Ivermectin among generic drugs that didn't help COVID-19 patients avoid hospitalization, major study finds - CNET

Ivermectin among generic drugs that didn’t help COVID-19 patients avoid hospitalization, major study finds – CNET

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A new study has found that three generic drugs – fluvoxamine, which is often prescribed to treat depression, the controversial antimalarial ivermectin and the diabetes drug metformin – failed to prevent the type of COVID-19 serious that leads to a visit to the emergency room or hospitalization.

The research, published Wednesday in the New England Journal of Medicine, examined whether any of three drugs benefited 1,323 patients when prescribed in the early days of a COVID-19 infection. Some of the study participants received a combination of metformin and fluvoxamine or metformin and ivermectin, most were vaccinated, and all were overweight. The randomized, placebo-controlled Phase 3 study was conducted from December 2020 to January this year by researchers at the University of Minnesota.

“None of the drugs showed any impact on the primary outcome, which included low oxygen measured on a home oxygen monitor,” said Dr. Carolyn Bramonte, the study’s principal investigator and assistant professor. internal medicine and pediatrics at the University. from the Minnesota Medical School.

Low blood oxygen, or hypoxemia, is a common reason that patients with COVID-19 end up seeking emergency care, being hospitalized, or dying.

Until the Food and Drug Administration clears Pfizer’s PFE,
the antiviral Paxlovid and the MRK from Merck,
Lagevrio at the end of 2021, there was no authorized treatment for people who tested positive for the virus but were not yet sick enough to go to hospital. Repurposed drugs – which are cheap, readily available and have decades of safety data, including in children and pregnant women – have had particular appeal for regulators and clinicians since the early days of the pandemic. .

Each of the three generic drugs has been touted as a possible COVID-19 drug, particularly ivermectin, which has gained a cult following during the pandemic despite well-documented issues with flawed science that in some cases has fraudulently touted the benefits of the drug. Yet, so far, none have been shown in robust clinical trials to actually help treat people with COVID-19.

A long-awaited double-blind, randomized, placebo-controlled study conducted by Duke University School of Medicine and funded by the United States concluded in June that ivermectin did not improve the duration of symptoms in COVID-19 patients. with mild to moderate forms of the disease. The same research found that the drug did not reduce hospitalizations or deaths.

Some of the same University of Minnesota researchers petitioned the FDA last year to clear fluvoxamine as a COVID-19 treatment, based on an earlier set of clinical data. The regulator declined to grant emergency authorization this spring, saying the data did not show the drug’s ability to treat COVID-19.

There is a possible silver lining in the study results, at least for metformin. When researchers looked at the study’s secondary endpoints, they found that metformin reduced emergency room visits, hospitalizations or deaths by 40%, even though the pill did not show an impact on hypoxemia. That said, the researchers say more studies need to be done before clinicians start prescribing metformin to their COVID-19 patients.

“We are really happy that our study adds to the knowledge that we are gaining around this pandemic in this virus,” Bramonte said. “At this point, some doctors may see our results and see metformin as providing easily accessible treatments for some patients. However, as a medical researcher, I see the need for further study to replicate these results as the primary outcome of a study.

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