Proof of effectiveness would give doctors
outpatient COVID-19 therapies amid limited antiviral and antibody supplies.
University of Minnesota researchers expect to finish enrollment this week in the nation's first clinical trial of ivermectin to treat COVID-19, and the study's highly anticipated results
could be only a month away.
The COVID-OUT study is reviewing three common drugs, including the antidepressant fluvoxamine and the diabetes treatment metformin, but gained attention for its inclusion of ivermectin. The controversial drug has been championed by opponents of COVID-19 vaccines, despite a warning from the Food and Drug Administration (FDA) that ivermectin is cleared only to treat parasitic infections, head lice and certain skin conditions.
Anti-inflammatory benefits of all three medications prompted the U study, which was delayed by slow enrollment over the summer until the delta and omicron waves of the pandemic emerged. Lead researcher Dr. Carolyn Bramante said the results will provide clinical guidance to doctors who are facing record pandemic cases and to the FDA about whether to authorize the drugs for treatment of COVID-19.
"Sooner would have been better, but I'm really proud of my team," she said. "We will be done very quickly."
Proven outpatient COVID-19 treatments have been limited, and supplies in Minnesota have been scarce. Providers in the state discontinued two types of monoclonal antibody infusions in December because they were ineffective against the omicron variant, and providers had to ration the effective types. New antiviral COVID-19 pills that have received emergency FDA approval are coming in small shipments every other week to Minnesota.
The U trial is enrolling 1,100 patients with COVID-19 to receive fluvoxamine and ivermectin, alone or in combination with metformin, or a nonmedicating placebo for comparison. The study is tracking whether patients taking the drugs for 14 days avoid hospitalization and maintain healthy blood oxygen levels.