The authors of a study that found a statistically significant difference in recovery times for people who were treated for COVID-19 with ivermectin say that it does not meet the threshold for clinical relevance.
People who tested positive for COVID-19 and took ivermectin as a treatment recovered faster than a comparison group, a new study found.
The time to self-reported recovery was a median of two days faster among the ivermectin recipients, according to the large UK study.
Although the quicker recovery period was statistically significant, the authors said the difference was not enough to support the use of ivermectin as treatment.
Other researchers, however, say that the clinical threshold was arbitrary and that the study write-up downplayed the positive impacts of ivermectin as a treatment which was shown in the results.
The study found that people who received ivermectin were also less likely to be hospitalized or die, with 1.6 percent of ivermectin recipients being hospitalized or dying versus 4 percent of the comparison group, which received typical care, which in the UK is largely focused on managing symptoms.
Ivermectin recipients also enjoyed a reduction of severe symptoms and sustained recovery, according to the study.
Researchers Say Findings Don’t Support Using Ivermectin
The authors, including Christopher Butler, a University of Oxford professor and joint chief investigator of the trial, downplayed the positive findings in part because the hazard ratio of 1.14 was lower than what authors pre-specified as a meaningful ratio, or 1.2. Hazard ratios are a way to determine whether a treatment is beneficial.The authors also focused on the lack of differences in the number of days participants felt sick in the previous two weeks, impact on work, and likelihood of using the health care system at 3, 6, and 12 months following treatment.
“Overall, these findings, while evidencing a small benefit in symptom duration, do not support the use of ivermectin as treatment for COVID-19 in the community among a largely vaccinated population at the dose and duration we used,” the authors said.
Funding for the research came from the UK government.
Conflicts of interest included one researcher receiving grants from pharmaceutical companies, including AstraZeneca, and other authors receiving grants from the University of Oxford.
The trial, known as PRINCIPLE, was touted by investigators as “the world’s largest clinical trial of possible COVID-19 treatments for recovery at home and in other non-hospital settings.”
“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,” Dr. Christopher Butler, a University of Oxford professor and joint chief investigator of the trial, said when it was announced ivermectin would be assessed. “By including ivermectin in a large-scale trial like PRINCIPLE, we hope to generate robust evidence to determine how effective the treatment is against COVID-19, and whether there are benefits or harms associated with its use.”
Doctors Weigh In
Dr. Pierre Kory, co-president of Front-Line COVID-19 Critical Care Alliance, who was not involved in the trial, said that the authors wrongly downplayed how ivermectin improved recovery from COVID-19.Dr. Kory is a Pulmonary and Critical Care Specialist who has been dedicated to treating COVID patients since the year 2020. In the 2024 FLCCC meeting, he reported that among the patients he treated with ivermectin, 70 percent improved with no significant side effects.
He said the authors undertook “statistical chicanery” by coming up with the pre-specified hazard ratio (HR), noting that no such level was used in other parts of the PRINCIPLE trial.
“A hazard ratio does not need a pre-specified level. If the HR is > 1.0, and it is statistically significant, it is a robust finding,” he said.
The positive findings should also be interpreted in the context of recipients only receiving one dose per day across three days and being directed not to eat food before ivermectin, Dr. Kory said.
Dr. Butler did not respond to a request for comment.
Dr. David Boulware, another American doctor, who helped run that trial, argued on X that the faster recovery recorded in the UK trial was similar to the quicker recovery reported in an open-label trial of molnupiravir, an antiviral sometimes used to treat COVID-19.
“Molnupiravir also had a 2 day faster improvement in symptoms over ‘usual care’ yet no benefit existed in double-blind trial,” Dr. Boulware said on X. “Placebo effect influences self-reported symptoms.”
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