Clinical Trials Arena reports that the University has added ivermectin to the Platform Randomized Trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE) study for the treatment of COVID-19.
PRINCIPLE is a large clinical trial designed to assess potential COVID-19 therapies for non-hospitalized patients, including at-home recovery, who are at higher risk of progressing to serious illness.
“Ivermectin is readily available globally, has been in wide use for many other infectious conditions so it’s a well-known medicine with a good safety profile, and because of the early promising results in some studies it is already being widely used to treat COVID-19 in several countries.” PRINCIPLE trial joint chief investigator professor Chris Butler said.
Participants in the study will be randomly assigned a three-day course of ivermectin treatment. They will be followed up for 28 days and will be compared with trialists who receive the usual standard of NHS care only.
The drug, which is known to exhibit antiviral properties, reduced SARS-CoV-2 replication in laboratory studies.
In small pilot studies, results were varied, with some studies showing no effect and others reporting that ivermectin has a potential benefit, in terms of reducing viral load and the duration of symptoms in some patients with mild cases of COVID-19.
However, the lack of evidence from large-scale, randomized controlled trials has made it impossible to say with confidence that the drug is effective in treating the coronavirus.
While the World Health Organization, and European and U.S. regulators have recommended against using ivermectin in COVID-19 patients, it is being used to treat the illness in some countries, including India. Peru, Bolivia and Colombia are also administering ivermectin to patients.
In April, The Gauteng High Court in South Africa allowed doctors to legally prescribe small batches of the custom-made medicine containing ivermectin for the treatment of specific patients with COVID-19.