The New England Journal of Medicine trial showed fluvoxamine and metformin also had no impact in stopping severe disease
Primary outcome
A new study found three generic drugs — fluvoxamine, which is often prescribed to treat depression, the controversial antimalarial ivermectin, and the diabetes pill metformin — failed to prevent the kind of severe COVID-19 that leads to an emergency room visit or hospitalization.
The research, published Wednesday in The New England Journal of Medicine, examined whether any of the three medications benefited 1,323 patients when prescribed in the early days of a COVID-19 infection.
The randomized, placebo-controlled, Phase 3 study was conducted from December 2020 to January of this year by researchers at the University of Minnesota.
“None of the medications showed any impact on the primary outcome, which included experiencing low oxygen as measured on a home oxygen monitor,” said Dr. Carolyn Bramonte, principal investigator of the study and an assistant professor of internal medicine and paediatrics at the University of Minnesota Medical School.
Having low blood oxygen levels, or hypoxemia is a common reason why COVID-19 patients end up seeking care in an ER, being hospitalized, or dying.
No authorized treatments
Until the Food and Drug Administration authorized Pfizer’s PFE, +1.17% antiviral Paxlovid and Merck’s MRK, +0.74% Lagevrio in late 2021, there were no authorized treatments for people who had tested positive for the virus but were not yet sick enough to go to the hospital.
Repurposed drugs — which are cheap, readily available, and have decades of safety data, including among children and pregnant women — have held a particular appeal for regulators and clinicians alike since the pandemic’s earliest days.
Each of the three generic medications has been held up as a possible COVID-19 drug, particularly ivermectin, which gained a cult following over the course of the pandemic despite well-documented issues with the flawed science that in some cases fraudulently touted the drug’s benefits.
Yet none so far have demonstrated in robust clinical trials that they 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 U.S. concluded in June that ivermectin did not improve symptom duration among COVID-19 patients with mild-to-moderate forms of the disease.
Bright spot
The same research found that the drug did not reduce hospitalizations or death.
Some of the same University of Minnesota researchers last year asked the FDA to authorize fluvoxamine as a COVID-19 treatment, based on an earlier set of clinical data.
There is one possible bright spot in the study’s findings, at least for metformin.
That said, the researchers say additional studies need to be conducted before clinicians begin prescribing metformin to their COVID-19 patients.
“However, as a physician-researcher, I see there’s a need for further study to replicate these results as the primary outcome of a study.”
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Source: Market Watch
