More than 2M deaths globally, stalled economies, record unemployment, social isolation, and the growing burden on overwhelmed hospitals and healthcare workers: That’s the true cost of the COVID-19 virus and resulting pandemic. As medical science continues to search for ways to prevent severe illness and death, Paysign has worked to stay abreast of the unfolding situation, potential treatments, and mitigation measures, as so many businesses have.
As a payments partner to the plasma collection industry since 2011, we have watched our source plasma collection partners work tirelessly providing the critical foundation that is used to develop numerous life-saving treatments.
Immunocompromised patients who might otherwise die without therapies derived from blood plasma collected by these partners have long benefitted from plasma donation. So, when the idea was first discussed earlier this year that a hyperimmune globulin derived from plasma may also fight against SARS-CoV-2, the disease caused by COVID-19, the significance of a potential therapy created from the antibodies of survivors sparked hope.
Hyperimmune globulin plasma therapies differ from convalescent plasma transfusions, which received an FDA emergency use approval earlier last year. The HIG treatment also uses plasma collected from recovered COVID-19 patients, but it is then further processed into a medicine with a larger antibody concentration and more consistent potency.
Paysign has had a front-row seat to these efforts, with our plasma partners advancing the development of these therapies at record speed, as we recently announced with ImmunoTek Bio Centers LLC.
Yet another partner, Grifols, S.A., a global leader in the development of therapies with plasma-derived proteins, announced a controlled clinical trial for its anti-SARS-CoV-2 hyperimmune globulin, which could be used for the treatment of the virus – either in concert with vaccines or alone.
“I don’t feel it is an overstatement to say that everyone on the planet wants to find a way to put COVID-19 in the past,” said Mark Newcomer, president and CEO of Paysign. “I think the average person has heard of convalescent plasma medicines at this point, but not many know what a powerful weapon they can be in the fight against this virus.”
We asked Vlasta Hakes, director of corporate affairs for Grifols, about what makes medicines created from plasma donation so powerful – and it starts with understanding what plasma is.
“Plasma is a portion of the blood that, essentially, is used as a starting material to create lifesaving medications,” she said.
Human bodies are designed to create the proteins and antibodies that allow our immune systems to identify and fight off pathogens. But some people, typically those with rare diseases, have compromised immune systems unable to make these lifesaving biological components. These people require medicine that will replace the antibodies and allow them to lead more normal lives.
“That’s where plasma donation comes in,” Hakes said. “Under normal circumstances, plasma is used to make medicines that contain antibodies that can help those with primary immune deficiencies. Now, the same idea is applying to the pandemic. By harnessing the antibodies of people who have beaten COVID-19, convalescent plasma medicines can provide aid on the front lines of this battle against the virus.”
The trial is the most recent stage of an initiative that began in March when Grifols partnered with U.S. government agencies, including the Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA), the National Institute of Allergy and Infectious Diseases, and the National Institutes of Health.
According to Hakes, the study is working to determine if giving the anti-SARS-CoV-2, 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, reducing the risk of more serious illness and death.
“The medicine is like a preliminary boost for the immune system as the body develops antibodies,” she said, “During that in-between period, while we’re waiting for the body to develop its own antibodies to fight the disease.”
The Grifols study is the first international multi-center 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 trial includes 500 hospitalized adults diagnosed with COVID-19 in up to 58 hospitals covering 18 countries, including the United States and Spain.
According to Hakes, 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 is excited about being a part of the solution,” Hakes said. “Even as there is still a great deal to learn about the virus.”
While the media has speculated that COVID-19 antibodies don’t appear to last, Hakes said there is not enough evidence to draw such a conclusion.
“We don’t know that antibodies don’t last, we are studying it,” she said. “People are eager for answers – so are we.”
Even though the rollout of COVID-19 vaccines has begun, they likely won’t be available to the masses until spring 2021, and we will have a long way to go before infection and hospitalization rates see the impact of immunity provided by the vaccines.
According to Hakes, the vaccine is great news, but it does not change the fact that convalescent plasma medicines still have a place in treatment protocols for COVID-19. Hakes said that people who have recovered from the virus should consider donating plasma now.
“It’s more important now than ever,” she said. “I encourage everyone who can to donate and save lives.”
Paysign, a longtime partner of Grifols, has built and refined a prepaid debit card program for the plasma collection industry that addresses their unique set of needs while motivating and rewarding source plasma donors to increase both the frequency of donations and retention of repeat donors. Visit paysign.com to learn more.