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Advancing knowledge for the clinical and public health response to the 2019-nCoV epidemic

 

Proposals submitted under this expression of interest are expected to advance the knowledge on 2019-nCoV and its impact on infected persons, with the aim of contributing to an efficient patient management and/or public health preparedness and response. Proposals must be timely, with rapid activation, to enable early and valuable outcomes to be established. For increased impact, proposals may wish to build on promising avenues from previous or ongoing research.

Considering that this is a newly identified virus, the scope of this expression of interest remains broad and may include topics such as:

  • Development of therapeutics, including monoclonal antibodies. As relevant, evidence of regulatory and ethics approvals for the investigational products included in the study(ies) must be presented.
  • Development of point of care diagnostics, ensuring rapid evaluation of candidates based on existing technologies, to allow for fast case detection and surveillance.
  • Clinical and epidemiological studies, to provide data on epidemiological characteristics such as viral genotype and pathogenicity; clinical information on host susceptibility and host immune responses; risk factors for severe disease; routes of transmission and their relative importance; identification of the animal reservoir; etc.
  • Social sciences research, to provide urgently needed answers to social dynamics of the outbreak and the related public health response.

Proposals covering investigation of therapeutic and/or vaccines should consider engaging with the European Medical Agency (EMA) to ensure adequacy of the proposals from a regulatory point of view, i.e. via the innovation task force[[https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines#ema's-innovation-task-force-(itf)-section]] scientific advice or consultation in the context of the health threats interactions[[https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance/requesting-scientific-advice-protocol-assistance-ema]] [[https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats]].

Where relevant, proposals should consider the close collaboration with leading European supercomputing centres to use high-end computing, data and simulation resources in order to accelerate the processes of diagnosis and vaccine research and development. In this respect, the Supercomputing facilities in Barcelona (BSC) and Bologna (Cineca) are open to collaborate with any interested proposer or successful proposal. Other leading European supercomputer centres, such as the organisations hosting the PRACE Tier-0 supercomputers, may also be interested in such collaborations.

Applicants should be aware that proposals funded under this expression of interest will be required to make available their research data, in accordance with the relevant option of Article 29.3 of the H2020 model grant agreement. The use of harmonised protocols in collaboration with other actors is recommended for this purpose.

The Commission considers that proposals requesting a contribution from the EU of between EUR 2 and 3 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. Please note that expenditures can be covered from the date of submission of the proposal, but at the applicant’s own risk. Proposals can be concise and should focus on the essential information to facilitate an appropriate evaluation.

On 31 December 2019, the local authorities of Wuhan, Hubei province, China, reported a cluster of pneumonia cases of unknown origin. On 9 January 2020, the China Centre for Disease Control reported a novel Coronavirus (2019-nCoV) to be the causative agent.

As of 30 January 2020, 7824 laboratory-confirmed cases of 2019-nCoV have been reported including 170 deaths[[https://www.ecdc.europa.eu/en/novel-coronavirus-china]]. The disease has already spread to 19 countries outside China, with new cases continuing to emerge daily.

Recalling the SARS-CoV epidemic in 2003 with over 8000 cases reported (10% case fatality), it is crucial to rapidly gain a better understanding of the newly identified virus, especially in relation to potential clinical and public health measures that can be put to immediate use to improve patients’ health and/or contain the spread of 2019-nCoV.

  • To contribute to the diagnosis and clinical management of patients infected by 2019-nCoV.
  • To contribute to the public health preparedness and response in the context of the ongoing epidemic of 2019-nCoV.