Antidepressant for COVID-19 Reduces Hospitalization Risk, a New Study Finds

The drug fluvoxamine may help dial back the body's immune response to COVID-19—which can actually be a good thing.

Vaccinating the public against COVID-19 has been a priority since the first shots came online last December. But at the same time, scientists have continued their quest to identify potential treatments for people who get infected.

One of them, the generic drug fluvoxamine, has shown significant potential. Developed 40 years ago as an antidepressant, fluvoxamine—sometimes known as Luvox—has been used mainly to treat obsessive-compulsive disorder (OCD), per the National Alliance on Mental Illness (NAMI). Recently, researchers have been taking a closer look at how the medication could be an important treatment to prevent patients who test positive for COVID-19 from getting seriously ill with the infection.

And now, in the largest randomized trial to date, researchers suggest it might have a role to play for people with early-diagnosed, symptomatic COVID-19.

What the new research tells us about treating early COVID-19 with fluvoxamine

Researchers from Canada, the US, and Brazil conducted the latest study, reported in the Lancet Global Health on October 27. It's part of a larger trial designed to investigate the potential of repurposing existing drugs against COVID-19.

Nearly 1,500 largely unvaccinated Brazilian adults with symptomatic COVID-19 and underlying health issues, such as diabetes and heart disease, were enrolled in the study and treated in one of 11 outpatient clinics. Because of their health status, they were all considered at high risk of developing severe COVID. Half of the study participants were treated with fluvoxamine, while the other half received a placebo, and patients were observed for 28 days after treatment.

Of the people who took 100 milligrams of fluvoxamine twice daily for 10 days, roughly 11% needed an "extended" stay (meaning more than six hours) in an emergency care setting or required hospitalization. That compares with nearly 16% of those taking the sham treatment.

The bottom line: the treatment was associated with a 5% reduction in the "absolute" risk of hospitalization or prolonged emergency care. There was a 30% reduction in the "relative" risk of hospitalization among those receiving fluvoxamine compared to people taking the placebo. In addition, there was one death in the fluvoxamine group compared to 12 in the placebo group, per a Lancet news release.

"Fluvoxamine is, so far, the only treatment that if administered early can prevent COVID-19 from becoming a life-threatening illness," Edward Mills, PhD, of McMaster University in Ontario, Canada, and one of the coauthors, said in a statement.

However, the researchers concluded that more research is needed. It's unclear, for example, whether fluvoxamine would prove as beneficial in a vaccinated population.

What prior research on fluvoxamine has revealed

In an interview with 60 Minutes that aired in March, Angela Reiersen, MD, associate professor of psychiatry at Washington University in St. Louis, who is one of the investigators in the fluvoxamine trials, explained that she first got the idea that the drug could potentially treat COVID-19 after seeing research that fluvoxamine prevented sepsis in mice.

"I thought, well, I wonder if we could use fluvoxamine to treat COVID and prevent that clinical deterioration," Dr. Reiersen told 60 Minutes.

Dr. Reiersen is coauthor of a November 2020 study published in the Journal of the American Medical Association (JAMA) regarding the use of fluvoxamine in COVID-19 patients. She and her colleagues—including Eric Lenze, MD, a fellow psychiatrist at Washington University who also specializes in finding new uses for drugs that are already approved by the Food and Drug Administration (FDA)—went on to conduct the small randomized clinical trial on fluvoxamine and COVID-19 patients.

The results of that JAMA study found that participants with symptomatic COVID-19 who were treated with fluvoxamine "had a lower likelihood of clinical deterioriation" than those who were given a placebo. "The results were really pretty incredible," Dr. Lenze told 60 Minutes Correspondent Sharyn Alfonsi. "Out of the 80 people who received fluvoxamine, none, zero of them deteriorated versus 8% of the people who got [the] placebo."

Of course, since the study was only preliminary, researchers declared that more research was needed to determine "clinical efficacy" of the drug in COVID-19 patients. But that research sparked even more research on fluvoxamine's role in preventing serious disease in those with COVID-19 infections.

David Seftel, MD, a physician in Berkeley, California, opted to offer a 15-day prescription to his own COVID-19 patients, who fell victim to an outbreak in the Golden Gate Fields race track community. (FYI: His decision to use a prescription drug off-label is an accepted medical practice, provided the patient consents. "Off-label" simply means it hasn't been approved by the FDA for that particular condition.)

The results of Dr. Seftel's real world study, which were published in Open Forum Infectious Diseases, showed that, of 65 of those patients who chose to take fluvoxamine, none were hospitalized, while of the 48 who declined the prescription, 12.5% ended up hospitalized, and one died.

How does fluvoxamine work against COVID-19?

Experts believe fluvoxamine has shown to be effective against COVID-19 due to the medication's effects on the body's inflammatory response—specifically by tamping down that response in those with active COVID-19 infections.

Normally, when the body is trying to fight off an invader like SARS-CoV-2 (the virus that causes COVID-19), it releases cytokines, or biological chemicals that stimulate cell pathways and allow for communication between cells. Those cytokines signal to the body's immune system that it needs to start doing its job. In some cases, though, the the outpouring of cytokines becomes accelerated—known as a cytokine storm—creating high levels of inflammation in the body. "Normally, cytokines are meant to be helpful to us in moderation," Carl Fichtenbaum, MD, professor in the division of infectious diseases at the University of Cincinnati College of Medicine, previously told Health, "but when a certain pathway is engaged [too much] the immune system starts causing damage to the patient."

This is where researchers think fluvoxamine comes into play. Though the drug typically works by increasing the amount of serotonin in the body, it also binds to and activates sigma-1 receptors, which may help reduce cytokine production in the body, according to a research article in Science Translational Medicine (this one, looking at patients with sepsis), and ultimately decrease the sometimes deadly inflammation that can occur in COVID-19 patients.

When asked if the positive results could have been a fluke, Dr. Seftel said, "I don't believe so. You cannot influence a virus that is as wily and as wicked as COVID with a fluke."

What role might fluvoxamine play in the treatment of COVID-19?

Francis Collins, MD, PhD, the director of the National Institutes of Health (NIH), told 60 Minutes that "fluvoxamine could certainly be something you wanna put in the tool chest [because] it looks as if it has the promise to reduce the likelihood of severe illness."

And based on results of the new trial, there's hope that this pill, costing only $4 per 10-day course, might make a difference. But obstacles remain. The authors note that fluvoxamine is not on the World Health Organization's Essential Medicines List—medicines considered safe and effective for meeting public health needs.

"If WHO recommends this, you will see it widely taken up," Mills, one of the coauthors, told the Associated Press.

Although the vaccine rollout is greatly reducing the number of people who get seriously ill and are hospitalized with COVID-19, no vaccine offers 100% protection, and new mutations of the virus are appearing all the time. So it's still important to find new treatments for the illness. With more research, we'll have a clearer idea of the part fluvoxamine may play.

The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.

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