Ivermectin did not reduce Covid-19 hospitalizations in largest trial to date

Researchers testing repurposed drugs against Covid-19 found that ivermectin did not reduce hospital admissions, in the largest trial to date of the antiparasitic’s effect on the disease that caused it the pandemic.

Ivermectin has received a lot of attention as a potential treatment for Covid-19, including from celebrities such as podcast host Joe Rogan. Most of the evidence has shown to be ineffective against Covid-19 or relied on low-quality data, infectious disease researchers have said. Public health authorities and researchers have said for months that the drug has shown no benefit in treating the disease. Taking large doses of the drug is dangerous, the Food and Drug Administration said.

The latest trial, involving nearly 1,400 Covid-19 patients at risk of severe disease, is the largest to show that those who received ivermectin as treatment fared no better than those who did. received a placebo.

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“There was no evidence that ivermectin was clinically useful,” said Edward Mills, one of the study’s principal investigators and a professor of health sciences at Canada’s McMaster University in Hamilton, Ont. Dr. Mills plans to present the findings, which have been accepted for publication in a major peer-reviewed medical journal, on Friday at a public forum sponsored by the National Institutes of Health.

Dr Mills and his colleagues examined 1,358 adults who visited one of 12 clinics in the Minas Gerais region of Brazil with symptoms of Covid-19. The patients all had a positive rapid test for SARS-CoV-2 and were at risk of having a severe case for reasons including a history of diabetes, hypertension, cardiovascular disease or lung disease.

Poster with the phrase “We have ivermectin” in a pharmacy in Ceilândia, Brazil.


Photo:

Ricardo Jayme/AGIF/Associated Press

The researchers prescribed half of the patients a course of ivermectin pills for three days. The other half received a placebo. They tracked whether patients were hospitalized within 28 days. Researchers also looked at whether patients on ivermectin cleared the virus from their bodies faster than those given a placebo, whether their symptoms cleared sooner, whether they were in hospital or on ventilators for less time, and there was a difference in death. rates for both groups.

To ensure they were thorough, the researchers analyzed the data in three different ways. They looked at data from all patients; then analyzed the data of patients who received ivermectin or a placebo 24 hours before their hospitalization; and in a third review, looked at data from patients who said they strictly adhered to their dosing regimen. In each scenario, they found that ivermectin did not improve patient outcomes.

“This is the first large prospective study that should really help put ivermectin to rest and give no credibility to its use for Covid-19,” said Peter Hotez, dean of the National School of Tropical Medicine. from Baylor College of Medicine. , who reviewed the results.

Ivermectin is mainly used to treat patients with certain parasitic diseases. It has antiviral properties, but has not been approved by the FDA to treat viral infections.

Given its antiviral prospects, scientists early in the pandemic believed it could be a candidate for the treatment of Covid-19. In June 2020, a group of Australian researchers published a paper showing that large amounts of ivermectin could stop coronavirus replication in cell cultures. But there was a catch: To achieve this effect, a person had to take up to 100 times more ivermectin than the dose approved for use in humans.

Some ivermectin studies published in journals or on preprint servers prior to peer review showed no benefit, or worsening of Covid-19 symptoms, after using ivermectin. Some have shown some benefits, such as faster time to resolution of symptoms, reduced inflammation, faster viral clearance, and lower death rates.

Ivermectin capsules, seen last year in the Philippines, where the drug was distributed in some places despite a lack of evidence to show it prevents or cures Covid-19.


Photo:

rolex dela pena/Shutterstock

But most of the studies showing positive effects had significant limitations such as small sample sizes or ill-defined results, according to the NIH. Several studies of ivermectin have been withdrawn from publication, including a randomized controlled trial involving 100 patients in Lebanon that was retracted by Virus magazine due to problems with statistical analysis, according to the newspaper. Researchers from the NIH and the University of Oxford are also conducting large trials on the effectiveness of ivermectin, although the results have not been published.

Dr Mills said ivermectin could improve outcomes in Covid-19 patients who are fighting certain parasitic diseases at the same time. But based on his team’s findings, he said, the drug does not appear to have any effect on Covid-19 itself.

Dr Mills and his colleagues are also studying other drugs that could be repurposed to fight Covid-19. Such drugs could be useful because their side effects are well known and they may be cheaper to deploy in poor countries than drugs like molnupiravir from Merck & Co. and Ridgeback Biotherapeutics LP or Pfizer. Inc.

it’s Paxlovid.

New studies offer clues to who might be more susceptible to long Covid, a term for lingering symptoms of Covid-19. WSJ breaks down the science of long Covid and the state of treatment. Illustration: Jacob Reynolds for the Wall Street Journal

Merck said it has taken steps to make molnupiravir available in low- and middle-income countries, including allocating three million courses to distribute through aid groups and licensing generic manufacturers. Pfizer said it was working to expand its supply chain and license production of Paxlovid through a United Nations program.

Dr Mills and his collaborators looked at 11 redirected treatments for Covid-19, at least one of which showed promise: fluvoxamine, which is commonly used to treat obsessive-compulsive disorder and depression. They published the research in the Lancet Global Health in October, showing that Covid-19 patients who received fluvoxamine were less likely to require hospitalization than those who did not.

Researchers are studying the effect in Covid-19 patients of the combination of fluvoxamine and an inhaled steroid, budesonide, as well as a drug called peginterferon lambda, which is used to treat chronic viral hepatitis.

Write to Sarah Toy at [email protected]

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