Eight months into the COVID-19 pandemic in the U.S., it remains unclear whether two of the most promising treatments actually work.
With a vaccine not expected until 2021, there’s an urgent need for effective therapeutics for COVID-19. Thousands of Americans are currently hospitalized, and the Centers for Disease Control and Prevention reported projections of up to 205,000 deaths in the U.S. by mid-September.
But the clinical trials necessary to provide that evidence for convalescent plasma and monoclonal antibodies have been fraught with delays and have had problems recruiting volunteers. Many trials are only beginning now, months into the pandemic, because researchers focused their early efforts on therapies, such as hydroxychloroquine, that didn’t pan out.
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Randomized, placebo-controlled clinical trials, considered the gold standard, evaluate whether a treatment works by comparing it to a placebo. At the outset, neither the researchers nor the participants know who is getting the real thing and who is getting the placebo.
That’s created challenges for researchers running the trials.
“There are people who say, ‘I don’t want to be a guinea pig. If you think this stuff works, why not give me the real stuff?’” as opposed to a placebo, said Dr. Shmuel Shoham, an associate professor of medicine in Johns Hopkins University School of Medicine’s infectious diseases division.
The idea behind both convalescent plasma and monoclonal antibodies is to provide the immune system with a boost to fight off the virus. Convalescent plasma refers to the antibody-rich blood product taken from patients who’ve already recuperated, and monoclonal antibodies are a synthetic version of those antibodies that could be mass-produced in a lab.
But tens of thousands of COVID-19 patients who may have been eligible for clinical trials evaluating these therapies have already received convalescent plasma through the expanded access program run by the Mayo Clinic, taking them out of the running to be a trial participant.
“Some of us jumped on that bandwagon quickly,” Dr. Ashok Balasubramanyam, vice president for academic integration and senior associate dean for academic affairs at Baylor College of Medicine, said, citing early evidence from China that suggested a therapeutic benefit to convalescent plasma.
“The program was very liberal,” Balasubramanyam said. “Anybody could sign on to it and get rapid FDA approval.”
That’s not necessarily a bad thing during a pandemic in which millions of Americans have been infected. Convalescent plasma has a long history of use for other illnesses and is considered safe overall.
If it’s unlikely to hurt, and indeed might help, many patients opt to get the plasma.
Shoham and his colleagues at Johns Hopkins are leading a nationwide clinical trial effort to learn whether convalescent plasma can either prevent the illness or keep infected people well enough to stay out of the hospital.
But fewer than 100 participants…