From the outset, CHDR has been closely following the developments in the outbreak and spread of the coronavirus (COVID-19) and has been takingall necessary steps to limit the potential risks it could have on our volunteers, employees, and clients. In line with the Dutch National Centre for Disease Control (RIVM) and governmental guidelines, most of our employees have been working from home. Additionally, we decided to temporarily put a hold on ongoing studies where possible, and to suspend all planned studies in order to safeguard the well-being of our subjects and employees. However, this does not mean we have been quietly waiting for this pandemic to be over. Our extensive experience in conducting early phase clinical trials and vaccine research provides us with the tools and knowledge to do our part in the battle against COVID-19.
Collaboration with LUMC on Gilead’s remdesivir trial
Over the past few weeks, we have been collaborating with the Leiden University Medical Center (LUMC) on a multicenter Gilead trial with remdesivir. Preliminary, positive findings from initial trials with remdesivir have recently been announced by Gilead and can be found here. However, there is still more work to do and we will continue to support LUMC with this trial.
Fast track for Vaccine Research approach
Next to the Gilead trial, we have been working on/discussing other COVID-19 trials, both CHDR funded and industry sponsored. To enable rapid and efficient start-up times for these and future first-in-human vaccine trials, we have prepared a Fast Track for Vaccine Research approach, our so called beReady protocol. For this approach, we aimed to have a pool of dedicated healthy volunteers available to be enrolled and dosed within less than three weeks. For this purpose, we joined forces with the Dutch Health Authorities (CCMO) and several expert immunology laboratories and academic partners. Our beReady protocol includes a general clinical vaccine protocol and consent procedure that are approved by the CCMO. This enables us to maintain a pre-screened pool of healthy volunteers ready to enter a clinical vaccine study. The only information that has to be approved before the study can commence is vaccine specific documentation. The CCMO has agreed to review that documentation
(based upon a previously developed format) urgently in their dedicated mandate
group. Additionally, our expert partner laboratories have also assured rapid turnaround times for viral screens when needed. We are therefore more than ready to support companies in the conduct of their COVID-19 trial and we encourage you to contact us with any questions or requests to explore the beReady protocol together.
We once again wish you continued strength in your work and otherwise, and good health to you and your loved ones. We are convinced we will get through these challenging times together.
