Informal consultation on prioritization of candidate therapeutic agents for use in novel coronavirus 2019 infection
Overview
Currently there are no therapeutic agents licensed and available for novel coronavirus 2019. At the time of the deliberations, one clinical trial was currently ongoing in China including with Lopinavir and Ritonavir. Another RCT is being planned to evaluate the safety and efficacy of Remdesevir. Chinese experts are considering a flexible design that could include additional study arms if pertinent.
In order to rapidly inform the further design and conduct of clinical trials in regions affected by nCoV, there is an urgent need to progress with the prioritisation of the investigational candidates most suitable for clinical trials. A preliminary review of the current pipeline of candidates for treatment of the nCoV, at different stages of development, was conducted based on available information provided. There are major gaps in knowledge around the new virus, in particular the extent of its susceptibility to the different therapeutic options considered, as none of these were developed specifically for nCoV. Nevertheless, it is important that a high level prioritization is made based on the limited information available and updated as further pertinent data emerges.
During the Ebola Public Health Emergency of 2014-2016 WHO further developed its ethical guidance on use of investigational/repurposed therapeutics during outbreaks. This guidance placed a major emphasis on prompt initiation of well designed, ethical clinical trials using the most promising therapeutic candidates available. In the context of the current outbreak of nCov, individual patients may be offered investigational therapeutics on an emergency basis outside clinical trials, as part of protocols for compassionate use or as part of randomized clinical trial. WHO’s guidance “Managing Ethical Issues in Infectious Disease Outbreaks” states that compassionate use of unlicensed therapeutics, or Monitored Emergency Use of Unregistered Interventions, is only justified when clinical trials cannot be initiated immediately and where a set of defined ethical criteria are met (MEURI, https://www.who.int/emergencies/ebola/MEURIEbola.pdf).