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

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.

Field of science

  • /medical and health sciences/health sciences/public and environmental health
  • /medical and health sciences/health sciences/infectious disease/RNA virus/ebola
  • /social sciences/law/human rights
  • /social sciences/political science/government systems/nongovernmental organization

Call for proposal

H2020-Adhoc-2014-20
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

PRINS LEOPOLD INSTITUUT VOOR TROPISCHE GENEESKUNDE
Address
Nationalestraat 155
2000 Antwerpen
Belgium
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 803 778,45

Participants (7)

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 49 100
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 85 180
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER
United Kingdom
EU contribution
€ 60 110
Address
Keppel Street
WC1E 7HT London
Activity type
Higher or Secondary Education Establishments
UNIVERSITE D'AIX MARSEILLE
France
EU contribution
€ 218 151,25
Address
Boulevard Charles Livon 58
13284 Marseille
Activity type
Higher or Secondary Education Establishments
ETABLISSEMENT FRANCAIS DU SANG
France
EU contribution
€ 385 775,05
Address
Avenue Du Stade De France 20
93210 La Plaine Saint Denis
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
INSTITUT PASTEUR
France
EU contribution
€ 242 910
Address
Rue Du Docteur Roux 25-28
75724 Paris Cedex 15
Activity type
Research Organisations
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 47 166,25
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations