The antidepressant fluvoxamine appears to prevent COVID-19 infections from getting worse and may help keep patients out of the hospital, suggests a trial based on research from the University of Washington School of Medicine.
The clinical trial, conducted by Washington University School of Medicine in St. Louis, compared fluvoxamine to a placebo in 152 adult outpatients infected with the coronavirus. None of the 80 participants who received fluvoxamine became seriously ill after 15 days, while six patients did. Of those six, four were hospitalized, for periods ranging from 4 to 21 days. Only one was connected to a ventilator for 10 days.
While the study size was small, the researchers say the results are statistically significant and fluvoxamine warrants further study as a COVID-19 treatment. A larger test is planned to launch in the coming weeks.
“The patients who took fluvoxamine did not develop severe breathing difficulties, nor did they require hospitalization for problems with lung function,” said Eric J. Lenze, MD, of the University of Washington School of Medicine. “Most of the investigational treatments for COVID-19 have been aimed at the sickest patients, but it is also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or have to go to the hospital. Our study suggests that fluvoxamine can help fill that niche, “Lenze added.
Fluvoxamine and COVID-19
Researchers at the University of Washington launched the randomized, double-blind trial based on a discovery by Alban Gaultier, PhD, of UVA, and former graduate student Dorian A Rosen, PhD. Gaultier and Rosen discovered last year that fluvoxamine can stop the deadly inflammation known as sepsis, in which the immune response spirals out of control. The drug reduced the production of cytokines, which have been linked to life-threatening “cytokine storms” believed to occur in severe cases of COVID-19.
That connection led the University of Washington team to investigate the possibility that fluvoxamine might have a protective effect for COVID-19 patients. Perhaps, they thought, the drug could help prevent immune system overreactions caused by this strange new coronavirus. And his work suggests yes.
“Because elevated levels of cytokines have been associated with the severity of COVID-19, testing fluvoxamine in a clinical trial made perfect sense to us,” said Gaultier, from the Department of Neuroscience at UVA and its Center for Brain Immunology. and Glia (BIG). “We are not yet clear about the mode of action of fluvoxamine against SARS-CoV-2, but research is ongoing to find the answer.”
The University of Washington team noted that recent research has raised questions about whether cytokines actually play a role in deaths from COVID-19. Otherwise fluvoxamine may be having beneficial effects through some other mechanism not yet understood, according to the researchers’ approach.
“There are several ways this drug could work to help COVID-19 patients, but we think it most likely interacts with the sigma-1 receptor to reduce the production of inflammatory molecules,” said Dr. Angela M Reiersen of the University of Washington. “Previous research has shown that fluvoxamine can reduce inflammation in animal models of sepsis, and it may be doing something similar in our patients.”
The researchers emphasized that their research had several limitations. In addition to its small size, the trial was hampered by other factors, including that 20% of participants stopped answering surveys during the 15-day trial.
Because of these limitations, the researchers say the trial results should not be treated as a measure of fluvoxamine’s effectiveness against COVID-19, but rather as an encouraging indicator that the drug deserves further testing.
“If a larger clinical trial (phase III) confirms the results, fluvoxamine would be a perfect treatment for newly diagnosed COVID patients,” Gaultier said. “Fluvoxamine is not an experimental drug, it is cheap and safe, and it could be available as a first line of defense to relieve hospitals overwhelmed by the COVID health crisis.”
The researchers have published the results of their trials in the Journal of the American Medical Association. The clinical trial was funded by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the COVID-19 Early Treatment Fund. The University of Washington Center for Brain Research in Mood Disorders, the Bantly Foundation, and grant UL1TR002345 from the National Institutes of Health provided additional support. (I)