Risultati finali Documents, reports (13) Results of trial posted on Study Registry including CWB, CP, SC All results pretaining to this trial(including CWB, CP, SC) will be posted on the Study Registry. Thorough ethical oversight Ethic 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. Follow-up and management of press and media evaluated This 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. Ethical approval from overseeing Ethical Committees and Review Boards The 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: • WHO Ethical Research Committee (ERC) ; • Institutional Review Board (IRB) of the ITM, Antwerp, Belgium; • Ethics Committee of Antwerp University Hospital, Belgium (accredited by Belgian authorities); • Ethical Review Board of MSF; • Interventions Research Ethics Committee of LSHTM;In Guinea, a special research ethics committee dedicated to Ebola has been organized recently at national level; the WHO participates and is playing an active role. • Sierra Leone is a member country of AVAREF, a WHO/AFRO-led collaboration of National Ethics Committees and National Regulatory Authorities , started for of vaccines’ development /. This is not a joint decision making body, but it brings the relevant experts from the 23 countries together, plus external expert facilitators if needed, to discuss the applications in a peer group. Through AVAREF, WHO plans to support all the EDV-affected countries by convening joint reviews of applications. all the ethical approvals will be provided to the Commission as soon as they are obtained. Pre-trial anthropological assessments completed The 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. Contribution to national (study site) and international EVD health platforms evaluated Evaluation 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. 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. 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. This deliverable refers to the need to employ contingency plans as described in Part B, DOA of this Grant Agreement. The Commission will be informed of all and any changes in the study protocol and will recieve the associated ethical review documents in real time. Comprehensive scientific, clinical, strategic and organisational management Comprehensive oversight to the project includes the convening of all project management structures: - Project Coordination Committee - Project Advisory Committee - Project Ethics Committee - Scientific Steering Committee - Trail Management Group This process will be led by ITM but all beneficaries will be involved and certain support mechanisms (such as the PAC and SSC) will have independent, non-beneficary actors, including the represenation of national interests from the study site (Ministry of Health, Red Cross, etc.) The mechanisms of and interaction between these platforms will be well described and agree upon within any additional agreements pertaining to this study (Consortium agreement, trail agreements, Ministerial agreements, etc.) All elements pertaining to the comprehensive management of the study will be fully reported on in periodic technical reports pertaining to Grant Agreement regulations. Any issues arising outside of the reporting period will be covered in ad hoc reporting to the Commission. All minutes of meetings of committees will be kept for inspection or submission by or to the Commission, as required. Scientific publications Refers to all and any scientific publications that result from any elements of this trial, including after funding period is finished. Comprehensive community mobilization strategy evaluated While 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. Independent, all-inclusive Data safety management through either an Ebola centralised WHO umbrella group or ad hoc DSMB A Data Safety