The National Institutes of Health (NIH) halted the Clinical Trial of Covid-19 Convalescent Plasma of Outpatients (C3PO) evaluating the safety and efficacy of Covid-19 convalescent plasma for treating patients presenting to the emergency department with mild to moderate disease.
“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,” NIH explained in a press release. “After the meeting, the DSMB recommended that the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, stop enrolling new patients into the study. NHLBI did so immediately.”
Last month the FDA issued a revision to its Emergency Use Authorization for Covid-19 convalescent plasma — which was initially issued in August 2020 and stirred up controversy when then-FDA Commissioner Stephen Hahn, MD, had to walk back claims overstating the treatment’s efficacy and NIH issued a statement arguing that there was insufficient evidence to support its use— to specify that only high-titer plasma should be used, and only among hospitalized patients early in the course of disease who have impaired humoral immunity.
C3PO first kicked off in August of 2020 across 47 hospital emergency departments across the U.S. The trial had recruited 511 of its 900-participant recruitment goal prior to the DSMB recommendation. Included patients had come to the emergency department with mild to moderate Covid-19 symptoms and had at least one known risk factor associated with progression to severe Covid-19 (obesity, hypertension, diabetes, heart disease, or chronic lung disease), but were not sick enough to require hospitalization.
Following convalescent plasma administration, researchers “tracked whether the participants needed to seek further emergency or urgent care, had to be hospitalized, or died within 15 days of entering the trial,” NIH wrote. “The recent data analysis from the study indicated no significant difference in the proportion of participants who experienced any one of these outcomes. 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 emergency department non-hospitalized participants.”
John McKenna, Associate Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,730,933,190,926,192,927,151,928,925,934