Anti-SARS-CoV-2 hyperimmune globulin therapy is being developed by Grifols in collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and other federal public health agencies for the treatment of COVID-19 infections. The polyclonal antibodies candidate, based on Grifols' immunoglobulin Gamunex®-C, uses plasma from convalescent COVID-19 patients. This therapy is designed to provide a highly specific, pure treatment that offers a consistent concentration of neutralising antibodies against the SARS-CoV-2 virus. The therapy aims to boost the immune system's response to the virus, especially in patients with weakened immune systems, by delivering concentrated antibodies directly to combat the infection. Clinical development is underway in the US, the UK, Denmark, Germany, Greece, Japan, Nigeria, and Spain

Grifols is exploring strategic collaborations for hyperimmune globulin therapy in Europe ^[1] .

In March 2020, Grifols entered into a collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and other Federal public health agencies to collect plasma from convalescent COVID-19 patients and to process this specific plasma into a hyperimmune globulin to support the preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy to treat COVID-19 disease. Grifols will volunteer its expertise and resources in the areas of plasma collection using its network of FDA-approved plasma donor centers; test and qualify donors in conjunction with other health agencies, to process plasma into hyperimmune globulin in its purpose-built facility. This unique collaboration will provide the opportunity to validate a therapy that, if proven effective, can be used today in the face of the COVID-19 pandemic and for future outbreaks of novel emerging viruses. ^[2]

In February 2022, Grifols terminated a phase III trial which was designed to compare the efficacy of anti-COVID-19 immune globulin (human) 20% (C19-IG 20%) (two doses) as compared with placebo with regard to the percentage of asymptomatic patients who remain asymptomatic, that is, who do not develop symptomatic COVID-19 infection through Day 14 as per the protocol defined criteria, due to futile outcome (NCT04847141; EudraCT2021-000269-34; GC2010). The double-blind, multicentre, parallel, prospective, randomised trial was initiated in April 2021 and enrolled 465 patients in Spain ^{[3] [4]} .

In April 2021, Grifols announced that the phase III ITAC (INSIGHT-013) trial did not meet its primary endpoint of ordinal outcome based on the patients' clinical status on Day 7 in each group, with seven mutually exclusive categories ranging from no limiting symptoms due to COVID-19, to death (NCT04546581; INSIGHT013; EudraCT2020-002542-16). In May 2021, the University of Minnesota in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institutes of Health (NIH) completed the phase III ITAC (INSIGHT-013) trial designed to evaluate the safety, tolerability and efficacy of anti-coronavirus hyperimmune intravenous immunoglobulin for the treatment of adult hospitalized patients at onset of clinical progression of COVID-19. The randomised double-blind, placebo-controlled trial was initiated in October 2020 and enrolled 593 patients in the US, Denmark, Greece, Germany, Japan, Nigeria, Spain and the UK ^[5] . Emergent BioSolutions, Grifols and, CSL Behring with Takeda provided anti-coronavirus hIVIG for the trial. In April 2021, Grifols released topline data from the trial ^{[6] [7]} .

As of July 2020, Grifols is working on a clinical study of hyperimmune globulin using convalescent plasma collected in Europe ^[8] .

As of March 2020, Grifols is working on a clinical trial with inactivated plasma from recovered patients (methylene blue) through a collaboration with select donation centers and public hospitals for the treatment of COVID-2019 infections in Spain ^[2] .

Financing information

As of October 2020, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has sponsored and funded the phase III ITAC trial [see above] ^[7] .