Monitoring Board (DSMB) must be in place. It woudl be preferably for all the EVD studies shoto be overseen by one single DSMB. Discussions are on-going at the time of writing this grant agreement to set-up such a central DSMB under the WHO umbrella. In the meantime, until established an ad hoc DSMB will be put in place, for independent ongoing monitoring of the efficacy and safety of the trial intervention. The minutes of the open-door meetings will be shared with the PCC. DSMB reports will be submitted as a seperate chapter of the period technical report. Any changes in the trial during the study period, resulting from DSMB deliberations, will be the subject of an ad hoc report to the Commission. Registration number of clinical trail acquired. Registration number of clinical studiy in a WHO- or ICMJE- approved registry. Demonstrators, pilots, prototypes (8) Contribution to international and national scientific platforms Refers 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. 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. Qualification of donated blood To 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) Monitoring of virological response to treatment To provide characterisation of the kinetics of viral load in treated patients (M12) 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. Analysis of survival rate of CWB on cohort of 100 patients Analysis 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. Analysis of survival rate of CP on cohort of 100 patients Analysis 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. Comprehensive community mobilization strategy initiated The 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. Pubblicazioni Peer reviewed articles (13) Blood as medicine: social meanings of blood and the success of Ebola trials Autori: Melanie Bannister-Tyrrell, Charlotte Gryseels, Alexandre Delamou, Umberto D'Alessandro, Johan van Griensven, Koen Peeters Grietens Pubblicato in: The Lancet, Numero 385/9966, 2015, Pagina/e 420, ISSN 0140-6736 Editore: The Lancet Publishing Group DOI: 10.1016/S0140-6736(14)62392-8 Organizing the Donation of Convalescent Plasma for a Therapeutic Clinical Trial on Ebola Virus Disease: The Experience in Guinea Autori: A. Delamou, N. Y. Haba, A. Mari-Saez, P. Gallian, M. Ronse, J. Jacobs, B. S. Camara, K. J.-J. O. Kadio, A. Guemou, J. P. Kolie, M. D. Crop, P. Chavarin, C. Jacquot, C. Lazaygues, A. D. Weggheleire, L. Lynen, J. van Griensven Pubblicato in: American Journal of Tropical Medicine and Hygiene, Numero 95/3, 2016, Pagina/e 647-653, ISSN 0002-9637 Editore: American Society of Tropical Medicine and Hygiene DOI: 10.4269/ajtmh.15-0890 Multiple ethical review in North-South collaborative research: the experience of the Ebola-Tx trial in Guinea Autori: De Crop M, Delamou A, van Griensven J, Ravinetto R Pubblicato in: Indian J Med Ethics, Numero 1(2), 2016, Pagina/e 76-82, ISSN 0974-8466 Editore: Forum For Medical Ethics Society Ebola: better protection needed for Guinean health-care workers Autori: Alexandre Delamou, Abdoul Habib Beavogui, Mandy Kader Kondé, Johan van Griensven, Vincent De Brouwere Pubblicato in: The Lancet, Numero 385/9967, 2015, Pagina/e 503-504, ISSN 0140-6736 Editore: The Lancet Publishing Group DOI: 10.1016/S0140-6736(15)60193-3 Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea Autori: Johan van Griensven, Tansy Edwards, Xavier de Lamballerie, Malcolm G. Semple, Pierre Gallian, Sylvain Baize, Peter W. Horby, Hervé Raoul, N’Faly Magassouba, Annick Antierens, Carolyn Lomas, Ousmane Faye, Amadou A. Sall, Katrien Fransen, Jozefien Buyze, Raffaella Ravinetto, Pierre Tiberghien, Yves Claeys, Maaike De Crop, Lutgarde Lynen, Elhadj Ibrahima Bah, Peter G. Smith, Alexandre Delamou, Anj Pubblicato in: New England Journal of Medicine, Numero 374/1, 2016, Pagina/e 