supplemental funding for the hrb-ctn in critical care to support their participation in an international clinical trial in response to covid-19 (remap-cap)

The purpose of a Clinical Trial Network (CTN) is to develop strong cross-institutional collaborations and partnerships between health practitioners and researchers in an area of health. A CTN provides the critical mass needed to conduct clinical trials in that area, supports coordination and enables that community to develop a strategy for clinical trials nationally. All patients who are treated in an Intensive Care Unit (ICU) for Community-Acquired Pneumonia (CAP) will receive therapy that consists of multiple different treatments, as many as 20 or 30. These therapies act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different therapies, most of which are known or believed to be safe and effective. However, doctors don't always know which treatment option is the better one, as individuals or groups of individuals may respond differently. REMAP-CAP, a platform trial, uses an innovative trial design to efficiently evaluate multiple interventions for CAP simultaneously and aims to help doctors understand which treatments work best. REMAP-CAP was one of a number of trials funded by the European Commission under FP7, as a Work Package in the PREPARE project. The aim of funding PREPARE (and embedded trials) was to build a European infrastructure for rapid clinical research responses in the face of new infectious disease threats . In response to COVID-19, the HRB CTN in Critical Care and participating partners of REMAP-CAP have activated the Pandemic Appendix to the Core Protocol so that the platform can respond rapidly in the event of widespread disease resulting from the novel 2019 coronavirus (COVID-19). The design of REMAP-CAP means that there is an overall protocol that governs individual domains (i.e. steroids, antibiotics etc.) and pandemic/winter domains (i.e. oseltamivir). Two separate COVID-19 domains (one anti-viral and one immunomodulatory) have been added in response to recent events. Changes to the protocol are aligned with recent WHO pandemic committee discussions, as two of the REMAP-CAP investigators are involved as members of the WHO pandemic core outcomes group.