Ebola_Tx project deliverables
The page lists 21 deliverables related to the research project "Ebola_Tx".
List of Deliverables
| title and desprition | type | last update |
|---|---|---|
Pre-trial anthropological assessments completedThe cultural and social complexity of a trial of this nature under an unprecedented emergency which has such a high impact on the population cannot be underestimated. The purpose of this assessment is to understand what exists; which platforms are active; what interlinkages are necessary and determine a clear understanding of how the health messages, informed consent and the understanding of the aim, action and output of this trial can be best communicated to and understood by the community. The community and social mobilization and communication plans will be determined by the output of these initial assessments. But anthropological support will be continuous over the the trial period. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Analysis of survival rate of CWB on cohort of 100 patientsAnalysis of the survival rate of the first cohort of 100 patients with clinical and scientific conclusions on the efficacy of CWB for the treatment of EVD during an emergency in poor resource settings. Programme: H2020-EU.3.1. - Topic(s): Health |
Demonstrators, pilots, prototypes | 2019-07-24 |
Comprehensive community mobilization strategy evaluatedWhile this deliverable refers to a final evaluation of the communication strategies and methodologies used during the trial period; this report will include the progressive evaluation and monitoring undertaken during the course of the trial to ensure that messages, strategies and methodologies remained coherent, were reaching the right audience and were consistently imparting accurate, well understood and helpful information that has aided the smooth implementation of this study. Any interlinkages with other existing platforms or Ebola research consortia will also be taken into consideration. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Scientific publicationsRefers to all and any scientific publications that result from any elements of this trial, including after funding period is finished. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Qualification of donated bloodTo provide a report on the full qualification in terms of concurrent blood-borne infections and characterisation of titre and seroneutralising activity of antibodies to EBOV (M8) Programme: H2020-EU.3.1. - Topic(s): Health |
Demonstrators, pilots, prototypes | 2019-07-24 |
Registration number of clinical trail acquired.Registration number of clinical studiy in a WHO- or ICMJE- approved registry. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Study protocol finalised, approved and implemented at study site.The final protocol will be jointly finalized by the consortium partners, and submitted for ethical and (when as applicable) regulatory clearance to the concerned ethical and regulatory bodies. The final consent forms will be prepared by adapting the ones of the UK ISARIC/WHO Clinical Characterisation Protocol and depending on the output of the anthropological pre-trial assessment to verify the potential to use multimedia (video, digital fingerprinting, other appropriate technology) to simplfy the process for staff and patients but ensure optimum informed consent. An complete outline and potential examples will be included in the ethical submission package. Streamlined, fast-track procedures will be sought. The consortium may count on the support of WHO for approaching national bodies. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Comprehensive community mobilization strategy initiatedThe community communication strategy and social mobilisation strategy on how to approach the general public, patients and families, donors and familes and the media, will be based on the pre-trial anthropological assessments and will be progressively implemented with regular evaluation and feedback to ensure optimum outputs. Programme: H2020-EU.3.1. - Topic(s): Health |
Demonstrators, pilots, prototypes | 2019-07-24 |
Comprehensive scientific, clinical, strategic and organisational managementComprehensive oversight to the project includes the convening of all project management structures: Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Monitoring of virological response to treatmentTo provide characterisation of the kinetics of viral load in treated patients (M12) Programme: H2020-EU.3.1. - Topic(s): Health |
Demonstrators, pilots, prototypes | 2019-07-24 |
Follow-up and management of press and media evaluatedThis epidemic is being played out on a daily basis on different and multiple media channels. Both internationally and nationally the media can be a source of mis-information as easily as it can be a source of correct information. For this reason and in regard to the high level of tension generated by this disease in affected populations, it will be essential to also make formal briefings to the press. All media channels should be included. The media task-force under the guidance of the TMG will be responsible for a comprehensive strategy to deal with this issue, including training and briefing of staff when and if necessary. This deliverable will evaluate how the media and press management strategy of the trial supported optimum trial delivery. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Contribution to international and national scientific platformsRefers to all and any contributions to scientific platforms (both national and international) that result from any elements of this trial, including after funding period is finished. Programme: H2020-EU.3.1. - Topic(s): Health |
Demonstrators, pilots, prototypes | 2019-07-24 |
Analysis of survival rate of patients with standardized supportive care (only).Analysis of the survival rate of the first cohort of 100 patients with clinical and scientific conclusions on the efficacy of SC for the treatment of EVD during an emergency in poor resource settings. Programme: H2020-EU.3.1. - Topic(s): Health |
Demonstrators, pilots, prototypes | 2019-07-24 |
Independent, all-inclusive Data safety management through either an Ebola centralised WHO umbrella group or ad hoc DSMBA Data Safety Monitoring Board (DSMB) must be in place. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Ethical approval from overseeing Ethical Committees and Review BoardsThe protocol will be submitted for ethical approval in the country of the sponsor (Belgium), at the Institutional Review Boards/Ethics Committee of other research partners where applicable, to other research partners (not in consortium but instrumental for the implementatio of the action) and to national ethics committees with identified or potential study sites (Guinea foreseen at the time of writing this Grant Agreement). The provisional list of concerned bodies is as follows: Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Results of trial posted on Study Registry including CWB, CP, SCAll results pretaining to this trial(including CWB, CP, SC) will be posted on the Study Registry. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Thorough ethical oversightEthic advisors, will constitute the Project Ethics Committee and ensure an all-inclusive overview of all ethical issues pertaining to this study. Ethics committee reports will be reported seperately at the due periodic reporting periods. The output of ethics committee meetings which constitute a change or difficulty within the study will be sent as ad hoc reports to the Commission. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Optimal standardized supportive care for EVD patients established.At present the only available option for EVD patients is supportive care. Under the present under-resourced conditions it is difficult to establish the impact of high quality standardized care on fatality rates. One of the aims of this study is to collect data on all patients admitted to the ETC both prior and after CBT is available. Patients admitted while CBT is not available; are ineligible for CBT; or who do not provide informed consent, will be provided with standardized supportive care and will serve as a \'control group\' for patients that recieve CWB or CP (or a possible contingency treatment, depending on the evolution of the epidemic and developments during the implementation of the trial. Programme: H2020-EU.3.1. - Topic(s): Health |
Demonstrators, pilots, prototypes | 2019-07-24 |
Contribution to national (study site) and international EVD health platforms evaluatedEvaluation of progressive input of trial team and supporting management structures (PCC, PAC, SSC, PEC, TMG) to national and international EVD platforms for the duration of the trial, including interlinkages with other research consortia and platforms. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |
Analysis of survival rate of CP on cohort of 100 patientsAnalysis of the survival rate of the first cohort of 100 patients with clinical and scientific conclusions on the efficacy of CP for the treatment of EVD during an emergency in poor resource settings. Programme: H2020-EU.3.1. - Topic(s): Health |
Demonstrators, pilots, prototypes | 2019-07-24 |
Reporting and/or analysis of contingency strategies and/or treatments resulting from unidentified, unforeseen or unavoidable issues which present during the trial period.Analysis of the survival rate of the a cohort of patients with clinical and scientific conclusions on the efficacy of CWB for the treatment of EVD during an emergency in poor resource settings. Programme: H2020-EU.3.1. - Topic(s): Health |
Documents, reports | 2019-07-24 |