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Encouraging updates arise from COVID-19 fluvoxamine trial sparked by U.Va. neuroscience research

Despite some drawbacks, the first phases of the research trial present encouraging results in the study of fluvoxamine’s effectiveness against COVID-19

<p>University neuroscientist Alban Gaultier explained that one of the possible benefits of Fluvoxamine, if it successfully goes through phase three, would be how familiar and affordable it would be for hospitals.&nbsp;</p>

University neuroscientist Alban Gaultier explained that one of the possible benefits of Fluvoxamine, if it successfully goes through phase three, would be how familiar and affordable it would be for hospitals. 

The antidepressant Fluvoxamine shows positive signs as a COVID-19 therapeutic in an update from a Washington University School of Medicine in St. Louis research trial sparked by a discovery by a U.Va. neuroscience team. Researchers are investigating the effectiveness of the drug in reducing an inflammatory response by the immune system in response to COVID-19.

Dr. William Petri, chief of the University’s Division of Infectious Diseases and International Health, explained that the main problem with COVID-19 infections is that there appears to be an unsynchronized and hyperactive immune response which leads to excessive inflammation, which can be harmful to some patients. 

“We've actually seen that in patients at [the] U.Va. hospital … a specific kind of an immune response made by a cytokine — or an immune signaling molecule called interleukin-13 — leads to respiratory failure,” Petri said. 

Overproduction of cytokines — small proteins secreted by the immune system that regulate immunity and inflammation — can lead to “cytokine storms,” a severe immune response that releases a large number of cytokines in reaction to a disease or infection too quickly. When this occurs, the body begins to attack its own cells rather than using its resources to fight off the invading virus. These cytokine storms are believed to occur in severe COVID-19 cases. 

Last year, University neuroscientists Alban Gaultier and Dorian Rosen discovered that Fluvoxamine reduces the production of cytokines during research into the drug’s effects on sepsis — a life threatening complication of infection and inflammation in which the immune system spirals out of control. Fluvoxamine is an antidepressant drug that is typically used to treat Obsessive-Compulsive Disorder. Based on this discovery, a team at the Washington University School of Medicine in St. Louis launched a clinical trial in May to study the drug’s ability to prevent the overproduction of cytokines in COVID-19 patients.

The 15-day clinical trial was conducted with 152 adult participants who had a COVID-19 infection but were healthy enough not to require hospitalization. In comparing Fluvoxamine with a placebo, researchers found that of the 80 participants that received Fluvoxamine, none of them became seriously ill during the trial. Of the patients that received the placebo, six patients became seriously ill — four of those six patients were hospitalized.

The researchers acknowledge that the trial had some drawbacks. Firstly, it was conducted on a small number of participants, which limits the insights that can be drawn from it, as the sample size is not large enough to be representative of the overall population, preventing findings from being extrapolated. Additionally, 20 percent of participants — around 30 people — stopped answering surveys during the trial. The Washington University team was able to determine that none of those participants were hospitalized or required visits to the emergency department, but they couldn’t be sure that the participants did not receive treatment elsewhere.

The team has also noted that recent research has questioned cytokines' role in COVID-19 deaths. The researchers said that if that is the case, there might be some beneficial role of Fluvoxamine not yet understood.  

“There are several ways this drug might work to help COVID-19 patients, but we think it most likely may be interacting with the sigma-1 receptor to reduce the production of inflammatory molecules,” Assoc. Psychiatry Prof. Angela M. Reiersen of the Washington University team said.

The researchers explained that this trial shouldn’t be used to measure the effectiveness of the drug. However, they are very encouraged by the results and have moved on to a larger clinical trial of approximately 60,000 adults in phase three. 

“It’s always wonderful when basic research can translate at the human level,” Gaultier said.

He explained that one of the possible benefits of Fluvoxamine, if it successfully goes through phase three, would be how familiar and affordable it would be for hospitals as it is already used to treat other disorders. He spoke of the impact the drug would have in alleviating the financial and bed capacity burdens that health systems are under.

“The ability to prescribe a drug that can prevent complications … [is] very important,” Gaultier said. “We could help the health system and we can prevent the patient from developing long-term complications or being incubated or even worse, dying from COVID.”

Petri also emphasized how important the drug would be to current therapeutic efforts addressing COVID-19.

“This is a really important area of research in COVID-19 because right now the only thing that we have to offer as far as therapy … for people who are well enough to be at home is the monoclonal antibodies that President Trump received … and those are extraordinarily limited in supply,” Gaultier said.

In light of the Federal Drug and Enforcement Agency’s authorizations of the Pfizer and Moderna COVID-19 vaccines, Gaultier said that if Fluvoxamine proves effective at preventing worsening COVID-19 infections it would be another great tool for protecting the patients against COVID-19.

“[E]ven if we get good vaccinations, they will not protect everybody,” Gaultier said. “The best that we have now is 90 percent [efficacy], so we still have 10 percent of the population that could be in need of a new drug.”

According to the press release, the team published the trial results in the Journal of the American Medical Association. The research team was made up of Eric Lenze, Caline Mattar, Charles F. Zorumski, Angela Stevens, Julie Schweiger, Ginger E. Nicol, J. Philip Miller, Lei Yang, Michael Yingling, Michael S. Avidan and Angela Reiersen.