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CSU starts FDA approved research on convalescent plasma

Scientists at Colorado State University’s Infectious Disease Research Center are now studying COVID-19 antibodies and their possible effects on patients infected with the disease. The Food and Drug Administration recently authorized convalescent plasma research as a way to treat COVID-19. 

Izabela Ragan, a postdoctoral fellow in the department of biomedical sciences at CSU, wrote in an email to The Collegian that antibodies are proteins the immune system produces to fight off invaders like bacteria and viruses. Ragan wrote that antibodies will find, attach to and stop the invader’s ability to replicate and spread. 

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“Once bound to the antigen, antibodies activate other aspects of the immune response to help destroy the invader,” Ragan wrote. “Our immune system produces several types of antibodies like IgG, IgA and IgM; each has a unique job, but they work together to attack.”  

“It might serve as a way to prevent the disease from spreading, or at least increasing or being as severe, until their own immune system is able to start generating the antibodies and cellular immune responses on its own to fight off the disease.”-Raymond Goodrich, IDRC executive director

Ragan also wrote that a patient develops antibodies found in the plasma portion of whole blood after recovering from SARS-CoV-2, the virus that causes COVID-19.

“Plasma with the anti-SARS-CoV-2 antibodies can be collected from a donor who has recovered from COVID-19 using a process called apheresis,” Ragan wrote. “The collected convalescent plasma can then be transfused back into COVID-19 patients with severe disease to boost their immune system and fight off the virus.”

Raymond Goodrich, executive director of the IDRC, said that antibodies taken from someone who has already survived the disease could be used in the early stages of someone else’s infection.

“It might serve as a way to prevent the disease from spreading, or at least increasing or being as severe, until their own immune system is able to start generating the antibodies and cellular immune responses on its own to fight off the disease,” Goodrich said. 

Goodrich said that this concept is not new and has actually been around for close to 100 years. 

“It was even used during the first influenza pandemic back in 1918-19 to treat patients with influenza,” Goodrich said. “It’s been used in other diseases like SARS-CoV-2 or like that influenza virus, usually in the very early stages of the spread of the disease.”

Goodrich said that risk factors exist, such as allergic reactions, but said those can be easily dealt with. He also said that the benefits of receiving the therapy outweigh the risk factors.

“I think that for the most part, the complications that are associated with using it are very similar to the complications associated with just giving plasma for transfusion purposes,” Goodrich said. “So the risk from a safety standpoint is relatively low.” 

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Goodrich said that the track that this study took is not the typical track one would take to get a therapy approved by the FDA. He said that, after proving its safety through preclinical testing, normal medical trials would then go into human trials.

Goodrich said that the third phase of human trials is to prove whether or not the new therapy has an effect. 

“I think all the people affiliated and associated with CSU should be proud as well, and certainly the people in the state of Colorado for having this asset here.” -Raymond Goodrich, IDRC executive director

“Those are usually people who are suffering from the disease,” Goodrich said. “You administer it, and some of the people in the study get the treatment and some of the people in the study don’t.”

Goodrich said that the people participating in the trial aren’t aware if they have received the treatment or not. This is to test the effectiveness of the new therapy or drug versus the placebo effect. Goodrich said that the convalescent plasma trials at CSU did not enter this phase. 

“You have people who are dying,” Goodrich said. “Is that the time that you can practically, or even ethically, go to a patient or go to a family member of that patient and say, ‘Would you like to enroll your loved one, or would you yourself like to enroll in a clinical trial? And there’s a 50-50 chance that you may get a placebo. We think this may work, but you may not get it; you may get a placebo.’”

Goodrich said that most physicians would just want to save a person’s life. He said that, since studying convalescent plasma is not new, the FDA was able to use an emergency use authorization to treat patients with the therapy. 

“The requirements for an emergency use authorization are a little bit different,” Goodrich said. “You have to show that it’s safe. You have to have some evidence of efficacy. But the evidence is more along the lines of, say, this might have a benefit.”

Goodrich said that the historical knowledge and data that was provided on plasma research in the past has shown evidence that this therapy treatment has a benefit. He said this is why the FDA has decided to approve an emergency use authorization.

According to a press release from the FDA website, the emergency use authorization was issued in August. 

The press release said that the authorization allows COVID-19 convalescent plasma to be distributed in the U.S. and used by health care providers when appropriate to treat patients who have COVID-19. 

“Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met,” the press release said. 

Goodrich said that CSU got engaged with multiple hospitals and blood centers across Colorado to develop tests to fight the disease. He also said that CSU hosts laboratories that can help these centers and hospitals develop tests to study antibodies and their effect on the disease. 

Goodrich said that there have been multiple efforts at CSU to research and help cure the disease, including the development of vaccines, diagnostics and the evaluation of new therapeutics. 

“I think everyone is very proud of the contribution that CSU has been able to make and continues to make in these areas,” Goodrich said. “I think all the people affiliated and associated with CSU should be proud as well and certainly the people in the state of Colorado for having this asset here.”

Ceci Taylor can be reached at news@collegian.com or on Twitter @cecelia_twt.

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