Ballad’s role in blood plasma COVID-19 study unaffected by FDA ruling

A doctor holds a bag of blood plasma donated by a COVID-19 survivor at at blood bank in La Paz, Bolivia, in June.

A doctor holds a bag of blood plasma donated by a COVID-19 survivor at at blood bank in La Paz, Bolivia, in June.

The U.S. Food and Drug Administration has reportedly put a hold on granting emergency authorization to use blood plasma as a treatment for the novel coronavirus, though the Mayo Clinic research study that Ballad Health is a part of won’t be affected.

According to the New York Times, the FDA was preparing to issue an emergency authorization for the treatment before a group of top health officials — including National Institutes for Health Director Dr. Francis Collins and Dr. Anthony Fauci, the nation’s top infectious disease expert — intervened, saying the results of the study weren’t strong enough to justify emergency approval.

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” H. Clifford Lane, clinical director at the National Institute of Allergy and Infectious Diseases, told the Times.

In a statement to the Press, a Mayo Clinic spokesperson said the program is not intended to be a clinical trial and they chose to share their data because they “observed possible signals of efficacy.”

“The data could advance the discussion about the efficacy of convalescent plasma treatment, and we acknowledge that additional scientific investigation is needed,” the statement read. “The FDA has asked for additional data for review by their teams, and Mayo Clinic is providing that data. The discussion and simultaneous analyses continue. We welcome that further review.

“We agree on the need for randomized clinical trials as a scientifically sound approach,” the statement continued. “We believe the data from the EAP is significant and could be used to provide evidence to conduct RCTs going forward. We will always support bolstering the best science that will result in the most effective treatment for patients and welcome methodical scrutiny of our data.”

East Tennessee State University’s Infectious Diseases Division chief, Dr. Jonathan Moorman, said data from the convalescent plasma studies have not yet proven its efficacy, saying “it’s never really been tested in a randomized, placebo-controlled way as yet,” but that he thinks it will be.

“I think there’s multiple small studies out there that look like it could be effective, but none of them are really placebo-controlled,” Moorman said, later noting that some of the data out of the Mayo (Clinic) study suggests some effect, but it’s not an overwhelmingly convincing study as yet to show that it actually works. “I have optimism about it, you know with one good clinical trial we can answer the question, but I don’t think the answer is really out there yet.”

The treatment uses blood plasma donated by people who have recovered from COVID-19, which is then given to patients.

with the hope that the antibodies in the plasma will help patients fight off the virus, and keep those who aren’t severely ill from reaching that point. According to the most recent data published from the Mayo Clinic’s study, more than 35,000 patients — 52.3% of whom were in intensive care — received the treatment as part of an expanded access program designed to “explore the potential signals of efficacy” of the treatment.

The data suggested that the treatment was most effective when given within three days of diagnosis and when the plasma had a higher amount of antibodies. After one week, those who were given the plasma within three days had a mortality rate of 8.7%, compared to 11.9% in those who received it later. After a month, those numbers jumped to 21.6% compared to 26.7%.

Back in April, Ballad Health announced it would be taking part in the Mayo Clinic’s “game-changer” study, with the system’s Chief Clinical Officer Amit Vashist calling it a “very exciting development” at the time. As of Friday, Ballad Health has treated 260 patients with donated plasma, and had seen its donations triple in a matter of weeks. During a press conference on Aug. 12, Ballad’s Chief Physician Executive, Dr. Clay Runnels, called the increase in donations “really impressive” and expressed promise in the treatment while cautioning that they don’t know how effective it is yet.

“We can’t say exactly, accurately, how effective convalescent plasma is until the national study that we’re a part of — the data is published,” Runnels said. “I can tell you, anecdotally, physicians don’t generally order things that they don’t think work, and so the growth of the use tells you a little bit automatically about how effective they and the patients are finding it.”

Runnels later added that it’s possible that anecdotal evidence isn’t accurate, “but what we’re seeing anecdotally right now is a pretty significant impact from our perspective and, more important, the prospective of the patients and the treating physicians.”

Called a possible “game-changer” by system leaders, Ballad Health will participate in a national study for a novel coronavirus (COVID-19) treatment.

Jonathan Roberts is a journalist and photographer with a love for iced tea and traveling. A graduate of East Tennessee State University, Jonathan has been with the Press since 2019 and is a member of the National Association of Hispanic Journalists.

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Source: https://www.johnsoncitypress.com/living/health-care/ballads-role-in-blood-plasma-covid-19-study-unaffected-by-fda-ruling/article_871829c6-e2fb-11ea-a42e-8b001bde8015.html