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October 14, 2020

Safety concerns temporarily halt Eli Lilly's COVID-19 antibody therapy trial

The National Institute of Allergy and Infectious Disease suspended enrollment for Eli Lilly's COVID-19 antibody therapy due to unspecified safety concerns Tuesday.

The news comes on the heels of the announcement that Johnson & Johnson paused its COVID-19 vaccine trial after a study participant suffered an unexplained illness. AstraZeneca's vaccine trial remains suspended in the United States due to a similar issue. 

The Phase 3 trial, known as ACTIV-3, has been enrolling participants who have been hospitalized with mild to moderate coronavirus infections with less than two weeks of symptoms. Each volunteer is randomly assigned to receive a placebo or an intravenous infusion of bamlanivimab, Lilly's antibody therapy, combined with the antiviral medication remdesivir.

The monoclonal antibody is synthetically made to strengthen the immune system's response to the SARS-CoV-2 virus.

Neither NIAID, which is sponsoring the trial, or Lilly has expounded on the specific safety concern. An NIAID spokesperson told Politico that "a predefined boundary for safety at day five" had been reached. 

The decision to stop enrolling more volunteers in the trial came from the data and safety monitoring board overseeing the trial. The trial has enrolled 326 patients. 

The board's role is to evaluate data from the first 300 participants before continuing enrollment. Of particular concern is their need for supplemental oxygen, and other types of supportive care five days after receiving the treatment or placebo.

Only the monitoring board has reviewed the trial data. NIH leadership and Lilly remain blinded to the results. The board will decide at a meeting on Oct. 26 if the trial will be allowed to add 700 more participants.

A company spokesperson told Politico that Lilly supports the decision "to cautiously ensure the safety of the patients participating in this study."

An NIAID spokesperson emphasized that the temporary halt is "out of an abundance of caution" and that data collection and follow-up will continue for those already enrolled in the trial.

Just last week, Lilly requested the U.S. Food & Drug Administration issue an emergency use authorization for the antibody treatment to be used in high-risk patients with mild-to-moderate COVID-19.

This request was based off preliminary data from a separate trial – a Phase 2 trial – that is exploring the effectiveness of using the antibody treatment before a patient's symptoms require hospitalization. 

Preliminary data from the Phase 2 trial shows that participants were less likely to need hospitalization if they received the antibody treatment. Antibody treatment appears to work best when given to people who have only been recently infected with the coronavirus, experts have observed.

All other Lilly studies focus on the use of the antibody treatment in earlier stages of the disease and remain ongoing. The company also is testing a cocktail of two monoclonal antibodies similar to the Regeneron treatment President Donald Trump received last week.

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