Up to 30,000 health care workers from across the globe will be recruited to participate in a clinical trial co-led by University College London (UCL), which aims to establish whether chloroquine could be an effective prophylaxis against COVID-19.
The double-blind randomised placebo-controlled study brings together international physicians and scientists, to form the COVID-19 Research Outcomes Worldwide Network (CROWN) Collaborative. The 'CROWN CORONATION' study will recruit front-line health care workers globally, including those from lower and middle income countries.
The trial has been granted urgent public health status by the UK’s National Institute for Health Research (NIHR). In the UK, health care workers will be recruited from several hospitals, including those at UCL Hospitals NHS Foundation Trust.
Prof Laurence Lovat, UK lead investigator (UCL Surgery and Interventional Sciences) said: “Our hypothesis is that chloroquine may decrease the COVID-19 burden by decreasing entry of the novel coronavirus into host cells and by inhibiting viral replication."
“Furthermore, with its anti-inflammatory properties, chloroquine might dampen the exaggerated and unregulated immune response in the host, which often is responsible for the unpredictable and severe complications of COVID-19.”
Participants will be randomly assigned to one of the four groups: high-dose, mid-dose, low-dose chloroquine or placebo. If the accumulating data demonstrates that the treatment is effective, the placebo arm of the trial might be discontinued at an interim analysis.
Trial statistician, Dr Hakim-Moulay Dehbi (Comprehensive Clinical Trials Unit at UCL), said: “Healthcare workers need to be safe at work and this trial will tell us whether chloroquine could become part of their PPE tool box."
"We aim to find the lowest effective dose, as this would allow the limited global stocks of chloroquine to be spread more widely.”
The trial has been funded by the by the 'COVID-19 Therapeutics Accelerator', an initiative with contributions from an array of public and philanthropic donors.