The new drug would provide immediate post-exposure protection against the virus and would be especially useful as a complement to the vaccine in the early phase after vaccination.
In addition, it could protect the elderly and healthcare workers as well as immunocompromised patients for whom vaccination isn't recommended.
It could also help contain outbreaks in places where the vaccination hasn't begun or is still underway.
Grifols expects this clinical trial, led by the researchers Oriol Mitjà and Bonaventura Clotet, from Germans Trias i Pujol Hospital in Barcelona, to begin in February 2021, with the possibility of results in the spring.
About 800 patients, all asymptomatic but having tested positive for the virus in a diagnostic test, will participate in the clinical study, receiving subcutaneously Grifols' immunoglobulin rich with anti-SARS-CoV-2 antibodies.
The Grifols immunoglobulin Gamunex-C, whether administered intravenously, intramuscularly or subcutaneously, has proven to be safe and efficacious in the prevention of diverse infectious diseases in immunocompromised patients and has been used for this for more than 15 years.
Grifols, a leader in the production and distribution of immunoglobulins and hyperimmune immunoglobulins, currently has underway more than 25 research initiatives to treat different stages of COVID-19, from early exposure to the virus to severe cases requiring hospitalization and intensive care.
In October 2020, Grifols, together with other companies and various US health agencies, began the clinical trial ITAC (Inpatient Treatment with Anti-Coronavirus Immunoglobulin) to evaluate the efficacy and safety of the anti-SARS-CoV-2 hyperimmune globulin in hospitalized and serious cases.
Results are expected during the first half of 2021.
Grifols is a global healthcare company that since its founding in Barcelona in 1909. Its four divisions Bioscience, Diagnostic, Hospital and Bio Supplies develop, produce and market solutions and services in more than 100 countries.
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