On 30th January 2020, the Director General of the World Health Organisation (WHO) declared the outbreak of 2019-nCoV a public health emergency of international concern. In his statement, Dr Tedros Ghebreyesus called for solidarity and cooperation to accelerate preparations and to advance knowledge on the virus and its impacts.
The Platform foR European Preparedness Against (Re-) emerging Epidemics (PREPARE) has now mobilised to mode 2 response activity, representing an important next level of preparedness for the actual conduct of clinical research in the event of further 2019-nCoV spread in Europe. At present, 366 hospitals and 73 paediatric sites from PREPARE partner networks, COMBACTE and Penta, were mobilised to contribute to the important collective global efforts in standardising the information gathered from affected patients. They have the potential of acting as sites to respond to an immediate emerging infectious disease threat. An electronic case report form (eCRF), developed by ISARIC and WHO, has been distributed across these networks so that the same information can be gathered from patients with suspected or confirmed 2019-nCoV. “This is the first time that there is a harmonised European collaboration for data collection of patient data during an outbreak. It is a crucial step to enable sharing and comparing information to inform public health responses,’ explains Prof Herman Goossens, coordinator of PREPARE.
In addition, PREPARE and COMBACTE have distributed 270 surveys to diagnostic laboratories linked with their research networks in 42 European countries. The goal of the survey is to ensure their preparedness for detecting the 2019-nCoV in the event that a clinical trial is rapidly initiated. We are also making preparations for large-scale observational studies in many European countries on acute respiratory tract infections in patients consulting their general practitioners or admitted to hospitals. These studies will help establishing the prevalence, severity and disease spectrum, outcomes, and clinician and patient perspectives on the novel 2019 coronavirus epidemic in selected European countries.
Finally, PREPARE is continuing its global initiatives in the REMAP-CAP clinical study to evaluate different treatment options in patients with severe lung infections, including those caused by the 2019-nCoV. Together with its global partners, PREPARE is planning extension of the network to include more sites and countries.
PREPARE is closely monitoring the situation and will escalate to mode 3 when 2019-nCoV poses an immediate pandemic threat with sustained transmission in the European population. In mode 3 we will deliver clinical research to inform optimal treatment of patients infected with the 2019-nCoV and public health responses specific to this pandemic.
Herman Goossens, MD, PhD
Coordinator of the PREPARE Project
Laboratory of Medical Microbiology
B-2610 Antwerp – Belgium
+32 475 327344
PREPARE is funded by the European Union (2014 – 2021), to establish a European clinical research network covering primary care and hospital care in all EU Member States. Our response to severe outbreaks of infectious diseases is often delayed, isolated, and fragmented. PREPARE implemented large-scale clinical studies to build a European infrastructure for rapid clinical research responses in the face of new infectious disease threats. These clinical studies in inter-epidemic periods will train PREPARE in mounting a rapid, coordinated deployment of Europe’s clinical investigators. PREPARE is coordinated from the University of Antwerp in Belgium.
The COMBACTE projects were created to meet the challenges of clinical development of antibacterials in response to the worldwide growing problem of antibiotic resistance. In collaboration with other consortia within the IMI New Drugs 4 Bad Bugs (ND4BB) program, the projects will enable more rapid and efficient development and commercialization of much-needed new antibacterial treatments and diagnostic tests. The COMBACTE infrastructure, with more than 1,000 hospitals and close to 900 diagnostic laboratories in 42 European countries is used for clinical studies on the novel Coronavirus.
Penta is a global independent scientific network dedicated to research in child health. Starting out from its work in HIV, today Penta’s portfolio includes investigation into other infectious diseases affecting children, as well as infrastructure development initiatives and training programmes. Since 2012, Penta has sponsored 35 clinical trials, with more than 50,000 women and children enrolled into its studies. The work of Penta is supported by the Penta ID network, consisting of 110 clinical sites in 31 countries across the world whose expertise are leveraged to transform the prevention and treatment of infection in children.