Cohort study of COVID-19 Nested within an RCT of Patients with Community Acquired Pneumonia: Disease severity, Management, and Outcomes

The COVID 19-CAPNOR study brings together a multidisciplinary research team that seeks to conduct research that will contribute to containing COVID-19, optimizing patient management and preparedness to the curre and analogous outbreaks. The Bergen CAPNOR consortium recently received funding from the Research Council of Norway (NORCAP 288718) and co-funding from the Trond Mohn foundation (RESPNOR 815276) to recruit patients hospitalized for community acquired pneumonia (CAP) at the Emergency Department (ED Haukeland University Hospital (HUS), Bergen, into a randomized controlled trial (RCT) to assess the impact of comprehensive ultra-rapid, molecular diagnostics compared to current standard of care on a broad range of clinical outcomes. CAPNOR, comprising a preparatory pilot study and the RCT (n=1390) has received approval from the Regional Ethics Committee (REK; 31935). A limited pilot study (n=100 CAP patients) was successfully completed in February 2020. COVID-19 cannot be distinguished clinically from other pneumonias. We propose to rapidly leverage our knowledge-and-skill base as well as, the established research infrastructure at the ED, HUS (e.g. trained study staff, standardised eCRFs, optimised sampling, molecular diagnostics, biobanking) to include patients with suspected COVID-19 at the start of the epidemic in Norway. The patient-centred, opportunity driven cohort study will contribute to i) understanding natural history, disease severity and susceptibility; ii) identify groups at high risk of serious infection; iii) optimising sampling strategies and triage processes; iv) optimizing patient management; v) optimising virus detection, elucidating compartments of replication and mapping of antibody responses; vi) supporting capacity building, infection prevention and control measures and best practice to protect health care workers.