Antwerp, Belgium – 24 February 2020
Confirmed SARS-CoV-2 infected patients have been reported in Europe for several weeks now and PREPARE has been monitoring developments very closely. In Italy, cases of the novel coronavirus, SARS-CoV-2, have risen significantly over the weekend. Italian public health authorities have pressed ahead with measures to contain the spread of infection, including quarantining several towns in Italy’s northern region and suspending major public events. With ongoing clusters in Iran, South Korea, Singapore, Thailand, Vietnam, Hong Kong, Japan and more recently in Italy, we anticipate further large clusters and possibly community-wide transmission in Europe and therefore are preparing our clinical research response accordingly.
Based on these recent developments, PREPARE will continue its preparations for launching a clinical research response in Europe should this be needed. On 6 February PREPARE announced its mobilisation of the Mode 2 response activity for the actual conduct of clinical research in the event of further SARS-CoV-2 spread in Europe.
At present, 366 hospitals and 73 paediatric sites from PREPARE partner networks, COMBACTE and Penta, are contributing to the important collective efforts in standardising the information gathered from affected patients. 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 SARS-CoV-2. We are making active preparations across our primary care and hospital networks to deliver clinical research activities, for example, through ensuring contracts and ethical approvals are in place. PREPARE and COMBACTE continue to make sure that diagnostic laboratories linked with their research networks in 42 European countries are prepared for diagnosing patients with SARS-CoV-2 in the event that a clinical study is rapidly initiated. Further diagnostic preparedness activities are also underway. All activities are aligned with those of national public health agencies, ECDC and WHO regional offices.
“It is more and more likely that the SARS-CoV-2 outbreak will become a pandemic and PREPARE will rapidly raise the response level to Mode 3 if sustained transmission of SARS-CoV-2 is observed in several European countries. We are continuing a coordinated, coherent and united clinical research response,” says Herman Goossens, Professor at the University of Antwerp and Coordinator of PREPARE.
Contact person:
Herman Goossens, MD, PhD
Coordinator of the PREPARE Project
Laboratory of Medical Microbiology
Universiteitsplein 1
B-2610 Antwerp - Belgium
Herman.Goossens@uza.be
+32 475 327344
About PREPARE
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.
About COMBACTE
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 will be used for clinical studies on the novel Coronavirus.
About Penta
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. The Penta network will be used for clinical studies on the novel Coronavirus.