Obiettivo The objective of this proposal is to urgently determine the efficacy, safety and feasibility of convalescent whole blood (CWB) and convalescent plasma (CP) therapy, as a treatment for patients with Ebola Viral Disease (EVD) to reduce the case fatality rate in the present EVD epidemic in West Africa. The trial will take place in three consecutive phases; i) initial phase to initiate harmonized standard supportive care (SC), ii) evaluation of CWB iii) evaluation of CP. Supportive care (SC) including intravenous hydration and shock management will be standardised and made available to all patients. Day 14 mortality will be used to determine primary outcome. Survival for patients treated with CWB + SC or CP + SC will be compared to SC alone using a non-randomised open-label design. Based on available figures, a 20% decrease in the case fatality rate will be considered proof of clinical efficacy. Internationally agreed stands of ethics and human rights will be applied for the duration of the trial. Written consent will be requested from patients and/or guardians of patients. Every consideration will be given to the safely of health-care workers involved in the trial, including their consent to be involved and adequate training and psycho-emotional support. Given the study context, community communication will be prioritized. We propose a unique partnership of academics, clinical trial units, non-governmental organizations, international research networks, international and local actors to conduct a clinical trial according to the highest standards attainable in the current context. If found to be effective, this intervention can be scaled-up relatively rapidly as the trial will provide the information required to mobilize local partners, with major public health implications. Campo scientifico medical and health scienceshealth sciencespublic healthsocial sciencessociologydemographymortalitysocial sciencespolitical sciencespolitical policiescivil societynongovernmental organizationsnatural sciencesbiological sciencesmicrobiologyvirologymedical and health scienceshealth sciencesinfectious diseasesRNA virusesebola Programma(i) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme Argomento(i) Health - Health Invito a presentare proposte H2020-Adhoc-2014-20 Vedi altri progetti per questo bando Meccanismo di finanziamento RIA - Research and Innovation action Coordinatore INSTITUUT VOOR TROPISCHE GENEESKUNDE Contribution nette de l'UE € 1 803 778,45 Indirizzo NATIONALESTRAAT 155 2000 ANTWERPEN Belgio Mostra sulla mappa Regione Vlaams Gewest Prov. Antwerpen Arr. Antwerpen Tipo di attività Higher or Secondary Education Establishments Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 1 907 477,04 Partecipanti (7) Classifica in ordine alfabetico Classifica per Contributo netto dell'UE Espandi tutto Riduci tutto THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD Regno Unito Contribution nette de l'UE € 49 100,00 Indirizzo WELLINGTON SQUARE UNIVERSITY OFFICES OX1 2JD Oxford Mostra sulla mappa Regione South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire Tipo di attività Higher or Secondary Education Establishments Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 88 658,75 THE UNIVERSITY OF LIVERPOOL Regno Unito Contribution nette de l'UE € 85 180,00 Indirizzo BROWNLOW HILL 765 FOUNDATION BUILDING L69 7ZX Liverpool Mostra sulla mappa Regione North West (England) Merseyside Liverpool Tipo di attività Higher or Secondary Education Establishments Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 85 180,00 LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER Regno Unito Contribution nette de l'UE € 60 110,00 Indirizzo KEPPEL STREET WC1E 7HT London Mostra sulla mappa Regione London Inner London — West Camden and City of London Tipo di attività Higher or Secondary Education Establishments Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 60 110,00 UNIVERSITE D'AIX MARSEILLE Francia Contribution nette de l'UE € 218 151,25 Indirizzo BOULEVARD CHARLES LIVON 58 LE PHARO 13284 Marseille Mostra sulla mappa Regione Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Bouches-du-Rhône Tipo di attività Higher or Secondary Education Establishments Collegamenti Contatta l’organizzazione Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 218 151,25 ETABLISSEMENT FRANCAIS DU SANG Francia Contribution nette de l'UE € 385 775,05 Indirizzo AVENUE DU STADE DE FRANCE 20 93210 La Plaine Saint Denis Mostra sulla mappa Regione Ile-de-France Ile-de-France Seine-Saint-Denis Tipo di attività Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 385 775,05 INSTITUT PASTEUR Francia Contribution nette de l'UE € 242 910,00 Indirizzo RUE DU DOCTEUR ROUX 25-28 75724 Paris Mostra sulla mappa Regione Ile-de-France Ile-de-France Paris Tipo di attività Research Organisations Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 242 910,00 INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Francia Contribution nette de l'UE € 47 166,25 Indirizzo RUE DE TOLBIAC 101 75654 Paris Mostra sulla mappa Regione Ile-de-France Ile-de-France Paris Tipo di attività Research Organisations Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 47 166,25