FDA approves plasma trial
The agency gives the green light to a clinical trial using plasma from coronavirus survivors to protect those exposed and treat people who are already sick.
Federal regulators on Friday approved a clinical trial at Johns Hopkins University to test the use of plasma from recovered COVID-19 patients to treat doctors, nurses and other first responders who are at high risk of exposure to the new virus.
The news follows a nationwide effort by more than 100 researchers and at least 40 large hospitals to get clinical trials started using survivor plasma, a technique that has been used for more than a century to quell outbreaks of polio, measles, mumps and influenza.
The use of plasma on first responders who have been exposed to the novel coronavirus but have shown no symptoms of the disease "will tell us whether plasma is effective in protecting our health care workers and first responders from COVID-19,” said Arturo Casadevall, an infectious disease expert at Johns Hopkins Bloomberg School of Public Health and the Johns Hopkins School of Medicine in Baltimore. Casadevall has been one of the leaders of the national push for clinical trials of survivor plasma.
A press release from Johns Hopkins announcing the U.S. Food and Drug Administration decision did not say how soon the first clinical trial would begin.
The idea behind the technique is that plasma from COVID-19 survivors should be rich in virus-fighting antibodies. A patient receiving the plasma would immediately receive a large number of antibodies, rather than having to wait for their own immune system to generate them. The infusion of plasma does carry potential side effects, including fever, allergic reaction and a very small risk of infectious disease transmission.
To this point, there are no drugs or vaccines that have been proven to prevent or even treat COVID-19.
However, plasma is already being used in some hospitals for experimental compassionate care with the blessing of the FDA. Researchers should see some preliminary results on the effectiveness of that effort within days.
The effort called the National COVID-19 Convalescent Plasma Project centers on organizing and fast-tracking clinical trials at various institutions. The process usually takes years, but in the emergency of a pandemic, it is expected to move much faster.
The University of Wisconsin-Madison joined the project last weekend and is expected to host one of the clinical trials.
The work in Madison will be led by William Hartman, UW Health assistant professor of anesthesiology. Hartman said Madison will be one of the clinical trial sites, though he could not say how many patients will participate.
"I think we can be very hopeful in that it has exhibited success with previous coronaviruses including SARS (Severe Acute Respiratory Syndrome)," Hartman said, referring to the use of survivor plasma.
“Plasma transfusions are critically important and used every day to save lives of patients who are bleeding," Aaron Tobian, a professor of pathology, medicine and epidemiology at Johns Hopkins, said in a press release announcing the FDA approval.
"It is incredibly important for us to determine whether convalescent plasma will also be able to save the lives of individuals infected with COVID-19 and prevent infection of COVID-19.”
Trials would test three groups
The United Kingdom and Ireland have also joined the project to test the effectiveness of plasma from recovered COVID-19 patients as both a means to protect those who've been exposed to the virus and also to treat those sick with the disease.
The clinical trials would test at least three distinct groups of people: those who have been exposed to the virus that causes COVID-19, such as doctors, nurses, first responders and family caregivers; patients already hospitalized with the disease who have continued to grow sicker; and severely ill patients.
Organizers have already posted protocols for clinical trials on the project's website.
"The world is downloading it," Casadevall told The Milwaukee Journal Sentinel.
Last week, Casadevall's team was awarded $4 million for the research from Bloomberg Philanthropies and the State of Maryland. The large hospitals engaged in the project are collaborating with the American Red Cross, blood banks, Amazon and Federal Express.
Federal Express is working with the blood banks, which will need to test any plasma to ensure it is not tainted by Hepatitis B, HIV or other viruses.
Collecting plasma from recovered patients on a national scale will present a major challenge.
Although more than 275,000 people across the U.S. have been infected with the virus, a little under 10,000 are considered to have recovered. To be considered recovered from the virus, patients have to be symptom free for 14 days.
Survivor plasma showed promising results in a small Chinese study of five COVID-19 patients, published a few days ago in The Journal of The American Medical Association. The five patients, ranging in age from 36 to 65, were all on mechanical ventilation when they received the plasma. Four recovered from acute respiratory distress syndrome. At 37 days following the plasma infusion, three of the five patients had been released from the hospital; the other two were in stable condition.
"Nobody anticipates a Lazarus-like effect on the really ill," cautioned Michael Joyner, who has been working to set up trials at Mayo Clinic, where he works as a professor of anesthesiology. "What's more likely is that the slope of the patient's decline will gradually slow and that they can be weaned off of ventilation."
Joyner said clinical trials will likely begin at different times at different sites as the pandemic moves across the U.S.
“We are grateful and encouraged that researchers can move forward with this important research aimed at protecting those most at risk, our front-line health care providers and first responders,” said Ellen J. MacKenzie, dean of Johns Hopkins Bloomberg School of Public Health. “We also applaud the researchers' vision in the early stages of this pandemic to explore using blood plasma to treat critically ill patients.”