Fluvoxamine is given early in the course of the disease, potentially staving off more severe outcomes
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National Post reporter Tom Blackwell wrote about the fluvoxamine findings — now peer-reviewed and published in the Lancet Global Health journal — when they were first posted on a preprint site. Below is his August 16, 2021, story ….
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An inexpensive anti-depressant curbed the number of COVID-19 patients ending up in hospital by 30 per cent, making it a potential breakthrough treatment for a virus that continues to spread widely, a Canadian-led clinical trial is reporting.
If confirmed by more research, the drug, fluvoxamine, would be one of the most effective and convenient to treat the virus outside of pricey new “monoclonal antibodies.” They typically have to be administered in a hospital, as opposed to a pill taken orally at home.
Fluvoxamine is given early in the course of the disease, potentially staving off more severe outcomes and their cost to the health-care system.
The relatively large, randomized controlled study was carried out in Brazil and spearheaded by co-principal investigator Ed Mills and other researchers associated with McMaster University in Ontario. It was part of their larger Together trial that is testing a number of potential drug treatments against COVID.
The researchers looked at the rate of hospitalization among patients with test-confirmed infection. Most of the eight studied drugs, including much-debated candidates such as hydroxychloroquine and ivermectin , showed no detectable benefit.
But the study found that 77 of the 739 subjects who were randomly selected to receive fluvoxamine ended up spending more than six hours in an emergency department or being admitted to hospital, compared to 108 of the 733 who were administered a placebo.A generic and low-cost antidepressant appears able to reduce the risk that COVID-19 will land an infected patient in the hospital, according to a Brazilian study published in the Lancet Global Health journal.
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The trial’s independent data-safety monitoring board, which keeps an eye on results that are blinded to the actual researchers, ordered the trial stopped after seeing the positive numbers, said Mills.
It confirms smaller, earlier studies that had shown promise for the drug — used to treat obsessive-compulsive disorder — and its anti-inflammatory properties.
“This is among the most important findings since the COVID pandemic began,” said Mills, a part-time professor at McMaster. “There is no other treatment for early COVID that has been shown to prevent serious disease progression.”
“You have a Canadian-led study that has the potential to change guidance around the world for a very cheap treatment,” he said. “This is a massive finding of benefit to public health.”
Costing about $4 per 10-day course, fluvoxamine could be especially important in poorer countries with low vaccination rates and that lack the ability to acquire more expensive therapies, he said.
The researchers — including co-principal investigator Dr. Gilmar Reis of Brazil’s Pontificia Universidade Catòlica de Minas Gerais — plan to post a paper outlining their results on a pre-print site and submit it to a journal for publication within days, but so far it has yet to be peer-reviewed.
They did, however, present their findings to a meeting of the National Institutes of Health (NIH) in the U.S. last week and to World Health Organization experts. And the team includes world-renowned clinical trial experts from McMaster, including Dr. Gordon Guyatt, credited with coining the term “evidence-based medicine.”
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Scientists not associated with the trial voiced cautious optimism about the results, while suggesting more research would be helpful before giving the green light for the medicine’s widespread use against COVID.
“This is really the first large trial that shows a benefit for fluvoxamine — or any oral medication,” said Dr. David Boulware, an infectious disease specialist at the University of Minnesota and national co-chair of the NIH’s own trial investigating potential COVID treatments.
“It’s inexpensive, it’s generic and it’s going to be used. So in that sense it’s a world-wide drug.”
Boulware, who was co-author of one of the earlier, small studies of fluvoxamine and COVID, said some of the monocolonal antibody treatments given emergency approval by regulators have greater effectiveness, but their high cost and mode of administration limit how widely they are used.
Dr. Gerald Evans, head of the infectious disease department at Queen’s University’s medical school, said he’d like to see even larger trials conducted in other parts of the world to confirm the findings.
But Evans noted the trial did back up those earlier studies and was headed by respected researchers. He called the findings “impressive.”
“Everything that I’ve seen does suggest it’s an honest, true signal,” he said. “This is the first drug that has shown a consistent benefit for COVID 19, which separates it from others being studied.”
Fluvoxamine is part of the widely used selective serotonin-reuptake inhibitor (SSRI) family of anti-depressants, but was found previously to also have anti-inflammatory properties.
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COVID-19 patients get most severely ill when their immune systems go haywire in response to the infection, causing what’s called a cytokine storm.
Fluvoxamine does not attack the SARS-CoV-2 virus itself, but addresses that immune response.
The idea of using it was first tested by doctors Eric Lenze and Angela Reiersen at Washington University in St. Louis. They published a paper last November involving a total of about 150 subjects randomly assigned to either fluvoxamine or a placebo, suggesting the drug curbed the rate of patients suffering serious clinical deterioration.
An observational “cohort” study published in February , where patients themselves chose whether to take fluvoxamine, found that those who did were much less likely be hospitalized or have symptoms after 14 days.
The Together trial, being carried out in Brazil’s Minas Gerais region, is an adaptive platform trial, where different drugs are added or removed depending on ongoing results.
Fluvoxamine was added to the trial just this January in light of the results of the smaller studies, said Mills.
(Corrected name of Washington University Aug. 16)
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