POTENTIAL COVID-19 PLASMA THERAPIES IN CLINICAL TRIALS

Grifols is leading or participating in more than 25 initiatives researching potential treatment options for different COVID-19 disease stages, including several clinical trials with plasma-derived medicines and convalescent plasma.

Grifols is currently investigating an anti-SARS-CoV-2 hyperimmune globulin for its potential to provide neutralizing antibodies against the SARS-CoV-2 virus. It's an immunoglobulin containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease.

The first international multicenter clinical trial evaluating its safety, efficacy and tolerability as a potential treatment for COVID-19 hospitalized patients started in October 2020.

The phase 3 trial, known as Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC), is randomized, double-blind, placebo-controlled and adaptive and will include 500 hospitalized adults with COVID-19 in up to 58 hospitals covering 18 countries, including the United States and Spain.

Researchers will determine if giving the anti-SARS-CoV-2 hyperimmune globulin intravenously when COVID-19 symptoms first appear can augment the natural antibody response to SARS-CoV-2, thereby reducing the risk of more serious illness and death.

This trial is part of a collaboration with U.S. government agencies such as the Food and Drug Administration (FDA) and the Biomedical Advanced Research Development Authority (BARDA). It is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).

Another clinical trial will start in February in Spain in collaboration with the researchers Oriol Mitjà and Bonaventura Clotet from Germans Trias i Pujol Hospital in Badalona (Barcelona). It will include 800 asymptomatic SARS-CoV-2-positive patients who will receive the immunoglobulin subcutaneously on an outpatient basis. The treatment would provide immediate protection after exposure to the virus and could be used to complement the vaccine in the early phase after vaccination.

The anti-SARS-CoV-2 hyperimmune globulin is manufactured at our facilities in Clayton, North Carolina, especially equipped for the production of plasma-derived medicines for infectious diseases. Grifols collects convalescent plasma through its industry-leading network of plasma-collection centers in the U.S. and Germany, as well as through a collaboration with blood banks in Spain.

Grifols is currently conducting several clinical trials in Spain and the U.S. with convalescent plasma from recovered COVID-19 donors for direct transfusion. The trials are in collaboration with health regulatory agencies, selected blood banks, transfusion centers and public hospitals.

The studies will evaluate the safety and efficacy of convalescent plasma in reducing viral loads, inflammation and respiratory distress in COVID-19 hospitalized patients requiring intensive care.

Convalescent plasma was approved for emergency use by the FDA on August 23, 2020, to treat hospitalized patients with COVID-19.

Grifols is currently collaborating with different experts, academics, hospitals and researchers across the U.S. and Europe in several clinical trials to determine if plasma-derived medicines already used for other medical conditions can also treat patients with COVID-19.

These products include alpha-1 antitrypsin, immunoglobulins and antithrombin III, whose efficacy in reducing inflammation and respiratory distress is being evaluated in hospitalized patients with different disease progression, including those requiring intensive care.

If you have recovered from COVID-19 and would like to donate plasma and help fight the pandemic, please consider giving your plasma at a donation center or blood bank near you.

Now more than ever, we are extremely grateful to those who donate.