Rapid Outcomes of COVid therapeutics in Eave II (ROCOVE)

This study is investigating the uptake, safety, and effectiveness of mAb therapy for COVID-19. In January 2022, the UK is experiencing a new wave of COVID-19 infections with the Omicron variant, at the same time as high circulating levels of Delta. There is evidence that the Omicron variant is more transmissible and concerns that existing interventions (e.g., COVID-19 Vaccines) may be less effective and some monoclonal antibodies (mAbs) may become ineffective due to mutations. Novel mAbs are limited resources and need to be targeted to those at highest risk of poor COVID-19 outcomes who are most likely to benefit. Interim guidance has been produced for use of novel mAbs and there is an urgent need to determine those likely to be eligible for these treatments to inform planning/ordering. It is also necessary to determine uptake to ensure they are being used in line with guidance. Rapid real-world evidence is also needed of the likely effectiveness of treatments alone and in combination to identify those patients who remain at risk despite treatments. This research will address a number of key questions, using existing research-ready datasets. We will use a data platform containing pseudonymised, linked data from vaccination records, virological testing and sequencing, clinical, and mortality records with coverage for the whole Scottish population. All data and analyses will be hosted within Public Health Scotland (PHS) and in due course in the Scottish national Trusted Research Environment.