October 9, 2020 -- Grifols has started its anti-SARS-CoV-2 hyperimmune globulin clinical trial, named Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC). The hyperimmune globulin provides a high and consistent concentration of purified neutralizing antibodies that could be used for both prevention and treatment of COVID-19.
The 500-person study aims to determine if giving the anti-coronavirus hyperimmune globulin when COVID-19 symptoms first appear could supplement the natural antibody response to SARS-CoV-2. The international, multicenter trial is randomized, double-blind, placebo-controlled, and adaptive. Study participants will receive the anti-SARS-CoV-2 hyperimmune globulin and remdesivir, or remdesivir plus placebo.
Grifols has collected convalescent plasma from healthy, recovered COVID-19 donors in the U.S. using its plasma-center network as well as in Spain through a collaboration with blood banks.
ITAC is sponsored and funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). Emergent BioSolutions, CSL Behring, and Takeda Pharmaceuticals are also providing products for the clinical trial.
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