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The novel coronavirus, which first erupted at the end of 2019 in mainland China and is now spreading over more than 100 countries worldwide, is having a significant impact. The virus causes a respiratory disease called COVID-19 which passes rapidly from person to person and may be more severe than seasonal influenza. In Europe, a rapid response is crucial to limit its effect.
In 2014, the EU-funded PREPARE project set up a platform for European preparedness against emerging epidemics. It has been designed to ensure that clinical research is set in motion to study the many uncertainties created by a new disease, which has the potential to threaten the health and security of European citizens.
When faced with a new infectious disease like COVID-19, medical professionals and public health authorities confront many uncertainties. We need to know how it spreads, who is most at risk, how severe the disease is, and how patients are best diagnosed and treated, says Professor Peter Horby of the University of Oxford and a member of PREPAREs Outbreak Mode Committee (OMC).
Clinical research and trials are key to finding answers. However, this step often does not happen during the first stages of an outbreak, which means that researchers miss opportunities to improve the response to the new disease. PREPARE bridges this gap by being able to quickly put clinical research into action in a bid to save lives and advance medical knowledge.
PREPARE operates in four different modes: mode 0 occurs when there is no specific threat and research into generic preparedness activities can take place. Mode 1 prepare is activated when a specific disease presents a limited threat to Europe. Mode 2 mobilisation is deployed when there is a potential threat to Europe. Finally, Mode 3 response is reserved for an immediate threat.
When a specific disease emerges, such as that causing COVID-19, the projects OMC closely monitors the situation and coordinates the appropriate European response. The OMC comprises four leading professors in the field of emerging infectious diseases.
During Mode 0, when there is no epidemic, PREPARE carries out clinical research, including the MERMAIDS-ARI observational study with patients who have symptoms of acute respiratory infections, and the REMAP-CAP intervention study testing different treatment options in patients with severe lung infections.
The project has also evaluated the willingness of European citizens to take part in research and trials in the event of an epidemic or pandemic. This evaluation showed strong public support for pandemic-relevant clinical research initiatives.
Extensive clinical and laboratory work has been carried out to understand the development of severe disease in a large observational study of patients infected with common respiratory viruses, including the four known seasonal human coronaviruses. This provides a unique data repository and biobank for comparative immunology and pathogenesis studies for COVID-19, says Professor Menno de Jong of the University of Amsterdam and deputy project coordinator.
On 22 January, PREPARE entered mode 1 in response to the novel Coronavirus outbreak. During this phase, the project assessed Europes readiness by identifying knowledge and resource gaps and preparing clinical protocols. PREPAREs partners also developed initial protocols for detecting the virus and collaborated with other clinical research networks.
On 6 February 2020, PREPARE raised its response to mode 2. Under this mode, it sent surveys to 270 of its diagnostic laboratories, spanning 42 European countries, to assess their capacities to detect the virus. If the number of cases in Europe rises, a network of hospitals and primary-care sites across the EU are ready to carry out further research into COVID-19.
PREPAREs OMC has now moved to a Mode 3 response given that sustained transmission of the disease has been detected amongst the European population. If the current epidemic is not contained, and we need to prepare for a pandemic scenario, our networks are ready to do the necessary studies and trials. We will carry out these trials under RECOVER, a new project funded by the European Union as a response to the immediate threat of the novel coronavirus global outbreak, says Professor Herman Goossens of the University of Antwerp (Belgium), project coordinator of PREPARE and RECOVER.
PREPARE is connected to other global EU-funded clinical research networks including ALERRT and PANDORA in sub Saharan Africa, and ZikaPLAN, ZIKAlliance and ZIKAction in Latin America.