A clinical trial to test the safety, tolerability and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, has begun. The study is taking place in hospitalized adults with COVID-19 in the United States, Mexico and 16 other countries on five continents. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the Phase 3 trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC.
The antibody solution being tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG. The antibodies in anti-coronavirus hIVIG come from the liquid portion of blood, or plasma, donated by healthy people who have recovered from COVID-19. These antibodies are highly purified and concentrated so that the anti-coronavirus hIVIG consistently contains several times more SARS-CoV-2 neutralizing antibodies than typically found in the plasma of people who have recovered from COVID-19.
The ITAC investigators hypothesize that giving people anti-coronavirus hIVIG at the onset of COVID-19 symptoms, before the body makes a protective immune response on its own, could augment the natural antibody response to SARS-CoV-2, thereby reducing the risk of more serious illness and death.
“Finding safe and effective treatments for COVID-19 is absolutely critical,” said NIAID Director Anthony S. Fauci, M.D. “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.”
Leading the ITAC trial is Protocol Chair Mark Polizzotto, M.D., Ph.D., head of the Therapeutic and Vaccine Research Program at The Kirby Institute in the University of New South Wales, Sydney. The University of Minnesota is the coordinating center for the trial, which is being conducted by the NIAID-funded International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). While INSIGHT was established to conduct clinical studies on HIV, it also has been involved in clinical trials related to influenza-like illness and the role of anti-influenza hIVIG since 2009. The ITAC trial also is known as INSIGHT 013.
Four companies are collaborating to provide anti-coronavirus hIVIG for the trial: Emergent BioSolutions of Gaithersburg, Maryland; Grifols S.A. of Barcelona; CSL Behring of King of Prussia, Pennsylvania; and Takeda Pharmaceuticals of Tokyo. The hIVIG from Emergent BioSolutions and Grifols S.A. was developed with support from the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. CSL Behring and Takeda Pharmaceuticals are providing anti-coronavirus hIVIG on behalf of a worldwide partnership of plasma companies called the CoVIg-19 Plasma Alliance. Read from source….