Preliminary findings released Tuesday for a U.S.-based clinical trial of anti-parasite drug ivermectin found that the mortality rate for coronavirus patients fell 40%, according to the Medrxiv.org site.
The ivermectin study -- it began in March as part of a larger Australian-led clinical study -- focused on 280 patients, 173 of whom were treated with the drug at four Broward County, Florida, hospitals.
The research team was led by Dr. Jean-Jacques Rajter, a Broward Health Medical Center physician, and his wife, Juliana Cepelowicz Rajter.
The findings reported in Medrxiv, “ICON (Ivermectin in COVID-19) Study: Use of Ivermectin Is Associated With Lower Mortality in Hospitalized Patients With COVID-19,” said that patients who took part in the trial were given a single dose of the anti-parasitic medication, and some received a second dose a week later.
The dose given the COVID-19 patients was the same as the FDA-approved dose used to treat patients with intestinal parasites.
According to Medrxiv.org, the Broward study found that overall mortality among seriously ill COVID-19 patients treated with the drug was 15%. Mortality among patients in a similar disease state who did not receive ivermectin was 25%.
That would equate to a 40% drop in mortality, a statistically significant difference.
“It’s amazing and could literally pull people back from critical COVID-19 illness,” according to board certified emergency medicine physician Dr. Peter Hibberd, M.D.
In an interview Tuesday, Hibberd hailed the results as a “major breakthrough in COVID-19 management.”
If reviewed successfully, Ivermectin could become the first COVID-19 therapy shown to reduce mortality risk in seriously ill patients in a clinical trial.
A previous therapeutic medication, remdesivir, has already won FDA emergency use authorization. Trials showed remdesivir shortened patients’ hospital stays, but did not show a statistically significant improvement in reducing overall mortality, according to the National Institutes of Health.
“Even if it was judged to need a second dose in seven days,” Hibberd said, “it remains a breakthrough in COVID-19 management.”
Medical experts aren’t sure yet precisely how the drug counters COVID-19. Some suspect it could be blocking a protein that the virus requires in order to reproduce.
Perhaps the study’s most impressive finding: The effect the drug had on 75 sick COVID-19 patients who were suffering from “severe pulmonary disease” – a very high-risk group.
Of patients in that group who did not receive ivermectin, 81% died. Yet the mortality rate for patients with severe pulmonary disease who did receive ivermectin was 39 percent.
In other words, for the most severely ill patients with severe pulmonary disease, the use of ivermectin improved the odds of survival by just over 50%.
As news of ivermectin -- which is used globally to treat scabies, lice and other parasitic diseases -- has spread on the internet, the FDA has warned patients against trying to treat themselves with it.
The FDA on May 1 posted the following advisory: “While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19.” Ivermectin is generally considered safe, however, the FDA warned consumers to never use any form of the drug intended for use by animals.
Hibberd said that once the study is peer-reviewed, he would like to see the FDA grant emergency-use authorization for ivermectin as a coronavirus treatment – to be used under expert medical supervision -- as soon as possible.
When used as prescribed, he said, ivermectin has a very strong safety record.
“This drug has been used for over 30 years by millions of people around the world, and has a marked safety base,” he told Newsmax. “We understand fully its side effects, and the effect of a single dose in such a critically diseased state cannot be ignored.”
Hibberd tells Newsmax that several major U.S. medical centers already list ivermectin as a COVID-19 treatment. It is also reportedly being used to fight the virus in Bolivia, Peru, India, and other nations.
Over a dozen clinical trials of the drug are also reportedly underway in Egypt, Iraq, Argentina, Brazil, Mexico and Australia.
Ivermectin first emerged as a possible coronavirus therapeutic when a study by researchers from Royal Melbourne University and Monash University in Victoria, Australia showed the drug wiped out the virus in a test tube.
Noting patients who received the drug in the Broward County study were already quite ill, Hibberd suggested that giving ivermectin to patients earlier in the disease cycle could be even more beneficial, and might even help them avoid hospitalization altogether.
“That’s why the results were so surprising,” he told Newsmax, “because these people already had damage in their lungs with a rapidly downhill progression.”
“Some of these patients were in extreme distress and rapidly going downhill,” he added, “and their clinical course stabilized with 24 to 48 hours.”
Some patients went home three to four days after receiving treatment, he said.
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