Researchers in the US and across the world have shown great interest in trying to find out if ivermectin, a cheap and widely used antiparasitic drug, could be effectively and safely used to treat COVID-19 patients. As of now, there are 77 studies assessing the use of ivermectin to treat or prevent COVID-19 registered in
clinicaltrials.gov, and 139 trials listed in the
WHO’s International Clinical Trials Registry Platform.
“Everybody wanted to do what they could when COVID first struck,” said Edward Mills, a Canadian researcher co-leading one of the largest clinical trials on repurposed treatments to be completed yet. “And those of us working in clinical research, we did what we could too.” Mills was speaking on Aug. 6 while
presenting the results for the first time during an event sponsored by the National Institutes of Health.
The
TOGETHER trial, co-led by Mills, professor of health research methods, evidence and impact at McMaster University in Canada, and Dr. Gilmar Reis, associate professor of medicine at Pontifícia Universidade Católica de Minas Gerais, Brazil, started in June 2020 and was set in 10 cities in the state of Minas Gerais, Brazil. This randomized adaptive platform trial started looking at the effectiveness of ivermectin for the treatment of COVID-19 among high-risk adult nonhospitalized patients on Jan. 15, 2021. The study analyzed whether patients’ health became worse and required hospitalization or more than six hours of observation in an emergency room, within 28 days of randomization.
According to the results presented, (35 slides
https://dcricollab.dcri.duke.edu/sites/NIHKR/KR/GR-Slides-08-06-21.pdf ), the study found no indication of benefit on the use of ivermectin – nor any with hydroxychloroquine or lopinavir-ritonavir, or metformin. The ivermectin arm had 1,500 patients: 677 of them received a daily dose of the medication, and 678 others were given a placebo, for three days. 86 patients in the ivermectin group required extended emergency room observation or hospitalization versus 95 in the placebo group. Both the differences in relative risk and mortality relative risk between the two groups were not statistically significant. (At that time, these results had not yet been peer-reviewed.)
“We found that it [ivermectin] had no effect whatsoever on our primary outcomes,” Mills said. “In our specific trial, outpatient, we do not see the treatment benefit that a lot of advocates believe should have been” seen, Mills said.