Major Ivermectin Study Omitted Hundreds of Participants, Researchers Say

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The 2023 paper left out more than 200 participants.

A large study examining ivermectin against COVID-19 included more participants than was reported in 2023, researchers acknowledged in a new correction.

A U.S. government-funded trial arm examining ivermectin was said to have included 1,206 participants, including 602 who received ivermectin. The actual number of participants was 1,432, with 708 receiving ivermectin, Dr. Suanna Naggie, the study’s lead author, said in a May 16 letter to the editor announcing the correction.

“The blinded statistical team made an error in the implementation of exclusion/inclusion criteria such that 106 participants in the ivermectin group and 120 participants in the placebo group who should have been included in the analysis cohort were not,” Dr. Naggie said.

She said the mistake stemmed from excluding participants who were listed as missing “study completion status.”

“During the review process, staff in the unblinded statistical team did not identify the erroneous exclusion and thus the issue was not elevated for review,” according to Dr. Naggie, who said she was writing on behalf of her co-authors.

Dr. Naggie did not respond to requests for comment.

Dr. David Boulware, a scientist with the University of Minnesota and one of the co-authors, told The Epoch Times in an email that the error was identified when researchers were reporting the results from clinicaltrials.gov and found “that number of participants did not match up with the original publication, which then prompted further internal review in order to determine the source of the error.”

Dr. Naggie apologized to readers of the Journal of the American Medical Association, which published the study online on Feb. 20, 2023, and said researchers went back over the data to make sure there were no additional problems. She said future studies will include a protocol to avoid the error.

The study reported the results of a trial examining whether approximately 600 micrograms/kilogram of ivermectin daily improved time to recovery from COVID-19 in adults aged 30 or older. Limitations included participants being monitored remotely. The 661-word conflict of interest section declared payments from Johnson & Johnson and other pharmaceutical companies. The study was part of ACTIV-6, a government-funded set of trials examining various drugs against COVID-19.

By Zachary Stieber

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