Although there are a number of potential vaccines and therapies being looked at as possibly being effective against the Ebola virus, none have been adequately tested for both safety and effectiveness. Some interventions – like ZMapp, and blood transfusions from recovered patients – have been tried, but the extent to which they worked isn’t clear.
Figuring out how to use utilize these treatments in the midst of a raging epidemic – and still come away with data that can tell us if they are safe and effective – is a complex and time consuming task.
Today the World Health Organization has published a summary of a meeting held earlier this week by their Scientific and Technical Advisory committee on Experimental Ebola Interventions.
While there is a paucity of data thus far, follow the link below to see a summary of where things stand with the testing of Blood products (Convalescent whole blood (CWB) and convalescent plasma (CP)), immunoglobulin (IG) from survivors, and pharmaceuticals.
Date: 13 November 2014
Place: Geneva, Switzerland
Following the emergence of Ebola virus disease (EVD) as a severe public health emergency for which no effective therapeutic or prophylactic interventions are available, the scientific community has proposed numerous experimental interventions, including: vaccines; convalescent blood and plasma; and medicines. None of these interventions have been evaluated for efficacy against EVD and therefore clinical studies to assess their safety and efficacy are required.
To facilitate and accelerate the appropriate clinical testing and generation of quality data of potential therapeutic interventions for EVD, WHO convened a meeting of the Scientific and Technical Advisory Committee for Ebola Experimental Interventions (STAC-EE) in Geneva, on 11-12 November 2014. The meeting was attended by experts in Ebola virus, preclinical and clinical testing, pharmacologists, sociologists, public health experts and regulators, as well as representatives from countries in West Africa.
STAC-EE reviewed the data on disease progression and the effect of some experimental products on 18 patients who were evacuated from West Africa to well-resourced facilities in other countries. Resulting data did not permit evaluation of efficacy of these interventions, and the comparatively high survival rate observed in these patients may be due to a variety of factors including the high standard of care they received.
Noting that the standard of care in Ebola affected countries varies between different treatment centres and even in the same centres over time while standard of care is being established, it was agreed that clinical trials should only be conducted in facilities able to provide consistently good standard of care. The number of such sites in West Africa, capable of providing such care and with suitable infrastructure to conduct clinical trials, is limited. Indeed, there have been far more proposals of products to be tested than availability of sites in which they could be tested. It was therefore imperative that STAC-EE prioritize the products for testing, mindful of time pressure and to avoid wastage of resources.
Collecting clinical data under the biosafety conditions required when treating Ebola necessitates careful consideration of the minimum data that should be collected, and since trials may be across multiple sites ideally such data collection forms should be harmonised. One minimal clinical data collection form was presented which will be used by several of the groups planning clinical trials. Other groups indicated a preference to develop a shorter and simpler form, but which would use several of the same data fields. These forms should be able to permit data pooling at a future date.
In addition, the STAC-EE highlighted the need for rapid Point-of-Care diagnostics to reduce the time gap between sample taking and results being received from laboratories.