Grifols starts the trial to test its immunoglobulin in patients with Covid-19.
Grifols has announced the start of the clinical trial in which the safety, tolerability and efficacy of hyperimmune immunoglobulin as a potential treatment for Covid-19 will be evaluated. According to the pharmaceutical company, this drug has a high and consistent concentration of antibodies that would neutralize the virus and could be applied both in the prevention and treatment of the disease. The study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH) in the United States.
The research seeks to determine whether the administration of anti-coronavirus hyperimmune immunoglobulin at the onset of symptoms can increase the patient’s antibody response to the virus, thus reducing the risk of severe disease and mortality. This is the first international and multicenter clinical trial of a hyperimmune immunoglobulin against Covid.
Anti-coronavirus hyperimmune immunoglobulin is being investigated in patients who present with respiratory symptoms and require hospitalization, but not admission to the intensive care unit. “We are hopeful with the advances in research on various potential treatments for the different phases of Covid-19, and we hope that they will soon be able to provide effective therapies for the disease,” said Víctor Grifols Deu, co-CEO of Grifols.
This phase 3 study is randomized, double-blind, placebo-controlled and adaptive, and will involve 500 adult patients hospitalized with Covid-19 from 58 hospitals in 18 countries, including the United States and Spain.
Grifols began developing the anti-SARS-CoV-2 immunoglobulin as part of a collaboration agreement with several US regulatory agencies, including the Biomedical Advanced Research Development Authority (BARDA), Food and Drug Administration (FDA) and NIH / NIAID, formalized in March this year. In addition to Grifols, Emergent BioSolutions, CSL Behring, and Takeda Pharmaceuticals are also providing products for this clinical trial.
In addition to this trial, Grifols is participating in more than 25 research projects on Covid-19. Among them, it has several clinical trials with plasma-derived treatments already available, such as alpha-1 antitrypsin, immunoglobulins, and Covid-19 convalescent plasma. These trials would be aimed at patients with mild symptoms, hospitalized patients and more severe cases requiring intensive care.