Emergency Evaluation of Treatments for Ebola Virus Disease. RAPIDE (360G-Wellcome-106491_Z_14_Z)

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).