"There was no significant benefit in our primary endpoint of resolution of symptoms in mild-to-moderate COVID-19 illness or any other endpoints," said lead investigator Dr. Adrian Hernandez, executive director of the Duke University Clinical Research Institute in Durham, N.C.
"Given these results, and in conjunction with an earlier arm of the study testing a different dose of ivermectin, there does not appear to be any role for ivermectin in treating mild-to-moderate COVID-19, especially considering other available options with proven reduction in hospitalizations and death," he said in a Duke news release.
Researchers from Duke and Vanderbilt University in Nashville, Tenn., randomized more than 1,300 participants to take either 600 mcg/kg per day of ivermectin or a placebo for six days, starting last February.
The trial had previously tested a dose of ivermectin at 400 mcg/kg per day for three days from June 2021 to February 2022 and found no clinically significant benefit for symptoms, hospitalizations or emergency room visits.
This latest study found no differences in mild-to-moderate symptoms between patients taking a placebo and those taking a higher dose of the drug.
"Public interest in ivermectin and its favorable safety profile supported testing it in this study to evaluate the benefits and risks in a rigorous manner," said Dr. Susanna Naggie, the Duke principal investigator overseeing the study’s clinical coordinating center.
While ivermectin is approved to treat parasitic infections, it is not approved by the U.S. Food and Drug Administration to treat COVID-19.
The latest findings have been submitted to a peer-reviewed journal. The study received funding from the U.S. National Institutes of Health.
The U.S. Centers for Disease Control and Prevention has more on COVID treatments and medications.
SOURCE: Duke University, news release, Dec. 19, 2022