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. 

1. Anti-SARS-CoV-2 Hyperimmune Globulin

The anti-SARS-CoV-2 hyperimmune globulin is a highly specific, pure medicine that provides a high and consistent concentration of neutralizing antibodies against the SARS-CoV-2 virus. The first international multicenter clinical trial evaluating its safety, efficacy and tolerability as a potential treatment for COVID-19 started in October.

A phase 3 trial called Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC), it 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 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).

The anti-SARS-CoV-2 hyperimmune globulin,  derived from the plasma of healthy donors recovered from COVID-19, 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 U.S. plasma-collection centers and in collaboration with blood banks in Spain.

Moving decisively against
COVID-19

Grifols has over 100 years of extensive experience in the research, development and successful application of plasma-derived therapies, including hyperimmune globulins for the prevention and treatment of well-known diseases such as rabies and tetanus.

Anti-SARS-CoV-2 Hyperimmune Globulin

Plasma from recovered COVID-19 donors can be converted into a potential treatment containing high and consistent concentrations of antibodies.

2. Convalescent Plasma for Direct Transfusion

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 to treat hospitalized patients with COVID-19.

Methylene blue inactivation

Direct transfusion of convalescent plasma to COVID-19 patients might help treat the disease. Before transfusion, the convalescent plasma is pathogen-inactivated with methylene blue technology to ensure safety.

3. Existing Plasma-derived Medicines: Alpha-1 antitrypsin and Immunoglobulin

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 and immunoglobulins, whose efficacy in reducing inflammation and respiratory distress is being evaluated in hospitalized patients with different disease progression, including those requiring intensive care. 

Everything starts with donations

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.

Donate in the U.S.

If you want to be a donor and you live in the U.S. go to Grifols Plasma

Donate in Germany

If you want to be a donor and you live in Germany go to Haema

Donate in Spain

If you want to be a donor and you live in Spain go to BST

Grifols is proud to be part of a coalition of world-class medical and research institutions, blood centers, life-science companies, philanthropic organizations and COVID-19 survivor groups that has come together to mobilize tens of thousands of people in the United States who have recovered from COVID-19 to donate their plasma, which contains essential antibodies that have fought off the disease and could help others do the same.

 

 

Go to TheFightIsInUs.org

Highlights

From donors to patients

What makes Grifols unique is that people, from donors to patients, are at the heart of everything we do.

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What is plasma?

Human plasma is the liquid part of blood. It contains critical proteins responsible for important life functions.

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What is plasmapheresis?

A specialized procedure to collect plasma in which machines separate plasma from whole blood and return the blood cells to the donor.

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