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

COVID-19 is an unpredictable disease. As of May 2020, about ~4% of the infected had to be hospitalized. Of those, ~19% required intensive care and ~18% died. Vaccines, better treatment and the omicron variant have contributed to the prognosis of COVID-19 having improved significantly, but knowing in advance who will suffer from serious illness remains a challenge. In this project, we have discovered an epigenetic pattern that can distinguish patients with severe COVID-19 disease from those who have a mild course, with a high degree of accuracy. We have investigated that the pattern correlates well with the severity of the disease, in more than a thousand patients spread across the USA, the EU and Norway. We have further developed our find in the form of a prototype where we have shown that the pattern can easily be measured on laboratory equipment found in ordinary hospital laboratories. We are now working with commercial partners to set up a full-scale test in a clinical laboratory. The project has been a collaboration between the newly started diagnostics company Age Labs, the National Institute of Public Health, Oslo University Hospital and Bærum Hospital.

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.