33-42, ISSN 0028-4793 Editore: Massachusetts Medical Society DOI: 10.1056/NEJMoa1511812 Convalescent Plasma for Ebola Virus Disease Autori: van Griensven J, Edwards T, Gallian P; Ebola-Tx Consortium Pubblicato in: New England Journal of Medicine, Numero 374/25, 2016, Pagina/e 2498-2500, ISSN 0028-4793 Editore: Massachusetts Medical Society DOI: 10.1056/NEJMc1602284 Design and analysis considerations in the Ebola_Tx trial evaluating convalescent plasma in the treatment of Ebola virus disease in Guinea during the 2014-2015 outbreak Autori: T. Edwards, M. G. Semple, A. De Weggheleire, Y. Claeys, M. De Crop, J. Menten, R. Ravinetto, S. Temmerman, L. Lynen, E. I. Bah, P. G. Smith, J. van Griensven Pubblicato in: Clinical Trials, Numero 13/1, 2016, Pagina/e 13-21, ISSN 1740-7745 Editore: SAGE Publications DOI: 10.1177/1740774515621056 The Use of Ebola Convalescent Plasma to Treat Ebola Virus Disease in Resource-Constrained Settings: A Perspective From the Field Autori: Johan van Griensven, Anja De Weiggheleire, Alexandre Delamou, Peter G. Smith, Tansy Edwards, Philippe Vandekerckhove, Elhadj Ibrahima Bah, Robert Colebunders, Isola Herve, Catherine Lazaygues, Nyankoye Haba, Lutgarde Lynen Pubblicato in: Clinical Infectious Diseases, Numero 62/1, 2015, Pagina/e 69-74, ISSN 1058-4838 Editore: University of Chicago Press DOI: 10.1093/cid/civ680 Essentials of filoviral load quantification Autori: Lieselotte Cnops, Johan van Griensven, Anna N Honko, Daniel G Bausch, Armand Sprecher, Charles E Hill, Robert Colebunders, Joshua C Johnson, Anthony Griffiths, Gustavo F Palacios, Colleen S Kraft, Gary Kobinger, Angela Hewlett, David A Norwood, Pardis Sabeti, Peter B Jahrling, Pierre Formenty, Jens H Kuhn, Kevin K Ariën Pubblicato in: The Lancet Infectious Diseases, Numero 16/7, 2016, Pagina/e e134-e138, ISSN 1473-3099 Editore: The Lancet Publishing Group DOI: 10.1016/S1473-3099(16)30063-9 Drug assessment in the Ebola virus disease epidemic in west Africa Autori: Yazdan Yazdanpanah, Peter Horby, Johan van Griensven, France Mentre, Vinh-Kim Nguyen, Jean Marie Denis Malvy, Jake Dunning, Daouda Sissoko, Jean-Francois Delfraissy, Yves Levy Pubblicato in: The Lancet Infectious Diseases, Numero 15/11, 2015, Pagina/e 1258, ISSN 1473-3099 Editore: The Lancet Publishing Group DOI: 10.1016/S1473-3099(15)00344-8 Ebola: Europe–Africa research collaborations Autori: Peter William Horby, Hubert Endtz, Jean-Jacques Muyembe-Tamfum, Johan van Griensven, Sahr Gevao, Herman Goossens, Denis Malvy, Niankoye Yves Haba, Yazdan Yazdanpanah, Piero Olliaro, Malcolm G Semple, Menno de Jong, Alexandre Delamou, Trudie Lang, Gail Carson, Stephen B Kennedy Pubblicato in: The Lancet Infectious Diseases, Numero 15/11, 2015, Pagina/e 1258-1259, ISSN 1473-3099 Editore: The Lancet Publishing Group DOI: 10.1016/S1473-3099(15)00375-8 Electrolyte and Metabolic Disturbances in Ebola Patients during a Clinical Trial, Guinea, 2015 Autori: Johan van Griensven, Elhadj Ibrahima Bah, Nyankoye Haba, Alexandre Delamou, Bienvenu Salim Camara, Kadio Jean-Jacques Olivier, Hilde De Clerck, Helena Nordenstedt, Malcolm G. Semple, Michel Van Herp, Jozefien Buyze, Maaike De Crop, Steven Van Den Broucke, Lutgarde Lynen, Anja De Weggheleire Pubblicato in: Emerging Infectious Diseases, Numero 22/12, 2016, ISSN 1080-6040 Editore: US National Center for Infectious Diseases DOI: 10.3201/eid2212.161136 Efficacy of Convalescent Plasma in Relation to Dose of Ebola Virus Antibodies Autori: Johan van Griensven, Tansy Edwards, Sylvain Baize Pubblicato in: New England Journal of Medicine, Numero 375/23, 2016, Pagina/e 2307-2309, ISSN 0028-4793 Editore: Massachusetts Medical Society DOI: 10.1056/NEJMc1609116 È in corso la ricerca di dati su OpenAIRE... Si è verificato un errore durante la ricerca dei dati su OpenAIRE Nessun risultato disponibile
