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.
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.
“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…
One study site in Florida had to close, Shoham said, because clinical research coordinators there became too overwhelmed caring for COVID-19 patients. Others have had difficulty finding an appropriate space certified by a blood bank to do the infusions.
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