NIH clinical trial testing hyperimmune I.V. immunoglobulin plus remdesivir to treat COVID-19 begins

The National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring and funding a Phase III clinical trial testing the safety, tolerability, and efficacy of a combination treatment regimen for COVID-19 that includes remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2. The Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) trial will involve hospitalized adults with COVID-19 in the United States, Mexico, and 16 other nations across five continents. The antibody solution being tested in the trial is anti-coronavirus hyperimmune I.V. immunoglobulin (hIVIG). The antibodies in hIVIG are derived from plasma donated by healthy people who have recovered from COVID-19. The antibodies are highly purified and concentrated, so the anti-coronavirus hIVIG contains several times more SARS-CoV-2 neutralizing antibodies than usual for the plasma of individuals recovered from COVID-19 infection. According to NIAID Director Anthony S. Fauci, MD, “The ITAC trial will examine whether adding anti-coronavirus hIVIG to a remdesivir regimen can give the immune system a needed boost to suppress SARS-CoV-2 early in the course of illness, nipping the infection in the bud.”