The National Institutes of Health said Eli Lilly’s trial of its COVID-19 antibody drug was halted due to the “clinical status” of multiple participants, according to a statement reviewed by The New York Times.
The trial was paused when an independent safety board found that, after five days of treatment, the group of patients who had received the antibodies showed a different “clinical status” than the group who received the placebo, and the difference crossed a predetermined threshold for safety. The NIH didn’t specify the nature of the participants’ conditions.
The trial’s protocol says it could be halted if there is evidence that patients in one group are faring much worse than the other group. Eric Topol, MD, a clinical trials expert at Scripps Research Institute in San Diego told the Times that, given the ambiguity of the NIH’s comments, all scenarios are possible.
The safety board will review the data again Oct. 26 and advise the NIH on whether to resume the trial, the NIH said. In the meantime, researchers will collect data from people already enrolled in the trial.
The trial had enrolled 326 COVID-19 patients, all of whom also received Gilead’s remdesivir. The patients received 7 grams of the antibody drug,10 times the dose that Eli Lilly is planning to use for patients who aren’t hospitalized, the Times reported.
The pause in the trial doesn’t affect other trials of the drug, which include studying it in people with milder cases of COVID-19 and studies of whether it can prevent infection among nursing home workers and residents at high risk of exposure to the virus.
Read the full article here.
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