THURSDAY, May 21, 2020 (HealthDay News) -- Researchers at the NYU Grossman School of Medicine are conducting a phase II clinical trial to determine the efficacy of convalescent plasma in hospitalized patients with COVID-19. Corita R. Grudzen, M.D., vice chair for research in the Ronald O. Perelman Department of Emergency Medicine at NYU Langone Health, wrote the study protocol and recently spoke with HD Live! about the trial.
"What we hope to see is that convalescent plasma used in this stage of disease prevents patients from dying, going on a mechanical ventilator," or being admitted to the intensive care unit, Grudzen said.
The controlled, randomized trial, which started April 17 and is also being led by researchers from Montefiore Health System and Albert Einstein College of Medicine, will enroll 300 hospitalized patients ages 18 years or older from seven hospital centers. The researchers are enrolling patients within three to seven days after symptom onset. While other studies across the country are focusing on sicker populations, Grudzen said the research team felt strongly about enrolling hospitalized patients. "We know the earlier, the better," she said. As an emergency physician, she said, "many of us were seeing hundreds and now thousands of patients hospitalized, and so we really wanted to focus on that group. We know historically [that] the antibody binds to the virus in some way to prevent it from either entering the cells or from destroying whomever it's attacking. And so, the idea is to do that before there's an onslaught of the body's own inflammatory response."
Researchers at Johns Hopkins are focusing on populations even earlier in the disease, Grudzen said. They are conducting two convalescent plasma trials, one focused on high-risk populations of frontline health care workers and nursing home residents and another on outpatients with COVID-19 to prevent them from being hospitalized.
In Grudzen's trial, patients are randomly assigned in a 1:1 ratio to receive the anti-severe acute respiratory syndrome coronavirus 2 plasma or saline solution as a placebo. Grudzen said many patients and families are not aware of the risks of convalescent plasma, so there has been much discussion at the bedside about the risks for infectious disease and potential adverse reactions to the plasma. "Especially in older people, it's more risky," she said. The treatment is "not without harms, which is why we need to have lengthy, long discussions with patients and families about balancing the potential harms and potential benefits and making sure that they understand and have realistic expectations for what the plasma may or may not do."
At the time of the interview, Grudzen said the research team had enrolled about 100 patients. "The good news is we have less patients in the hospital with coronavirus; the bad news is that means we're having trouble finishing our research because we rely on infected patients to know whether things are working or not," she said. "The problem with research in infectious disease is precisely that."