Completion of FDA Project – Development of a Model that Integrates Inflammation and Tissue Injury to Predict and Mitigate the Post-Acute of COVID19 FDA-OC-25-130611

People infected with SARS-CoV-2 (the virus that causes COVID-19) typically recover within a few days or weeks. However some individuals have long-term effects that persist for multiple weeks, months, or even years; this is known as post-COVID conditions (PCC) or long COVID. In such cases, people experience both obvious and subtle long-term health consequences after recovering from the active infection. While PCC occurs more frequently in people who have had severe COVID-19 illness, individuals experiencing these health consequences are not limited those who were the sickest. These effects manifest in patients across the full spectrum of COVID-19 severity and ages, including children. At this time, it is not possible to identify patients who will develop PCC during the active phase of COVID-19 infection. If it were possible to identify patients who are more susceptible to suffering long-term health consequences of SARS-CoV-2 infection, then it may be possible to mitigate those outcomes with medical interventions. While considerable efforts have gone into understanding how COVID-19 affects the body in adults, much less is known about how COVID-19 affects children, and how those effects manifest into long-term health consequences of COVID-19 infection. Research to develop both pediatric and adult models of PCC/long COVID was original funded by FDA Office of the Chief Scientist/Office of Regulatory and Emerging Science (OCS/ORES) in 2022. However, due to an administrative error, the contract ended prior to work completion and final reporting/analysis. Given the success of the technical approach to date and the value of preliminary data, among other factors, FDA has determined the criticality to complete the project. As such, this contract will support completion of final deliverables by the performer.