MONDAY, June 13, 2022 (HealthDay News) -- Yet another study shows that ivermectin provides no benefits for COVID-19 patients, but researchers say they'll continue to study a higher dose of the drug.
Even though the drug used for parasitic infections in animals and people is not approved by the U.S. Food and Drug Administration to treat COVID-19, some have touted it as a therapy against the disease. The FDA warns against this and says large doses can be dangerous.
This double-blind study began in June 2021 and enrolled more than 1,500 participants with mild-to-moderate COVID-19 symptoms across the United States. They took 400 mcg/kg per day of ivermectin or a placebo for three days.
Over eight months, there was no difference in symptom relief or in the number of emergency room visits or hospitalizations between those who took ivermectin or the placebo, according to the findings on the pre-publication server medRxiv. The study has been submitted to a peer-reviewed journal.
"There was no significant benefit in our primary endpoint of resolution of symptoms in mild-to-moderate COVID-19 illness," said study principal investigator Dr. Adrian Hernandez, executive director of the Duke Clinical Research Institute in Durham, N.C.
"Overall, most people improved their symptoms whether they took ivermectin or not. Given these results, there does not appear to be a role for ivermectin outside of a clinical trial setting, especially considering other available options with proven reduction in hospitalizations and death," Hernandez said in a Duke University news release.
The researchers are still assessing a higher dose (600 mcg/kg) and longer use (six days) of ivermectin in COVID-19 patients.
The research is part of a study called ACTIV-6 that is examining the use of three repurposed medications in COVID-19 patients. Repurposed medications are those already approved by the FDA to treat other health conditions.
ACTIV-6 has so far enrolled more than 4,000 participants, with plans to include nearly 15,000 participants nationwide.
"The ACTIV-6 team will continue to study this higher dose to determine whether it will make enough of a difference to be considered for the treatment of mild-to-moderate COVID-19," said study co-author Dr. Susanna Naggie, also of the Duke Clinical Research Institute.
"We are committed to sharing these study results with participants, the public, and scientific community when they are available," Naggie said in the release.
For now, though, the FDA urges caution. It's possible to overdose on ivermectin, with symptoms including diarrhea, nausea, dizziness and even death. Also, the FDA said it has received reports of patients who have required hospitalization after self-medicating with ivermectin intended for livestock.
For more on COVID-19 treatments and medications, see the U.S. Centers for Disease Control and Prevention.
SOURCE: Duke University, news release, June 13, 2022