How to carry out rapid clinical research in combating COVID-19

Amid ongoing efforts to tackle the coronavirus pandemic, some European countries have begun to take cautious steps to ease lockdown restrictions while others brace for worse. Like several ongoing EU-funded research projects that have reoriented their work to help combat the outbreak, the PREPARE project is responding to COVID-19 by rapidly assessing Europe's preparedness and deploying vital clinical research. Through its network of hospitals and primary care sites across the EU, the project uses a coordinated, coherent and united clinical research approach to cope with severe infectious disease outbreaks like COVID-19.

An article by the European Commission explains how the project "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." Quoted in the same article, Prof. Peter Horby from project partner the University of Oxford says: "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." Clinical research and trials are crucial to addressing these issues, but these generally miss the initial stages of an epidemic or pandemic, which means the opportunity to improve patient outcomes is missed. "PREPARE bridges this gap by being able to quickly put clinical research into action in a bid to save lives and advance medical knowledge," as noted in the same article.

Different response modes

PREPARE delivers clinical research 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 – 'mobilization' – is deployed when there is a potential threat to Europe. Finally, Mode 3 – 'response' is reserved for an immediate threat."

In January, PREPARE entered outbreak response mode 1. "During this phase, the project assessed Europe's readiness by identifying knowledge and resource gaps and preparing clinical protocols. PREPARE's partners also developed initial protocols for detecting the virus and collaborated with other clinical research networks." In February, PREPARE switched to response activity mode 2 and "sent surveys to 270 of its diagnostic laboratories, spanning 42 European countries, to assess their capacities to detect the virus," as stated in the same article. In March, PREPARE upgraded its response efforts to outbreak research response mode 3, "given that sustained transmission of the disease has been detected amongst the European population."

In the same article, Prof. Herman Goossens from project coordinator the University of Antwerp says that under a pandemic scenario, the project's "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." RECOVER (Rapid European SARS-CoV-2 Emergency research Response) "will inform future research response efforts to further strengthen Europe's and global clinical research preparedness to future emerging infectious diseases," according to a news item on the PREPARE project website. The PREPARE (Platform foR European Preparedness Against (Re-)emerging Epidemics) project will end in January 2021.