The Denver Post

Antibody treatment trial paused

- By Katherine J. Wu and Katie Thomas

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.

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