Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trialResearch in context

Autor: Andrea Alemany, Pere Millat-Martinez, Marc Corbacho-Monné, Clara Suñer, Cristina Galvan-Casas, Caty Carrera, Dan Ouchi, Núria Prat, Jordi Ara, Nuria Nadal, Ricard Riel, Blanca Funollet, Carmen Ojeda-Ciurana, Lluis Esteve Balague, Betlem Salvador-González, Anna Forcada Arcarons, Josep Vidal-Alaball, María Isabel Del Cura-González, Ricardo Rodríguez Barrientos, Rafel Ramos-Blanes, Alberto Alum Bou, Elsa Mondou, Mireia Torres, Neus Campins, Ana Sanz, Yonggiang Tang, Miquel Àngel Rodriguez-Arias, Quique Bassat, Bonaventura Clotet, Oriol Mitjà, Adrià Aguilar-Uroz, Adrià Rosell-García-Ufano, Adrián Escudero Planas, Aida Baelo, Ainhoa Villahoz Martín, Alberto Moreno López, Alberto Roldan Ruiz, Alberto Santana Briongos, Alberto Tejera Bodas, Alejandro Alonso-Vallés, Alejandro Fletes-Pérez, Alejandro Hueso-Mor, Alex Boluda, Alex Santamaria, Alicia Santos Diestro, Almudena Revuelta-Álvarez, Álvaro Moreno Moreno, Ana Ortega de Felipe, Ana Chen-Ye, Ana Blázquez Valerón, Ana Belén Rodríguez Pérez, Ana Laura Tristán Morgalo, Ana Luisa Fernández-Allende, Andrea Bagán-Trejo, Andrés Fernández Juan, Ángel Zalve-Cano, Anna Mateo-Martínez, Antonio Valero Galván, Antonio Egidos-Plaja, Ariadna Jorge, Arturo Fraile Torres, Azahara Maria Pareja Leal, Bárbara Viader Castro, Barbara Fernandez Beato, Barbara Naveira Menchen, Beatriz Martin Poyatos, Beatriz García-Martínez, Belén Rodrigo Testillano, Belen Blanco Tejedor, Blanca López Pérez, Blanca Mencía Hernanz, Camila González-Beiras, Carlos Batres, Carmen Nuñez Garcia, Carmen Merino-Rodríguez, Carolina Rodríguez-Gilabert, Celia Bonilla Penedo, Christian Casado Gomez, Claudia Gonzalez Perez, Claudia Galindo-Tomás, Cristina Peral Bolaños, Cristina Blanco-Montes, Cristina Lupu-Yakovleva, Cristina Lopez Ruiz, Cristina Perez Mayoral, Cristina Fornes, Cristobal Garcia Corrochano, Daniel Gallardo Álvarez, Daniel Navarro Sanz, David Sanz Barrio, Debora Ramet Meseguer, Edna Margarita Vera-Jurado, Eduardo Perez Costa, Eilen Junet Bustillos-Sebastian, Elena Palomar Casado, Elena Dorrego Guerrero, Elena Medina Mateos, Elisa Rebeca Aragón Gaspar, Elisabeth Herrero-Vila, Enriqueta Paez Herrera, Esmeralda Rojas Powel, Esther Robres Medialdea, Esther Vall-Ribalta, Eva Lopez Perez, Felicia Mihaela Fer, Fernanda Vazquez Ángeles, Fernando Tirado Bejarano, Ferran Prats-Domenech, Ferran Borràs Martí, Gabriela Ardila-Mejia, Gèlia Costes, Gema Gómez Arquero, Gemma Flores Mateo, Guillem Pintos-Morell, Helena Mira-Centelles, Ignacio Astola Requena, Ignacio Ortega Martin, Iker Leivas-Gutierrez, Irene Escribano Valenciano, Irene Muñoz Gomez, Irina Ortega, Isabel Montserrat-Lloan, Itziar Gamboa, Jacobo Rodríguez de Torres de Paul, Jordi Cahís, Jordi Muñoz-Martinez, Jorge Iglesias Bermejo, Joselvis Virginia Cejas López, Josep Canudas, Juan Antonio García Lucas, Juan Carlos Martínez-Pino, Juana Torres Martínez, Judit Pujol-Corney, Judith González Jiménez, Júlia Gurí, Julio Labella Martín, Laia Garcia-Cano, Lara Sonsoles Perez Plata, Laura Muñoz Álvaro, Laura Rodríguez Andrés, Laura Vega Ruiz, Laura Cuevas Valiente, Laura Díaz Rodríguez, Laura Puigros, Lavinia Oristina Rciorang, Leticia Escudero, Liliana Figueroa Caballero, Lluna Ferrerfàbrega-Costals, Lucía Costafreda-Hernández, Lucía De-Paúl, Luis González Fernández-Medina, Ma Carmen Moliner Prada, Ma Cristina Berriochoa Martínez de Pisón, Maria Blanco Blasco, Maria Gil Jorge, María Cortijo Caballero, Maria Ubals, Maria Gordillo, Maria Alicia Guilloto López, Maria Concepción Moreno Calvo, María del Rosario Gil García, María Inmaculada Dueñas Román, Maria Josefa Gonzalez Sanchez, María Luisa Nicolás Campoy, Maria Luz González Velayos, Mario Mejías Zori, Mario Oliva Maqueda, Mario Caño de la Cruz, Mariona Palau-Morral, Marta Martín-Muñoz, Marta Cereceda Meca, Marta Díaz Urbina, Martha VerónicaPlazas, Martí Vall-Mayans, Martí Blasco, Mary Jane Chu-Sifuentes, Miguel García de Villasladad Peñaranda, Miguel Hernanz Sotoca, Miguel Iglesias Gonzalez, Miguel Ángel Labrador-Galván, Miguel Rodrigo de Vivar Azcarate, Miquel Gil-Fibla, Miquel Formentí-Pallarés, Mireia Esteve-Tugues, Miriam Juanes Perez, Miriam López Rubio, Mirian Recuero Renales, Mònica Hijós-Rullo, Montserrat Lleonart-Abadia, Nadia Finelli, Naiara Rojas-Bertier, Nataly Reyes-Calderón, Nerea Casado Larrañaga, Nerea Nuria Zurita Castrosin, Noélia Álvarez-Nieto, Nuria Leiva-Mora, Olga Tomillo-Martín, Omar Belghazi, Oriol Buscà, Pablo Mendoza Cediel, Pablo Macedo, Patricia Rodríguez Barroso, Patricia Ruiz Álvarez, Patricia Morales López, Patricia Jimenez Vara de Rey, Paz Lozano Ginés, Pilar Bris Rodriguez, Pilar Martínez-Alamillo, Rafa Salmerón Martínez, Raquel Botello Ariza, Raquel Vaquero Mena, Raquel González-Alonso, Raul Kaczmarczyk, Rita Barnadas Vintró, Rodrigo Hontecillas Martínez, Rosa Ribot-Rodríguez, Rosa Escobar-Sánchez, Rosario Paloma Montes Trinidad, Rubén Martínez Quintana, Ruben Arnay Arrogante, Ruben Berjon Sanchez, Ruben Picazo Navarro, Rubén Bastos, Samuel Martín Molinero, Samuel Dan Israel-Benchaya, Sandra Muñoz-Burguillo, Sandra Rodríguez-Salvador, Sara Avila, Sara Corral Gayubas, Sergio Nuñez Sánchez, Sofía Torres Weber, Susana Encabo Lopez, Teresa Torices Rasines, Valentí Sallas, Verónica Curto-Vicente, Verónica Gómez Hijosa, Verónica Daimiel-Pedrote, Verónica Gozalo, Vicente Barrios López, Virginia Ivette Castillo Montoya, Yuri Espinoza Pérez, María CristinaBerriochoa Martínez de Pisón, David Muñoz Castillo, Carlos Donato, Isabel García García

