The U.S. Food and Drug Administration (FDA) awarded a new research contract to Stanford University School of Medicine to perform an in-depth analysis of tissue samples to learn more about how SARS-CoV-2 — the virus that causes COVID-19 — affects different systems in the body, and identify immune correlates, according to a press release from the agency.
This regulatory science project could potentially help inform development and evaluation of medical countermeasures for COVID-19, the FDA said.
In this Medical Countermeasures Initiative (MCMi) regulatory science project, Stanford University School of Medicine will conduct research to help explain the host factors contributing to coronavirus immune responses, to further the ability to more rapidly predict patient outcomes, and to address unmet needs in patient care.
Researchers will use analytical tools to perform an in-depth analysis of existing tissue samples from previously conducted clinical and nonclinical studies. They will profile circulating immune signatures of coronavirus infection and complete COVID-19 pathology tissue imaging, leveraging tools to define the characteristics of tissue viral reservoirs (cell types or areas of the body where the virus persists), and learning more about how SARS-CoV-2 affects different systems in the body.
The project will identify immune correlates of protection, which could potentially help identify and inform development of new coronavirus MCMs, such as drug and vaccine candidates. The project will also help enhance understanding and use of immune correlates for the regulatory review of MCMs.
