Doctors will run a rapid-fire clinical trial in Ebola treatment centres across West Africa, testing multiple experimental drugs against the virus in real time during an outbreak. The problem is that Ebola outbreaks move faster than traditional drug trials: by the time a standard placebo-controlled study finishes, the epidemic may already be over, leaving no clear answer on whether a treatment works. This platform is designed to sort candidate drugs into three categories as quickly as possible—very effective, promising, or ineffective—using a flexible, non-randomised design that compares patients to historical controls. If successful, the platform could transform how the world responds to future Ebola outbreaks, turning treatment centres into evidence-generating machines rather than simply places of care. The medium-term goal is to evaluate three classes of antiviral agents: neutralising antibodies like ZMapp, RNA inhibitors like TKM-100802, and other antivirals such as Brincidofovir. This is not fundamental science; it is a pragmatic, operational solution to a logistical and ethical problem—how to test drugs in a crisis without sacrificing scientific rigour or patient care.
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We aim to establish a clinical trials platform in two or more Ebola Virus Disease (EVD) treatment centres in West Africa through which the efficacy and safety of un-registered therapeutic products can be rapidly assessed in patients with EVD. Therapeutic options will be evaluated in a standardised format that is consistent with ethical standards and the delivery of patient care in challenging conditions, and will provide data for potential regulatory approval. Following a run-in' observational stage, the initial pragmatic intervention study design is an openlabel, non-randomised trial with sequential enrolment and analysis of subjects and with historic and contemporaneous controls. Multiple products will be assessed separately using a standardised methodology. The trial is designed to distinguish as rapidly as possible between three situations: (a) the treatment is very effective, (b) the treatment is promising and (c) the treatment is ineffective. The platform will be established and operationalized in the near term using two agents studied in series or parallel (depending on availability). The selection of the initial agent for evaluation will be decided within the next two weeks, as additional data become available. The medium term objective is to provide a platform for the evaluation of three therapeutic classes with different modes of antiviral action: neutralising antibodies (e.g. ZMapp, convalescent plasma); RNA inhibitor molecules (e.g. TKM-100802/AVI-7537); other antivirals (e.g. Brincidofovir).
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