The National Institutes of Health has halted a clinical trial evaluating the safety and effectiveness of COVID-19 convalescent plasma in treating emergency department patients who developed mild to moderate symptoms of COVID-19, the disease caused by the coronavirus SARS-CoV-2.
An independent data and safety monitoring board (DSMB) met on Feb. 25, 2021 for the second planned interim analysis of the trial data and determined that while the convalescent plasma intervention caused no harm, it was unlikely to benefit this group of patients. After the meeting, the DSMB recommended that the NHLBI stop enrolling new patients into the study. NHLBI did so immediately.
"We do not see any sign that convalescent plasma had a benefit" in ER patients at risk for more serious disease, Simone Glynn, M.D., M.P.H., program scientist for the trial, told USA Today. She said that the data still needs to be analyzed before drawing any further conclusions about convalescent plasma’s effectiveness.
Nahed El Kassar, M.D., Ph.D., a program officer for the trial and a medical officer with the NHLBI, pointed out in the news article that a negative trial is still important. “You don’t do a clinical trial just to have a positive answer,” she said. "They have advanced the science, and because of them, we have what we have now, which is an answer to a very important clinical trial."