NIH to study synthetic antibody therapy; FDA authorizes first serology tests to display estimated antibodies
The National Institutes of Health today announced clinical trials to investigate the safety and efficacy of a synthetic antibody therapy in COVID-19 patients. seeks to enroll about 300 volunteers who have been hospitalized with mild to moderate COVID-19; seeks to enroll 220 volunteers who report symptoms of COVID-19 and test positive for the virus but do not require hospitalization.
In other news, the Food and Drug Administration Friday two Siemens serology tests for COVID-19 that display an estimated quantity of antibodies present in the individual鈥檚 blood.
鈥淭here are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today鈥檚 authorizations give us additional tools to evaluate those antibodies as we continue to research and study this virus,鈥 said Tim Stenzel, M.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA鈥檚 Center for Devices and Radiological Health. 鈥淧atients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.鈥