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Thursday, October 22, 2020

Eli Lilly Covid-19 Antibody Treatment Trial Is Paused Due To ‘Potential Safety Concern’

Topline

Eli Lilly on Tuesday confirmed to the New York Times that a clinical trial for its antibody treatment for Covid-19 has been paused because of a “potential safety concern,” just one day after Johnson & Johnson halted its Covid-19 vaccine trial because a participant got sick.

Key Facts

Eli Lilly is testing how hundreds of people hospitalized with Covid-19 react to its antibody therapy compared with a placebo; all study participants also receive the experimental drug remdesivir.   

Multiple government officials reportedly sent emails to researchers Tuesday to tell them to stop enrolling new participants out of an “abundance of caution,” according to the New York Times.

Eli Lilly spokesperson Molly McCully told the Times the company supports the decision the independent oversight committee Data and Safety Monitoring Board made to pause the study to “cautiously ensure” the safety of participants. 

It is unknown how many participants got sick or symptoms they experienced.

Further Background

It is not uncommon to pause large clinical trials to give an independent board a chance to review the data and determine if volunteers got sick as a result of the experimental drug or vaccine. Johnson & Johnson on Monday announced it paused its Covid-19 vaccine trial because a volunteer got sick. AstraZeneca paused its Covid-19 vaccine trial in early September after a participant fell ill. 

Tangent

President Trump has promoted the experimental antibody therapeutics made by Regeneron and Eli Lilly since being treated for Covid-19. Trump has claimed his treatment was a “cure,” and he has said positive things about Eli Lilly’s antibody therapy in recent videos. Trump has suggested Regeneron and Eli Lilly’s drugs will be authorized for widespread use very soon. Regeneron and Eli Lilly have applied for emergency clearance from the Food and Drug Administration.  

Further Reading

Eli Lilly antibody trial is paused because of potential safety concerns (New York Times)

Johnson & Johnson Halt All Covid-19 Vaccine Trials Over ‘Unexplained Illness’ (Forbes)

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K. (STAT)

‘I Call That A Cure’: Trump Touts Regeneron’s Experimental Covid Treatment, Promises It Will Be ‘Free’ (Forbes)

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