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 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.”
In a statement sent over email, Molly McCully, a spokeswoman for Eli Lilly, confirmed the pause. “Safety is of the upmost importance to Lilly,” she said. “Lilly is supportive of the decision by the independent D.S.M.B. to cautiously ensure the safety of the patients participating in this study.”
The N.I.H. and the V.A. did not immediately respond to requests for comment.
The Midwest and West are driving a virus surge in the U.S. The Eli Lilly antibody trial is paused because of potential safety concerns, just a day after Johnson & Johnson announced the pause of its coronavirus vaccine trial because of a sick volunteer.
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