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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 €

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EC-Contrib. €

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Partnership

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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 BE (ANTWERPEN) coordinator 1˙803˙778.00
2    ETABLISSEMENT FRANCAIS DU SANG FR (LA PLAINE SAINT DENIS) participant 385˙775.00
3    INSTITUT PASTEUR FR (PARIS CEDEX 15) participant 242˙910.00
4    UNIVERSITE D'AIX MARSEILLE FR (Marseille) participant 218˙151.00
5    THE UNIVERSITY OF LIVERPOOL UK (LIVERPOOL) participant 85˙180.00
6    LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER UK (LONDON) participant 60˙110.00
7    THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD UK (OXFORD) participant 49˙100.00
8    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE 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

year authors and title journal last update
List of publications.
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.

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