A new study found that three generic drugs — fluvoxamine, commonly prescribed to treat depression, the controversial antimalarial drug ivermectin and the diabetes pill metformin — failed to prevent the kind of severe COVID-19 that leads to emergency room visits or hospitalization.
The study, published Wednesday in The New England Journal of Medicine, examined whether one of the three drugs benefited 1,323 patients when prescribed in the early days of a COVID-19 infection. Some of the study participants were given 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 by researchers at the University of Minnesota from December 2020 and January this year.
“None of the drugs had any impact on the primary outcome, including experiencing low oxygen as measured on a home oxygen monitor,” says Dr. Carolyn Bramonte, the study’s principal investigator and an assistant professor of internal medicine and pediatrics at the University of Minnesota Medical School.
Low blood oxygen or hypoxemia is a common reason why COVID-19 patients end up seeking emergency care, being hospitalized, or dying.
Until the Food and Drug Administration approves Pfizer’s PFE,
antiviral Paxlovid and Merck’s MRK,
In Lagevrio, there were no authorized treatments at the end of 2021 for people who had tested positive for the virus but were not yet sick enough to go to hospital. Recycled drugs — which are inexpensive, readily available, and contain decades of safety data, including in children and pregnant women — have been of particular appeal to regulators and clinicians alike since the onset of the pandemic.
Each of the three generic drugs has been held up as a potential COVID-19 drug, most notably ivermectin, which gained cult status over the course of the pandemic, despite well-documented issues with the flawed science that in some cases fraudulently promotes the benefits of announced the drug. But so far, none have been shown in robust clinical trials to actually help treat people with COVID-19.
A highly anticipated double-blind, randomized, placebo-controlled study conducted by Duke University School of Medicine and funded by the US concluded in June that ivermectin did not improve symptom duration in COVID-19 patients with mild to moderate forms of the disease. The same study found that the drug did not reduce hospitalizations or death.
Some of the same University of Minnesota researchers last year asked the FDA to approve fluvoxamine as a COVID-19 treatment, based on a previous set of clinical data. The regulator declined to grant emergency clearance this spring, saying the data did not show the drug can treat COVID-19.
There is one possible bright spot in the study’s findings, at least for metformin. When the researchers looked at the secondary endpoints of the study, they found that metformin reduced ER visits, hospitalization, or death by 40%, although the pill does not affect hypoxemia. That said, the researchers say additional studies should be conducted before clinicians begin prescribing metformin to their COVID-19 patients.
“We are very pleased that our study contributes to the knowledge we are gaining around this pandemic in this virus,” Bramonte said. “Right now, there may be physicians who see our results and see that metformin provides easily accessible treatments for certain patients. However, as a physician-researcher, I see a need for further research to replicate these results as the primary outcome of a trial.” .
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