.; Department of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain.; Banco de Sangre y Tejidos de Navarra, Servicio Navarro de Salud, Osasunbidea, Pamplona, Spain.; Grupo Español de Rehabilitación Multimodal (GERM), Instituto Aragonés de Ciencias de la Salud, Zaragoza, Spain.; PBM Group, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.; Department of Hematology, Hospital Universitario Clínico San Carlos, Madrid, Spain.; Department of Hematology, Hospital Universitario Príncipe de Asturias, Madrid, Spain.; Banco de Sangre y Tejidos de Manresa, Barcelona, Spain.; Centro de Transfusión de la Comunidad Valenciana, Valencia, Spain.; Centro de Transfusión-Banco de Sangre de La Rioja, Logroño, Spain.; Department of Hematology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas, Spain.; Department of Hematology, Hospital Universitario Severo Ochoa, Madrid, Spain.; Centro de Transfusión de Ciudad Real, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.; Centro Transfusión de Albacete y Cuenca, Albacete, Spain.; Laboratorio de Serología, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Madrid, Spain.; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.; Infectious Diseases Unit, Department of Internal Medicine, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.; Spanish Clinical Research Network (ISCIII), IIS -Hospital Puerta de Hierro-Segovia de Arana, Madrid, Spain.; Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.; Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, SCReN Clinical Trials Platform, Madrid, Spain.

DOI: 10.1111/vox.13406