Six months after being welcomed by Trump administration officials as a “breakthrough” therapy to combat the worst effects of COVID-19, convalescent plasma is on the ropes. I can see.
Treatment of injecting plasma from recovered COVID-19 patients into newly infected people in the hope of boosting their immune response did not respond to early hype. Some well-known clinical trials have shown disappointing results. Hospital demand for antibody-rich plasma has plummeted. Long-time supporters of treatment after a year of extensive national efforts to recruit recovered COVID-19 patients as donors and the collection of more than 500,000 units of COVID-19 convalescent plasma known as CCP. Say they are pessimistic now that future.
“I’m worried that the CCP train has left the station,” said Dr. Michael Busch, director of the Vitalant Research Institute, one of the largest blood center-based transfusion medicine research programs in the United States. Studies have come out and they say things like this didn’t work in the first place. “
But that feeling is by no means universal. Other respected supporters say we are monitoring scientific progress in real time, and it is premature to count convalescent plasma. Large studies that employ more calibrated doses of convalescent plasma and more targeted patient groups during a set period of their illness meet the criteria for progress and are promising. It states that there may be.
Dr. Julie Katzkarp, Director of Transfusion Medicine at Thomas Jefferson University Hospital in Philadelphia, said: “People do a good job of reading literature, but one week the answer is” yes “and the next week” maybe not. ” “
Convalescent plasma is for emergency use last August, despite opposition from federal scientists warning the Food and Drug Administration under political pressure that no cure has been proven. I was pushed into a national conversation when I made the decision to approve the treatment. Since then, tens of thousands of Americans have been infused with plasma.
Enthusiasm has diminished in recent weeks after two serious retreats: a large federal clinical trial called C3PO recovered in high-risk patients who came to the emergency room with mild to moderate COVID-19 symptoms. Tested the use of stage plasma. The researchers concluded that the infusion was harmless, but unlikely to benefit the patient. That same week, a pooled analysis of 10 convalescent plasma studies published at JAMA found no clear benefit.
In January, the FDA reduced the emergency use authorization for convalescent plasma and restricted it to COVID-19 patients who were hospitalized in the early stages of the disease and those with a medical condition that impaired immune function. Authorities also said that after May 31, only plasma containing antibodies that fight high levels of the virus would be available.
At the same time, the COVID-19 surge that involved the United States throughout most of the winter was mitigated, sending demand for a convalescent plasma plunge. Hospital injections dropped from a high of about 30,000 units per week at the beginning of the year to about 7,000 units per week in early March.
To make matters worse, the $ 646 million worth of federal contract paid to the US blood center to collect COVID-19 convalescent plasma is about to expire, and the complex process of collecting plasma is still worth the effort. We urge centers across the country to reconsider whether or not. As complexity increases, blood centers will be refunded $ 600- $ 800 per unit of COVID-19 products. In contrast, the price of a regular unit of fresh frozen plasma is $ 100.
Dr. Lewis Katz, Chief Medical Officer of the Mississippi Valley Regional Blood Center in Davenport, Iowa, said: “I don’t want to collect unfamiliar products, so it costs more.”
American Red Cross officials have suspended direct collection of convalescent plasma due to the FDA’s revised Emergency Use Authorization and changes required by the “evolving” market. People previously infected with COVID-19 may still donate whole blood, and units tested positive for high levels of antibodies can be used as CCPs.
Even if they admit frustration, plasma proponents say it would be a silly overkill to declare its death in just a few months of research. The idea of ​​using plasma from recovered patients to treat new illnesses has been ly adopted during many epidemics, including the catastrophic 1918 flu, the outbreak of measles in the 1930s, and more recently Ebola. It is a concept that has been used 100 years ago.
A Mayo Clinic-led program that supplied convalescent plasma to more than 100,000 US patients last year, saying scientists need to improve convalescent plasma usage and ease expectations, rather than abandon efforts. Said Dr. Michael Joyner, a senior researcher at.
“This is a non-standardized dose of a non-standardized product given to all visiting patients due to a disease with variable progression,” Joiner said in an email. “Therefore, it is impractical to expect the results of a cookie cutter as you would get in a statin / heart attack test.”
Joiner and colleagues continued to point out promising research. In mid-February, Argentine scientists said that administration of very high levels of antibody to convalescent plasma within 3 days of the onset of mild COVID-19 symptoms helped slow the progression of the disease in older patients. I reported. In mid-March, researchers in the United States and Brazil reported in a study that had not yet been peer-reviewed that plasma therapy did not improve hospitalized symptoms in patients with severe cases of COVID-19. However, it was associated with a 50% reduction in deaths “may need further evaluation” after 28 days, the authors wrote.
This month’s Oversight Committee endorsed two federal-funded clinical trials of convalescent plasma to continue enrollment of hundreds of patients. One, led by researchers at Johns Hopkins University, is testing convalescent plasma in people who have been infected and developed symptoms of COVID-19 but were not hospitalized. The other is testing the strong plasma of inpatients, led by scientists at Vanderbilt University.
Dr. David Sullivan, a professor of molecular microbiology and immunology at Johns Hopkins University and a senior researcher in plasma testing at the institution, has no doubt that “antibodies act against viruses.”
“It’s all about dose and time,” Sullivan said, adding that it is important to give high levels of antibody to convalescent plasma within the first few days of infection.
Dr. Michael Knudson, co-medical director at the DeGowin Blood Center at the University of Iowa’s Carver College, said the most promising uses of convalescent plasma could come from “super donors” infected and vaccinated with COVID-19. Stated. medicine.
Knudson shows that his early studies can provide plasma from people who have been vaccinated after recovery 5 to 20 times more neutralizing antibodies than plasma from people who have not been vaccinated. Said. “This will be a product that is almost completely different from what has been used so far,” he wrote in a presentation to his colleagues.
Joiner et al. Have found that “boosted” plasma is a powerful antiviral treatment early in the infection, similar to the use of monoclonal antibodies (laboratory-made proteins that act like human antibodies in the immune system). I believe it can be used as. This could be a cheaper option for resource-poor countries that cannot afford monoclonal therapy in excess of $ 1,200 per dose.
Even Dr. Simone Glynn and Dr. Naheed El Kasser, scientists at the National Institutes of Health conducting a discontinued C3PO trial, agreed that more data on the usefulness of convalescent plasma was needed. “The answer is no, it’s not the last word,” they said in an email statement.
However, given the recent results of roller coasters, it is not easy to overcome skepticism about the use of all types of convalescent plasmas, not to mention “super” plasmas. And widespread use of convalescent plasma will depend on continued funding. If the federal contract with the blood collector is not renewed, COVID-19 convalescent plasma may be paid by a hospital or private insurance company, depending on where the patient is treated.
Meanwhile, the federal government continues to fund Hopkins and Vanderbild trials, along with academic centers and private donors. In addition, the Federal Office for Advanced Biomedical Research has become a commercial company that collects COVID-19 convalescent plasma from paid donors to produce hyperimmunoglobulin, a purified and concentrated plasma that has the potential to stop the disease. Allocated at least $ 27 million. The results of late-stage clinical trials of that treatment are expected later this spring.
Dr. Claudia Korn, Chief Medical Officer of AABB, an international non-profit organization focused on transfusion medicine and cell therapy, said: “There is some evidence that it works and that it can produce high titers of plasma. Let’s see what we can do to keep people away from the hospital.”
(KHN (Kaiser Health News) is a national news room that produces detailed journalism on health issues. KHN is one of the three major operating programs of the KFF (Kaiser Family Foundation), along with policy analysis and polling. . KFF is a donated non-profit organization. An organization that provides the country with information on health issues.)
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