A peer-reviewed study in which researchers concluded that ivermectin treatment during early COVID-19 “did not prevent” severe disease in high-risk patients has been criticized by an alliance of doctors for being “misleading.”
In the open-label randomized clinical trial, also referred to as the “The I-TECH Randomized Clinical Trial,” published in the JAMA Internal Medicine journal on Feb. 18, researchers said their findings “do not support the use of ivermectin for patients with COVID-19.”
The study involved results from 490 patients with mild to moderate COVID-19 in Malaysia. Participants were aged 50 and over, with at least one documented comorbidity. People who did not develop symptoms or who had severe COVID-19 were not included in the trial.
The trial was conducted in 20 hospitals and a COVID-19 quarantine center in the country between May 31 and Oct. 25, 2021. Of the group, 249 participants received standard care, while 241 received a course of oral ivermectin over five days in addition to standard care.
Researchers said they found that 21.6 percent of patients in the ivermectin group and 17.3 percent in the standard care group progressed to “severe disease.”
They wrote that there were no statistically significant differences between the two cohorts in how many needed mechanical ventilation, had to be admitted to intensive care unit (ICU), or died within 28 days after having been admitted to the hospital.
Ivermectin is a generic medicine developed in the 1970s and is now widely used against roundworm parasites to treat river blindness and elephantiasis, as well as to treat scabies, lice, and rosacea in humans. William Campbell and Satoshi Omura in 2015 won the Nobel Prize in Physiology or Medicine for the drug’s discovery and applications.
Ivermectin has been praised by some doctors as a life-saving early treatment for COVID-19. At least two groups, the Front Line COVID-19 Critical Care Alliance (FLCCC) and the British Ivermectin Recommendation Development Group (BIRD), have been advocating for the off-label use of ivermectin to treat COVID-19 in its early stages.
The World Health Organization features ivermectin on its List of Essential Medicines. It is also approved as an antiparasitic agent by the U.S. Food and Drug Administration (FDA).
However, the FDA has not approved the drug to treat or prevent COVID-19 in humans. According to the FDA, side effects of ivermectin include skin rash, nausea, and vomiting.
The American Medical Association, the American Pharmacists Association, and the American Society of Health-System Pharmacists, said in a joint statement in September 2021 they were against its use to treat COVID-19 outside of a clinical trial.
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