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Ebola_Tx

Emergency evaluation of convalescent blood and plasma for Ebola Viral Disease (EVD) in affected West African countries.

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

Ebola_Tx project word cloud

Explore the words cloud of the Ebola_Tx project. It provides you a very rough idea of what is the project "Ebola_Tx" about.

cp treatment public actors mobilize standardised phases harmonized reduce clinical convalescent supportive human randomised relatively alone urgently intravenous africa efficacy prioritized cwb written community workers intervention attainable requested primary networks care highest hydration epidemic plasma training communication emotional implications label place ebola day guardians found viral survival figures therapy consideration patients consecutive stands sc evd academics standard feasibility evaluation safely outcome internationally health west psycho scaled made initiate standards consent 20 context blood trial fatality initial partnership mortality local proof units 14 rate conduct disease safety ethics agreed international decrease shock rights governmental

Project "Ebola_Tx" data sheet

The following table provides information about the project.

Coordinator	PRINS LEOPOLD INSTITUUT VOOR TROPISCHE GENEESKUNDE Organization address address: Nationalestraat 155 city: ANTWERPEN postcode: 2000 website: www.itg.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Belgium [BE]
Project website	http://www.ebolatx.eu/
Total cost	3˙035˙428 €
EC max contribution	2˙892˙171 € (95%)
Programme	1. H2020-EU.3.1. (SOCIETAL CHALLENGES - Health, demographic change and well-being)
Code Call	H2020-Adhoc-2014-20
Funding Scheme	RIA
Starting year	2014
Duration (year-month-day)	from 2014-11-01 to 2016-10-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	PRINS LEOPOLD INSTITUUT VOOR TROPISCHE GENEESKUNDE PRINS LEOPOLD INSTITUUT VOOR TROPISCHE GENEESKUNDE Organization address address: Nationalestraat 155 city: ANTWERPEN postcode: 2000 website: www.itg.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (ANTWERPEN)	coordinator	1˙803˙778.00
2	ETABLISSEMENT FRANCAIS DU SANG ETABLISSEMENT FRANCAIS DU SANG Organization address address: AVENUE DU STADE DE FRANCE 20 city: LA PLAINE SAINT DENIS postcode: 93210 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (LA PLAINE SAINT DENIS)	participant	385˙775.00
3	INSTITUT PASTEUR INSTITUT PASTEUR Organization address address: RUE DU DOCTEUR ROUX 25-28 city: PARIS CEDEX 15 postcode: 75724 website: http://www.pasteur.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS CEDEX 15)	participant	242˙910.00
4	UNIVERSITE D'AIX MARSEILLE UNIVERSITE D'AIX MARSEILLE Organization address address: Boulevard Charles Livon 58 city: Marseille postcode: 13284 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (Marseille)	participant	218˙151.00
5	THE UNIVERSITY OF LIVERPOOL THE UNIVERSITY OF LIVERPOOL Organization address address: BROWNLOW HILL 765 FOUNDATION BUILDING city: LIVERPOOL postcode: L69 7ZX website: www.liverpool.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LIVERPOOL)	participant	85˙180.00
6	LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER Organization address address: KEPPEL STREET city: LONDON postcode: WC1E 7HT website: http://www.lshtm.ac.uk/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	60˙110.00
7	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD Organization address address: WELLINGTON SQUARE UNIVERSITY OFFICES city: OXFORD postcode: OX1 2JD website: www.ox.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (OXFORD)	participant	49˙100.00
8	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Organization address address: RUE DE TOLBIAC 101 city: PARIS postcode: 75654 website: www.inserm.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	47˙166.00

Map

Project objective

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.

Deliverables

List of deliverables.
Pre-trial anthropological assessments completed	Documents, reports	2019-07-24 14:21:23
Analysis of survival rate of CWB on cohort of 100 patients	Demonstrators, pilots, prototypes	2019-07-24 14:21:23
Comprehensive community mobilization strategy evaluated	Documents, reports	2019-07-24 14:21:24
Scientific publications	Documents, reports	2019-07-24 14:21:24
Qualification of donated blood	Demonstrators, pilots, prototypes	2019-07-24 14:21:24
Registration number of clinical trail acquired.	Documents, reports	2019-07-24 14:21:25
Study protocol finalised, approved and implemented at study site.	Documents, reports	2019-07-24 14:21:24
Comprehensive community mobilization strategy initiated	Demonstrators, pilots, prototypes	2019-07-24 14:21:23
Comprehensive scientific, clinical, strategic and organisational management	Documents, reports	2019-07-24 14:21:24
Monitoring of virological response to treatment	Demonstrators, pilots, prototypes	2019-07-24 14:21:24
Follow-up and management of press and media evaluated	Documents, reports	2019-07-24 14:21:24
Contribution to international and national scientific platforms	Demonstrators, pilots, prototypes	2019-07-24 14:21:24
Analysis of survival rate of patients with standardized supportive care (only).	Demonstrators, pilots, prototypes	2019-07-24 14:21:23
Independent, all-inclusive Data safety management through either an Ebola centralised WHO umbrella group or ad hoc DSMB	Documents, reports	2019-07-24 14:21:24
Ethical approval from overseeing Ethical Committees and Review Boards	Documents, reports	2019-07-24 14:21:25
Results of trial posted on Study Registry including CWB, CP, SC	Documents, reports	2019-07-24 14:21:23
Thorough ethical oversight	Documents, reports	2019-07-24 14:21:24
Optimal standardized supportive care for EVD patients established.	Demonstrators, pilots, prototypes	2019-07-24 14:21:25
Contribution to national (study site) and international EVD health platforms evaluated	Documents, reports	2019-07-24 14:21:24
Analysis of survival rate of CP on cohort of 100 patients	Demonstrators, pilots, prototypes	2019-07-24 14:21:23
Reporting and/or analysis of contingency strategies and/or treatments resulting from unidentified, unforeseen or unavoidable issues which present during the trial period.	Documents, reports	2019-07-24 14:21:23

Take a look to the deliverables list in detail: detailed list of Ebola_Tx deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2016	A. Delamou, N. Y. Haba, A. Mari-Saez, P. Gallian, M. Ronse, J. Jacobs, B. S. Camara, K. J.-J. O. Kadio, A. Guemou, J. P. Kolie, M. D. Crop, P. Chavarin, C. Jacquot, C. Lazaygues, A. D. Weggheleire, L. Lynen, J. van Griensven Organizing the Donation of Convalescent Plasma for a Therapeutic Clinical Trial on Ebola Virus Disease: The Experience in Guinea published pages: 647-653, ISSN: 0002-9637, DOI: 10.4269/ajtmh.15-0890	American Journal of Tropical Medicine and Hygiene 95/3	2019-07-24

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The information about "EBOLA_TX" are provided by the European Opendata Portal: CORDIS opendata.