Eli Lilly's antibody trial is paused over potential safety concern

A "potential safety concern" has interrupted clinical testing of an antibody-based COVID-19 treatment developed by Eli Lilly, which is administering it plus remdesivir to trial volunteers.

A "potential safety concern" has interrupted clinical testing of an antibody-based COVID-19 treatment developed by Eli Lilly, which is administering it plus remdesivir to trial volunteers. A statement from NIH, a co-sponsor of the research, explained that enrollment was suspended after participants receiving the intervention demonstrated a different clinical response than controls who received placebo. That between-group difference, observed after 5 days of treatment, exceeded a prespecified safety threshold, although details on the affected volunteers' conditions were not disclosed. Researchers will continue to collect data from the 326 individuals already enrolled in the study while awaiting a recommendation from an independent data and safety monitoring board on the trial's future. Eli Lilly is one of several companies developing novel therapies for COVID-19 and is the third to experience trial setbacks after adverse events befell trial participants. Both Johnson & Johnson and AstraZeneca have had to shut down studies while evaluating vaccine candidates for the virus.