Grifols, a pharmaceutical company based out of Barcelona, Spain, has announced that their potential treatment for the novel coronavirus has entered a phase 3 trial, according to BioSpace. It is being conducted in a collaboration with multiple U.S. federal agencies, such as the NIH. The intention of the trial is to evaluate safety, tolerability, and efficacy.
About the Trial
This trial will evaluate Grifols’ anti-SARS-CoV-2 hyperimmune globulin, which provides a consistent and high concentration of neutralizing antibodies. Creators of the medication believe that it could help to prevent and treat COVID-19. They believe that if it is given when symptoms are first noticed, it could change the body’s natural antibody response and lower the chance of a severe case and death.
The trial itself is multicenter, international, randomized, placebo-controlled, double-blind, and adaptive. 500 adults who are in hospitals across 18 countries will receive either the anti-SARS-CoV-2 hyperimmune globulin in combination with remdesivir or a placebo and remdesivir.
If this trial ends successfully, Grifols has stated that it is ready to produce large volumes of the treatment in a short amount of time. They are also working on 25 other initiatives to combat COVID-19, many of which use existing treatments to treat the virus. They are hopeful that not only will their Phase 3 study of anti-SARS-CoV-2 hyperimmune globulin end in success, but that their other trials do as well.