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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.

Coordinator

PRINS LEOPOLD INSTITUUT VOOR TROPISCHE GENEESKUNDE
Net EU contribution
€ 1 803 778,45
Address
Nationalestraat 155
2000 Antwerpen
Belgium

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Region
Vlaams Gewest Prov. Antwerpen Arr. Antwerpen
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 103 698,59

Participants (7)

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
Net EU contribution
€ 49 100,00
Address
Wellington Square University Offices
OX1 2JD Oxford

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Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 39 558,75
THE UNIVERSITY OF LIVERPOOL
United Kingdom
Net EU contribution
€ 85 180,00
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool

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Region
North West (England) Merseyside Liverpool
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER
United Kingdom
Net EU contribution
€ 60 110,00
Address
Keppel Street
WC1E 7HT London

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Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITE D'AIX MARSEILLE
France
Net EU contribution
€ 218 151,25
Address
Boulevard Charles Livon 58 Le Pharo
13284 Marseille

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Region
Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Bouches-du-Rhône
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ETABLISSEMENT FRANCAIS DU SANG
France
Net EU contribution
€ 385 775,05
Address
Avenue Du Stade De France 20
93210 La Plaine Saint Denis

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Region
Ile-de-France Ile-de-France Seine-Saint-Denis
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
INSTITUT PASTEUR
France
Net EU contribution
€ 242 910,00
Address
Rue Du Docteur Roux 25-28
75724 Paris Cedex 15

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
Net EU contribution
€ 47 166,25
Address
Rue De Tolbiac 101
75654 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00