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Ebola_Tx

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Emergency evaluation of convalescent blood and plasma for Ebola Viral Disease E...

Emergency evaluation of convalescent blood and plasma for Ebola Viral Disease EVD in affected West African countries. 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 red... ver más

31/10/2016

ITM

3M€

Presupuesto del proyecto: 3M€

Líder del proyecto

INSTITUUT VOOR TROPISCHE GENEESKUNDE No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 8 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2016-10-31

DIGITAL-2024-CLOUD-AI-06-HEALTHRECORD: Demonstrating the in-service use of... Expected Outcome:Deliverables

I+D

Cerrada hace 8 meses

0% 95% 100%

Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

8 Participantes

ITM

1.80M€ | Lider

INSERM

47.17K€ | Participante

EFS

385.78K€ | Participante

LSHTM

60.11K€ | Participante

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Duración del proyecto: 22 meses Fecha Inicio: 2014-12-03
Fecha Fin: 2016-10-31

Líder del proyecto

INSTITUUT VOOR TROPISCHE GENEESKUNDE No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 3M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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.

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