New Coronavirus News from 1 Dec 2022

Ivermectin shown ineffective in treating COVID-19, according to multi-site study including KU Medical Center [University of Kansas Medical Center, 1 Dec 2022]

By Anne Christiansen-Bullers

Results of the study of the antiparasitic medication, once a much-discussed potential treatment for COVID-19, were published in the Journal of the American Medical Association.

Researchers at the University of Kansas Medical Center were part of a multi-site collaboration that found that ivermectin has no measurable effect in improving COVID-19 outcomes.

In an article recently published in the Journal of the American Medical Association (JAMA), the researchers concluded that taking 400 mcg/kg ivermectin for three days, when compared with a placebo, did not significantly improve the chances for a patient with mild to moderate symptoms of COVID-19 to avoid hospitalization.

The use of ivermectin also showed no measurable decrease in the severity of COVID-19 symptoms or the length of time these patients experienced COVID-19 symptoms.

“The most important takeaway from the study is that ivermectin does not help improve outcomes from COVID-19 infection and thus should not be used as a treatment for COVID-19,” said Tiffany Schwasinger-Schmidt, M.D., Ph.D., associate professor of internal medicine at the University of Kansas School of Medicine-Wichita, director of the Center for Clinical Research and site director of the study for the KU Medical Center location in Wichita.
Mario Castro, M.D., MPH, vice chair for clinical and translational research and division director of pulmonary and critical care medicine for KU School of Medicine, provided oversight of the study.

About the study
KU Medical Center was part of a nationwide initiative that allowed research institutions to collaborate on COVID-19 studies in hopes of getting results sooner than any one site could achieve on its own.

This initiative, the Accelerating COVID-19 Therapeutic Interventions and Vaccines Study Group and Investigators, is also known as ACTIV. This study to examine ivermectin, as well as a few other current medications to gauge their effectiveness against COVID-19, goes by the name of ACTIV-6.

The ACTIV-6 study enrolled 1,800 participants. These participants received packages at their residences that contained either a dose of ivermectin or a placebo. Because it was a double-blind study, the participants did not know whether they received ivermectin or not.

Of the initial enrollment, 1,591 participants with confirmed cases of COVID-19 reported receiving their shipment, and follow-up data were collected by 93 separate study sites across the United States.

“This trial was innovative in that it used a remote clinical trial design, allowing people in all areas in the U.S. to enroll in a clinical trial and have the investigational drug shipped directly to their house,” explained Schwasinger-Schmidt. “This is different in that most clinical trials require participants to come to a center to receive study medication.”

The study results
When the participants’ data were analyzed, researchers came up with two results. The first was the median recovery time, or the amount of time it took patients to report having recovered from COVID-19. The second was the number of hospitalizations or deaths within each study group.

Researchers found that the median recovery time for those taking ivermectin was 12 days, and those on the placebo was 13 days. There were 10 hospitalizations or deaths in the ivermectin group and nine in the placebo group. But these differences failed to be statistically significant, leading researchers to their conclusion that “these findings do not support the use of ivermectin in patients with mild to moderate COVID-19.”

What is ivermectin?
Ivermectin is an oral medication initially introduced as an animal de-wormer in 1971 and approved for human use in 1986. Its main purpose (to remove parasites from the body of either animals or humans) means it was initially classified as an “anti-parasitic agent,” according to Schwasinger-Schmidt.

“It kills parasites that cause river blindness and other illnesses and has been used safely in millions of people,” she said.

Ivermectin and COVID-19
Ivermectin entered the American lexicon as a possible treatment for COVID-19 when Pierre Kory, M.D., a pulmonologist and president of Frontline COVID-19 Critical Care Alliance (FLCCC) testified before a U.S. Senate committee hearing in December 2020. Kory called ivermectin a “miracle drug” against COVID-19 and urged the government to issue prescription guidelines for its use in treating the coronavirus.

Prior to Kory’s testimony, Australian researchers in the spring of 2020 had observed that ivermectin killed the coronavirus in a laboratory setting. But a story in The Seattle Times pointed out that the amount used in the lab was much higher than the approved use for humans and could be fatal.

Tests continued throughout the world, however, building that hope that Kory shared with the Senate committee. “Ivermectin had been studied in the laboratory prior to implementation in this trial, and it appeared to decrease replication of the COVID-19 virus through decreasing responses in the inflammatory pathway to the virus,” Castro said.

Ivermectin became an especially hopeful solution for individuals not convinced in the safety or efficacy of the COVID-19 vaccine. But these worldwide studies — including a clinical trial of ivermectin in Brazil called TOGETHER and now the ACTIV-6 trial in the U.S. — have failed to find ivermectin helpful for COVID-19 treatment.

“In clinical trials, it is equally as important to discover which medications don’t work to treat illness as well as medications that do,” Schwasinger-Schmidt said. “This study showed what didn’t work.”