PREDCOV - Blood test to predict the severity of COVID-19

COVID-19 er en uforutsigbar sykdom. Pr mai 2020 måtte rundt ~ 4% av de smittede legges inn på sykehus. Av dem trengte ~ 19% intensiv behandling og ~18% døde. Vaksiner, bedre behandling og omikronvarianten har bidratt til at prognosen ved COVID-19 har bedret seg betydelig, men det fortsatt utfordrende å vite på forhånd hvem som kommer til å få alvorlig sykdom. I dette prosjektet har vi oppdaget et epigenetisk mønster som kan skille pasienter med alvorlig COVID-19 sykdom fra de som har et mildt forløp, med høy grad av nøyaktighet. Vi har undersøkt at mønsteret korrelerer godt med alvorlighetsgraden av sykdommen, i mer enn tusen pasienter fordelt over USA, EU og Norge. Vi har videreutviklet funnet vårt i form av en prototype der vi har vist at mønsteret enkelt kan måles på laboratorieutstyr man finner i vanlige sykehuslaboratorier. Vi jobber nå med kommersielle samarbeidspartnere for å sette opp en fullskala test i et klinisk laboratorium. Prosjektet har vært et samarbeid mellom det nystartede diagnostikkselskapet Age Labs, Folkehelseinstituttet, Oslo Universitetssykehus og Bærum sykehus.

In this project, we successfully developed a highly accurate blood test that is able to separate patients with severe COVID-19 from those with a mild disease. The test is now in the process of being set up and validated in a clinical lab, with the aim of obtaining CE-IVD approval. After validation and regulatory approval, the test will become available for wider clinical use. In the project, we have also built a rich biobank, enabling us to investigate the potential of the underlying biological signal we identified for population screening purposes.

COVID-19 disease shows an unpredictable disease course with a wide range of complications. As of May 2020 the disease had a ~4% hospitalization rate. Of those hospitalized, ~19% required intensive care and ~18% died. Sepsis is another infectious disease that is often overlooked due to an unpredictable disease course. In Norway, this condition has an in-hospital mortality of ~24% and early diagnosis and treatment is essential. The PREDCOV project aims to address a clinical need related to this unpredictability: to better identify patients with COVID-19 and other infectious diseases at high risk for severe disease, complications and death, using a predictive blood test. The test will guide clinical decision making, improve patient outcome and reduce costs. It is well-documented that the gene expression in immune system cells follows a certain temporal pattern when faced with different bacteria, influenza virus, rhinovirus and coronaviruses, and that expression of specific genes correlates well with the severity of disease. We will collect and analyze genome-wide data on the gene-regulation of white blood cells to predict the outcome of COVID-19 and other severe infectious diseases. The data will be collected from patients before, during, and after their infection. Our project is uniquely positioned to perform the research quickly. Age Labs and the Norwegian Institute of Public Health have built and published blood-based prediction models from such data previously. The Dahl group at the Oslo University Hospital and Age Labs have collaborated to establish a prospective cohort study for COVID-19 patients in Norway, and we are already collecting the necessary blood samples. The Dept of Acute Medicine at Oslo University Hospital and Internal Medicine at Bærum Hospital treat patients with infectious diseases, including COVID-19 and sepsis. Both sites will run a trial study to evaluate the performance of the test in a representative hospital setting.