Contract Pharma Staff01.18.21
Grifols, a developer of therapies with plasma-derived proteins, will begin a clinical trial in Spain to evaluate the safety and efficacy of a new COVID-19 drug based on the Grifols immunoglobulin Gamunex-C and containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease.
The new drug would provide immediate post-exposure protection against the virus and would be 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 the trial 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 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.
The new drug would provide immediate post-exposure protection against the virus and would be 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 the trial 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 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.
