Barcelona, Spain - Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people's health and well-being, today announced that its anti-SARS-CoV-2 hyperimmune globulin, a potential treatment for COVID-19, has started a randomized controlled clinical trial to test its safety, efficacy and tolerability. This medicine provides a high and consistent concentration of purified neutralizing antibodies and could be used for both prevention and treatment of the disease. The study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).
The start of the clinical trial is the latest phase of an initiative that goes back to March when Grifols started work on its anti-SARS-CoV-2 hyperimmune globulin as part of a collaboration with U.S. government agencies such as the Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA), the NIAID and the NIH. In addition to Grifols, the other manufacturers providing product for the trial are Emergent BioSolutions, CSL Behring and Takeda Pharmaceuticals.
Investigators running the clinical trial want to determine if giving the anti-coronavirus hyperimmune globulin when COVID-19 symptoms first appear, before a person's immune system makes a protective immune response on its own, could augment the natural antibody response to SARS-CoV-2, thereby reducing the risk of more serious illness and death.
This is the first international multicenter clinical trial of an anti-SARS-CoV-2 hyperimmune globulin, which is randomized double-blind, placebo-controlled and adaptive. Patients will receive either the anti-SARS-CoV-2 hyperimmune globulin and remdesivir, or remdesivir plus placebo.
The Phase 3 trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC), will include 500 hospitalized adults with COVID-19 in up to 58 hospitals covering 18 countries including the United States and Spain. For the trial Grifols has collected convalescent plasma from healthy recovered COVID-19 donors, in the U.S. using its plasma-center network and in Spain through a collaboration with blood banks.
Grifols has moved quickly to respond to the need for an anti-SARS-CoV-2 hyperimmune globulin. It was the first to mobilize large-scale collection of convalescent plasma, using its industry-leading network of more than 300 plasma-collection centers. It was also the first to manufacture and deliver clinical batches of the anti-SARS-CoV-2 hyperimmune globulin. The company's primed infrastructure is ready to ramp up quickly to produce large volumes of medicine should they be needed.
Grifols is proud to lead or participate in more than 25 initiatives to fight COVID-19. This includes several clinical trials with already existing plasma-derived therapies, such as alpha-1 antitrypsin, immunoglobulins and convalescent plasma, to treat different stages of COVID-19. This includes patients with mild symptoms who stay at home, hospitalized patients and severe cases requiring intensive care.
The anti-SARS-CoV-2 hyperimmune globulin is one of the treatments for patients whose respiratory symptoms require hospitalization but not intensive care. Grifols is also leading studies with alpha-1 antitrypsin and immunoglobulins for hospitalized patients with different disease progression, or requiring intensive care, in the U.S. and Spain.
For patients needing intensive care and treatments that reduce their viral loads, inflammation and respiratory distress, Grifols is sponsoring trials in the U.S. and Spain in which these patients receive convalescent plasma and high doses of intravenous immunoglobulin.
"Grifols has responded with a high sense of urgency to this public health emergency, proudly having established, in a short amount of time, a large-scale convalescent plasma collection program to produce important clinical volumes of an anti-SARS-CoV-2 hyperimmune globulin to treat patients," said Eduardo Herrero, president of Grifols' Bioscience Industrial Division.
"Grifols is very hopeful that all the clinical trials it is leading or participating in across different COVID-19 disease stages will advance as quickly as possible and prove to be successful," said Víctor Grífols Deu, co-CEO of Grifols.