by Nancy Humphrey
Convalescent plasma, which is commonly given to critically ill patients hospitalized during the COVID-19 pandemic, does not improve their ability to survive or recover, according to a national clinical study led by Vanderbilt University Medical Center and published in the journal CHEST.
The multi-center, randomized, placebo-controlled Passive Immunity Trial for our Nation (PassITON) evaluated the efficacy and safety of COVID-19 convalescent plasma therapy in adults hospitalized with moderate to severe COVID-19 within 14 days of symptom onset became .
The rationale for using convalescent plasma in acute viral infections such as COVID-19 was that transfusing the plasma component of blood from a patient who has recently recovered from the same disease to a patient at an early stage of infection could care for the currently infected patient Antibodies against the infecting virus, which helps them recover faster.
“During this study, we were fortunate to have tremendous collaboration between thousands of people across the country, including patients, families, clinicians, study staff at 25 hospitals, and a wonderful team at VUMC,” said Wesley Self, MD, MPH, associate Professor of Emergency Medicine, Vice President for Clinical Research Networks and Strategy at VUMC and lead author of the study. “We asked a very specific question in this study: Does the transfusion of convalescent plasma, which is available to physicians in the US, at the time of hospital admission when a patient is critically ill with COVID improve the ability to recover and survive ? The answer is clearly no.”
“Providing passive immunity with convalescent plasma does not appear to benefit patients when their disease has progressed to the point where hospital treatment is required. Although convalescent plasma was obtained with a higher titer of neutralizing antibodies, the therapy did not help inpatients,” said Todd Rice, MD, MSc, associate professor of medicine, vice president of clinical trial innovation and operations at VUMC and senior author of the study.
In the study, 960 adults hospitalized with COVID-19 were randomized into two groups – those who received a unit of convalescent therapy and those who received a placebo. The results showed that the two groups had nearly identical clinical outcomes; 28 days after treatment, 18.5% of patients in the convalescent plasma group and 17.2% of patients in the placebo group had died.
The study was led by the Vanderbilt Institute for Clinical and Translational Research (VICTR). It was initially funded by the Dolly Parton COVID-19 Research Fund and then expanded to a multicenter study in September 2020 with funding from the National Center for Advancing Translational Sciences of the National Institutes of Health.
COVID-19 caused approximately 450 million cases and 6 million deaths worldwide in the first two years of the pandemic. From the start, convalescent plasma was heralded as a potentially promising treatment.
But instead of giving patients an unproven therapy, VUMC’s clinical and research company decided to take a safe and controlled approach, examining the evidence behind the idea that convalescent plasma would help.
“We decided that instead of jumping on the ship and giving recovery plasma to all of our COVID-19 patients in Vanderbilt, we decided to do a proper study,” Self said.
“VUMC is a true academic medical center and has designed, coordinated and/or participated in a large number of randomized clinical trials,” said Jill Pulley, MBA, research professor of medicine and executive director of VICTR. “This study examined an unproven intervention…it was beautifully performed, and while the results are unfortunate — we wish the therapy would work — they illustrate why studies are always necessary,” she said.
Although the VUMC study is the best-controlled study of COVID-19 convalescent plasma in hospitalized patients, other studies have been conducted in recent years that have shown similar results – this convalescent plasma as a therapy for patients suffering from COVID-19, at least as it is currently provided does not work. “It’s solid evidence,” he said.
For more than a year, VUMC has been enrolling patients and developing its own ‘pipeline’ of convalescent plasma with the help of Blood Assurance, a blood transfusion center.
Jillian Rhoads, PhD, VICTR’s senior scientific project manager, said blood for the convalescent plasma study at VUMC was collected and shipped to the other 24 hospitals participating in the study across the country.
“So many generous Vanderbilt employees and community members have donated plasma and really kept our study going,” she said. “It was amazing that they were able to donate enough plasma to enable a study with almost 1,000 patients and 25 centers.”