NIH Halts Trial of Convalescent Plasma for Mild COVID-19
While the treatment seemed safe, no significant differences in outcomes were seen between patients receiving convalescent plasma or placebo
WEDNESDAY, March 3, 2021 (HealthDay News) -- A clinical trial evaluating the use of convalescent plasma in patients with mild-to-moderate COVID-19 symptoms has been halted because the treatment did not benefit them, according to the U.S. National Institutes of Health.
The NIH study included patients seen at an emergency department who reported mild-to-moderate COVID-19 symptoms for a week or less. However, "even if enrollment continued, this trial was highly unlikely to demonstrate that COVID-19 convalescent plasma prevents progression from mild to severe illness" in at-risk patients who seek emergency care but are not hospitalized, an NIH news release said.
The trial to assess the safety and effectiveness of the therapy began in August and included 47 emergency departments nationwide. Of the 900 adult patients it sought to recruit, 511 were enrolled before the trial was halted. Patients had at least one risk factor associated with severe COVID-19, such as obesity, high blood pressure, diabetes, heart disease, or chronic lung disease. But when they arrived at the emergency department, none were sick enough to be hospitalized.
Study participants received either convalescent plasma or a placebo. They were then followed to assess three outcomes: if they sought further emergency or urgent care, if they had to be hospitalized, or if they died within 15 days of entering the trial.
While the study found the treatment to be safe, the researchers found no significant differences in the three outcomes between those who received the COVID-19 convalescent plasma or the placebo. An independent monitoring board recommended halting the trial after a Feb. 25 meeting, and the study stopped enrolling new patients.