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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.

Fields of science (EuroSciVoc)

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Programme(s)

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Topic(s)

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Funding Scheme

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RIA - Research and Innovation action

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-Adhoc-2014-20

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Coordinator

INSTITUUT VOOR TROPISCHE GENEESKUNDE
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 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
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 907 477,04

Participants (7)

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