Antibody treatment trial paused
A government- sponsored clinical trial testing an antibody treatment made by the drug company Eli Lilly has been paused because of a “potential safety concern,” according to emails that government officials sent on Tuesday to researchers at testing sites, and confirmed by the company. The news comes a day after Johnson & Johnson announced the pause of its coronavirus vaccine trial because of a sick volunteer, and a month after AstraZeneca’s vaccine trial was halted over concerns about two participants who had fallen ill after getting the company’s vaccine.
The Eli Lilly trial was designed to test the benefits of the therapy on hundreds of people hospitalized with COVID- 19, compared with a placebo. All study participants also received another experimental drug, remdesivir, which has become commonly used to treat patients with COVID- 19. It is unclear how many volunteers were sick, or any details about their illness.
In large clinical trials, such pauses are not unusual, and illness in volunteers is not necessarily the result of the experimental drug or vaccine. Such halts are meant to allow an independent board of scientific experts to review the data and determine whether the event may have been related to the treatment, or occurred by chance.
Enrollment for the Eli Lilly trial, which was sponsored by several branches of the National Institutes of Health and the Department of Veterans Affairs, among others, had been ongoing. But emails sent Tuesday from multiple officials told researchers to stop adding volunteers to the study out of an “abundance of caution.”
The NIH and the VA did not immediately respond to requests for comment.