The antidepressant fluvoxamine could prevent people from becoming seriously ill with COVID-19, slowing down hospitalizations, according to new data.
The results come from the actual use of the drug to treat workers at the Golden Gate Fields horse racing track in Berkeley, California. Among those who chose to take fluvoxamine, none became ill and, after two weeks, their symptoms cleared up. In comparison, 12.5 percent of those who rejected the drug ended up hospitalized. Two became so ill that they were fitted with a ventilator to help them breathe and one died, researchers reported on Feb. 1 in Open Forum Infectious Diseases.
The data need verification of larger ongoing clinical trials. However, some experts say the new findings, along with observational data from cells, animals and humans, suggest that a two-week course of fluvoxamine could be considered, which costs about $ 10 and is already approved by the Food and Drug Administration. United States. patients at high risk for severe COVID-19 symptoms.
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Track doctor David Seftel and David Boulware, an infectious disease medical scientist at the University of Minnesota School of Medicine in Minneapolis, led the real-world test for fluvoxamine after hundreds of workers became infected with the virus around Thanksgiving. Earlier that month, Seftel had heard of fluvoxamine during a presentation by technology entrepreneur Steve Kirsch, whose COVID-19 Early Treatment Fund supports research into existing drugs that could be reused to treat coronavirus infections.
Kirsch shared the results of a fund-backed randomized trial in which none of the 80 newly diagnosed COVID-19 patients assigned to a two-week course of fluvoxamine became seriously ill. In comparison, six of the 72 patients, or 8.3 percent, who took placebo tablets worsened and needed hospitalization, researchers reported in November in the Journal of the American Medical Association.
However, it was not only the results of the trial that fascinated Seftel. “I immediately got into biochemistry,” he says.
The drug’s biochemistry implied that it might be able to regulate cellular responses to stress and infection. Fluvoxamine, which is sold as Luvox, is a selective inhibitor of serotonin reuptake or SSRIs, usually prescribed for obsessive-compulsive disorder. SSRIs increase the levels of the chemical messenger serotonin in the brain. Medications, especially fluvoxamine, also activate a protein called the sigma-1 receptor that prevents the production of chemical messengers that aggravate inflammatory reactions.
In a 2019 study that inspired the randomized trial, mice lacking a sigma-1 receptor died from systemic inflammation known as sepsis, while fluvoxamine treatment protected the animals from deterioration and death. In addition, experiments with laboratory dishes described in science on Dec. 4 showed that knocking down sigma-1 receptor levels in cultured cells reduced rates of infection with SARS-CoV-2, the virus that causes COVID-19. Fluvoxamine also blocks the activation of platelets, important blood components for clotting. This antiplatelet activity, along with mouse and cell data, explain how fluvoxamine can eliminate immune activity out of control and prevent blood clots, both key features of severe COVID-19 (SN: 25/09/20; SN: 02/11/20).
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Seftel shared emerging data on fluvoxamine with 113 infected workers and offered a 14-day course of fluvoxamine (50 milligrams taken twice a day) provided by the circuit at no cost to those who could take the drug safely. The group was predominantly male and Latino, and 30 percent had chronic medical problems such as diabetes or high blood pressure.
Sixty-five people chose to take the drug and 48 refused. The treatment group had a higher proportion of Latinos and tended to be sicker: 62 percent entered the study with symptoms of COVID-19 compared with 42 percent of the group who refused treatment. No one who chose to take the drug suffered serious complications, and after 14 days, none reported persistent symptoms such as anxiety, fatigue, and brain fog. But six of the 48 people who refused fluvoxamine were hospitalized and one died. What’s more, 60 percent still reported experiencing a variety of symptoms, including shortness of breath and muscle and joint pain two weeks after their diagnosis.
The racetrack study adds evidence that there may be a benefit in administering the drug even if it was not a randomized, controlled trial, which many consider the gold standard for clinical evidence. “He didn’t go blind. Excessive, unconscious bias can occur when you know who is receiving treatment or not, "says Jeffrey Klausner, a UCLA infectious disease physician who did not participate in the research. But" it definitely reduces the likelihood that the first study was by chance. ".
Researchers at the University of Washington School of Medicine in St. Louis are testing fluvoxamine in a larger, randomized national trial funded by the Kirsch Fund and other philanthropic sources. Participants receive pills, either fluvoxamine or placebo, at their homes, along with a thermometer, pulse oximeter, and blood pressure monitor. They take the pills for 15 days and record the symptoms on a web-based platform. So far, the trial has registered 168 people, says coin researcher Angela Reiersen, a child psychiatrist. The team expects to collect data from 880 people.
Randomized trials in Korea, Brazil, and Hungary are also investigating fluvoxamine as a possible treatment in patients with mild to moderate COVID-19 disease.
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Doctors usually expect clear answers from large randomized trials to decide how best to treat patients. However, given the scarcity of treatment options and the urgency of the pandemic, Klausner says doctors should consider advising patients on promising treatment options despite limited data awaiting more definitive evidence from ongoing studies.
“I am not yet ready to see fluvoxamine recommended in national treatment guidelines,” he wrote in a Jan. 27 post in the Washington Post. "But I'm prepared to test it with individual patients at higher risk for negative results."
Reiersen agrees. Given the wealth of data from clinical, animal, and clinical studies, "there is reasonable evidence that it is likely to be useful: more for fluvoxamine than (for) virtually anything else (other) than there is for outpatient treatment." of.