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News Flash—Fluvoxamine: An Oral Drug for COVID-19 That’s Effective, Safe, and Cheap

“Price is what you pay. Value is what you get.”

- Warren Buffett, American businessman


“Better three hours too soon than a minute too late."

- William Shakespeare


The results of a large randomized clinical trial (RCT) of fluvoxamine (trade name Luvox), an oral antidepressant repurposed for treatment of COVID-19 patients, were published on October 27 in The Lancet Global Health, “Effect of early treatment with fluvoxamine on risk of emergency care and hospitalization among patients with COVID-19: the TOGETHER randomized, platform clinical trial.” In my opinion this drug will be a real game changer in the battle against COVID-19 warranting a special Germ Gems post.

What is Luvox and how does it work in COVID-19. Fluvoxamine (trade name Luvox) was approved by the U.S. Food & Drug Administration (FDA) in 1994 for the treatment of depression and introduced as Luvox in the U.S. It is a selective serotonin reuptake inhibitor (SSRI). It was one of the first such anti-depressants to be launched. (You may be more familiar with a chemically related SSRI, fluoxetine—trade name Prozac.) In 2007, the FDA approved Luvox for the treatment of obsessive-compulsive disorder.


Luvox is also known to have anti-inflammatory properties. In early studies of COVID-19, it was found that a dysregulated immune response to the virus called a “cytokine storm” played a pathogenic role in severe disease. Based on this knowledge, clinical researchers carried out several small trials of Luvox in outpatients with COVID-19. The results of these treatment studies were promising and supported the need for a larger RCT study like the one detailed in The Lancet Global Health.

What did the recent RCT of Luvox show? The TOGETHER RCT of Luvox was carried out in Brazil among unvaccinated, high-risk symptomatic COVID-19 outpatients (average age ~ 50); 741 received Luvox and 756 were randomized to the placebo. As reported on October 27 in the New York Times, the drug (100 mg taken twice a day for 10 days) reduced the overall need for hospitalization or prolonged medical observation by one-third. But among patients who largely followed doctors’ orders, the drug reduced the need for hospitalization by two-thirds and substantially lowered the risk of dying: only one Luvox-treated patient died compared with 12 given placebo. These are astonishing results.


The bottom line. Obviously, there is a need for additional RCTs of Luvox not only to see if these impressive results hold up but also to explore different dosing regimens. And it is important to also know if the benefits of Luvox hold in vaccinated patients as only unvaccinated patients were entered in the Brazil trial. Additionally, down the line studies should be carried out that compare Luvox to molnupiravir, Merck’s new antiviral agent, as well as to other outpatient therapies that are known to be effective or that look promising such as those reviewed in the October 13 Germ Gems post, “Game-Changing Outpatient Treatments of COVID-19.”

Right now, we can all be assured of two things with regard to Luvox. First, it has been used for almost 30 years and has proven to be safe and effective for its intended purposes. Second, it is cheap. A 10-day course of Luvox costs about $4, making it affordable even in low- and middle-income countries.


If the FDA approves Luvox for the treatment of COVID-19, it will be critically important to start treatment with this drug early, that is, as soon as the diagnosis of a COVID-19 infection is confirmed. The readily available rapid in-home COVID-19 diagnostic tests will facilitate this process. If you test positive, it’s time to contact your physician to discuss your treatment options. Hopefully, Luvox will soon be one of them.

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Main Page images courtesy of Shuxian Hu, MD. Dr. Hu is a scientist in the Neuroimmunology Research Laboratory at the University of Minnesota.

 

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