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Researchers in University of Washington School of Medicine in St. Louis published the results of a clinical trial evaluating an antidepressant, fluvoxamine, for the early treatment of COVID-19. The study was published in JAMA, Journal of the American Medical Association, and was funded by the COVID-19 Early Treatment Fund (CETF).
Fluvoxamine, which is a generic but is sometimes sold under the brand name Luvox, is a member of the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Other medications in this class include Prozac (fluoxetine), Zoloft (sertraline), and Paxil (paroxetine). Fluvoxamine is used to treat social anxiety disorder or obsessive-compulsive disorders.
The trial evaluated whether taking fluvoxamine within seven days of the first symptoms of COVID-19 can decrease the risk of respiratory deterioration. The study showed that the drug was effective: none of the 80 patients who received the drug met the criteria for respiratory impairment compared to the 8.3% rate in the 72 patients in the placebo cohort.
“The results of the fluvoxamine trial are encouraging and warrant further evaluation in a larger study,” said Carolyn Machamer, professor of cell biology at Johns Hopkins School of Medicine and a member of the CETF scientific advisory board. “Treatment is desperately needed that can prevent lung problems in people with mild symptoms of COVID-19.”
They chose to investigate fluvoxamine because it has strong anti-inflammatory activity. The research team, led by Eric Lenze, director of the Healthy Mind Laboratory at Washington University School of Medicine in St. Louis, thought the anti-inflammatory properties could prevent cytokine storms, the massive overactive immune response seen in severe cases of COVID-19. .
“This placebo-controlled study indicates that fluvoxamine can prevent serious respiratory problems in people with mild COVID-19 illness, and is the first in this patient population to be published in a peer-reviewed journal,” Lenze said. “There are promising findings and we hope to conduct a much larger study in the coming weeks to further evaluate the effectiveness of fluvoxamine.”
The 152 trial participants were 18 years of age or older and had been diagnosed with mild COVID-19. They all lived in Missouri or Illinois. They were randomized 1: 1 to receive fluvoxamine or placebo. There was no face-to-face contact between the participants and the doctors; all trial materials, including the drug, were delivered to patients’ homes.
Of the 80 participants who received fluvoxamine, none reached the end point of clinical deterioration, which was defined as an oxygen saturation of 92% or less along with shortness of breath or hospitalization for pneumonia. Of the 72 people who received the placebo, six experienced respiratory impairment.
“We now have evidence that a cheap, safe and readily available pill can reduce COVID-19 deterioration and hospitalization,” said Steve Kirsch, founder of CETF. “This trial validates what we have already learned from multiple scientific studies, the greater the sigma-1 activation, the greater the protection.”
Coronavirus replication happens in a modified membranous compartment derived from the endoplasmic reticulum (ER). The sigma-1 receptor is bound to the ER membrane and acts as an upstream modulator of ER stress. As such, researchers have suspected that drugs that activate sigma-1 could be used to treat COVID-19.
The study authors note that it is limited by the small sample size and the short duration of follow-up. To really determine if fluvoxamine is effective, larger randomized trials with ‘more definitive outcomes’ will be needed.
The study confirms a large multicenter observational study conducted in France that showed that SSRI drugs significantly reduced the risk that COVID-19 patients would require a ventilator or die from COVID-19. The French study suggested that SSRIs with the highest sigma-1 receptor activation had the greatest benefit.
