ABSTRACT
Objective The Covid Response Study (COVRES, NCT05548829) aims to carry out an integrated multi-omic analysis of factors contributing to host susceptibility to SARS-CoV-2 among a patient cohort of 1000 people from the geographically isolated island of Ireland. Background Health organisations and countries around the world have found it difficult to control the spread of the coronavirus disease 2019. To minimise the impact on the NHS and improve patient care, there is a drive for rapid tests capable of detecting individuals who are at high risk of contracting severe COVID-19. Early work focused on single omic approaches, highlighting a limited amount of information. Study Design The protocol below describes the study to be carried out in Northern Ireland (NI-COVRES) by Ulster University, the Republic of Ireland component will be described separately. All participants (n = 519) were recruited from the Western Health and Social Care Trust, Northern Ireland, forty patients are also being followed up at 1, 3, 6 and 12 months to assess the longitudinal impact of infection on symptoms, general health, and immune response, this is ongoing. Methods Data will be sourced from whole blood, saliva samples, and clinical data from the Northern Ireland Electronic Care Record, general health questionnaire, and the GHQ12 mental health survey. Saliva and blood samples were processed for DNA and RNA prior to whole genomic sequencing, RNA sequencing, DNA methylation, microbiome, 16S, and proteomic analysis. Multi-omics data will be combined with clinical data to produce sensitive and specific prognostic models of severity risk. Results An initial profile of the cohort has been completed: n = 249 hospitalised and n = 270 non-hospitalised patients were recruited, 64% were female, the mean age was 45 years. High levels of comorbidity were evident in the hospitalised cohort, with cardiovascular disease and metabolic and respiratory disorders (P < 0.001) being the most significant. Conclusion This study will provide a comprehensive opportunity to study multi-omic mechanisms of COVID-19 severity in re-contactable participants. Trial Registration - The trial has been registered as an observational study on clinicaltrials.gov as NCT05548829. An outline of the trial protocol is included; SPIRIT checklist (Supplementary Fig. 1).