Publikováno v: EClinicalMedicine, Vol 57, Iss , Pp 101898- (2023)

Summary: Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reporte

Externí odkaz: https://doaj.org/article/f1285e4c1aec4005a0de1e806cb0ea03

Randomized Double-Blind Placebo-Controlled Trial of the Corticosteroid-Sparing Effects of Immunoglobulin in Myasthenia Gravis

Autor: Vera Bril, Andrzej Szczudlik, Antanas Vaitkus, Csilla Rozsa, Anna Kostera-Pruszczyk, Petr Hon, Josef Bednarik, Michaela Tyblova, Wolfgang Köhler, Toomas Toomsoo, Richard J. Nowak, Tahseen Mozaffar, Miriam L. Freimer, Michael W. Nicolle, Tim Magnus, Michael T. Pulley, Michael Rivner, Mazen M. Dimachkie, B. Jane Distad, Robert M. Pascuzzi, Donna Babiar, Jiang Lin, Montse Querolt Coll, Rhonda Griffin, Elsa Mondou

Publikováno v: Neurology, vol 100, iss 7

Background and ObjectivesMyasthenia gravis (MG) is an autoimmune disease characterized by dysfunction at the neuromuscular junction. Treatment frequently includes corticosteroids (CSs) and IV immunoglobulin (IVIG). This study was conducted to determi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f30a5b6044e9a33d39c4bc45f72b6e05
https://doi.org/10.1212/wnl.0000000000201501

Pharmacokinetics, efficacy and safety of a novel fibrinogen concentrate in pediatric patients with congenital afibrinogenemia

Autor: Claudia Djambas Khayat, Jordi Navarro-Puerto, Cecil Reuben Ross, Kannan Subramanian, Nijalingappa K. Kalappanavar, Karen Rucker, Wei Liang, Elsa Mondou

Publikováno v: Blood coagulationfibrinolysis : an international journal in haemostasis and thrombosis.

Congenital afibrinogenemia treatment with plasma-derived fibrinogen concentrates in pediatric patients is limited. This study investigated the pharmacokinetics, surrogate efficacy, and safety of a plasma-derived fibrinogen concentrate (FIB Grifols) i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a54db8639239cff960419bcbbc3cdfe2
https://pubmed.ncbi.nlm.nih.gov/36484281

A Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency

Autor: Manuel Santamaria, Olaf Neth, Jo A. Douglass, Gergely Krivan, Robin Kobbe, Ewa Bernatowska, Sofia Grigoriadou, Claire Bethune, Anita Chandra, Gerd Horneff, Michael Borte, Anja Sonnenschein, Pavlina Kralickova, Silvia Sánchez Ramón, Daman Langguth, Luis Ignacio Gonzalez-Granado, Laia Alsina, Montse Querolt, Rhonda Griffin, Carrie Hames, Elsa Mondou, Jeffrey Price, Ana Sanz, Jiang Lin

[Purpose] The purpose of this phase 3 study was to evaluate the efficacy, pharmacokinetics (PK), and safety of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) in patients with primary immunodeficiency (PI).