Up to 45 coast-to-coast hospitals have expressed an interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, lead investigator Dr. Todd Rice.
A panel of the National Institutes of Health earlier this week disagreed with the FDA’s decision, saying that therapy “should not be considered the standard for treating patients with COVID-1
“It’s an important scientific question that we don’t have the answer to yet,” said Rice, associate professor of medicine and director of VUMC’s medical intensive care unit.
Convalescent plasma takes an antibody-rich blood product from people who have recovered from a viral infection and injects it into people who are still suffering in the hopes that the therapy will boost their immune systems and improve their ability to fight the virus. The approach has been used experimentally to combat other virulent diseases for more than a century, including influenza, measles, Ebola, SARS, and H1N1 influenza from 1918.
Last month, NIH officials awarded $ 34 million to Rice’s study, the nation’s Passive Immunity Trial for COVID-19, called PassItOnII, which was also funded by country music superstar Dolly Parton. The study, which will enroll 1,000 adult hospital patients, could achieve its goals by the end of October. If there is any evidence of a likely benefit for COVID patients, it could change clinical practice immediately, Rice said.
Half of the participants will receive convalescent plasma with a high level of antibodies against diseases from a supply of more than 150 units of the product already collected, Rice said. The other half receives a placebo solution.
Even though the study started in April, registration was slow. The funding enables admission to more than 50 locations across the country. This has sparked new talks about participating in the study – and about not using the controversial FDA approval, said Dr. Claudia Cohn, director of the Blood Bank Laboratory at the University of Minnesota Medical School. She expected her institution to decide this week.
“I’d rather do it like not rejecting the FDA, just thinking long term,” said Cohn, who is also medical director of AABB, an international nonprofit that focuses on transfusion medicine and cell therapies.
Officials at Ohio State University’s Wexner Medical Center have chosen to participate in the study and are considering making it the “first option” for qualified COVID patients, said Dr. Sonal Pannu, assistant professor and pulmonologist.
“Many of the academic leaders believe that we should do the study and we would severely restrict EEA approval for emergency or EEA,” she said, noting the first patients could be enrolled soon. The plasma could continue to be used under the EEA to treat patients such as prisoners who cannot consent to participate in a clinical trial, she added.
This is the same stance the University of Washington takes, said Dr. Nicholas Johnson, an assistant professor of emergency medicine who is leading the study at the Seattle site. “We’re really interested in enrolling patients as the first option,” he said.
“On a number of occasions we have allowed clinical practice to stay ahead of science,” said Johnson. “We have learned this lesson a couple of times now.”
FDA officials did not respond to requests for comment.
Leading federal health agencies including NIH director Dr. Francis Collins and Dr. Anthony Fauci, the nation’s leading infectious disease doctor, initially resisted attempt to release the Convalescent Plasma EEA last month, telling the New York Times that the evidence was too weak.
Trump has criticized the FDA for moving too slowly to expedite the approval of treatments and vaccines for COVID-19. He announced the EEA on the eve of the Republican National Convention, calling it a “truly historic announcement”.
Exhibiting the EEA “puts the fate of clinical trials at great risk,” said Arthur Caplan, professor of bioethics at New York University School of Medicine. Since convalescent plasma is very scarce, it creates the conditions for disputes over access and makes sick patients less likely to take part in a study where they may be given a placebo.
“When you have the EEA, it starts damaging the trials,” Caplan said.
Given that the FDA has approved convalescent plasma for patients with COVID-19, hospitals that hesitate or refuse to provide it outside of a trial will face questions from families.
That creates “a very interesting and sensitive ethical problem,” said Cohn.
“If you are only committed to the randomized controlled trial, you are making a long-term commitment to science,” she said. “The question is, is it ethically inappropriate not to offer therapy that has been shown to be potentially beneficial?”
Johnson of the University of Washington said most patients were ready – even eager – to take part in clinical trials once they understood the need for rigorous scientific results.
And Caplan, the bioethicist, hailed the hospitals’ decision to minimize the EEA and focus on the study, calling it “a pretty brisk move”.
“It’s reasonable,” he said. “There will likely really be an answer to the question of whether COVID convalescent plasma is making a difference.”