Posts tagged with "Alban Gaultier"

COVID-19 Trial Tests if Common Drug Can Keep Patients Out of Hospital

At-risk people diagnosed with COVID-19 across the United States and Canada can participate in a clinical trial testing whether a common drug can keep them from getting sicker and keep them out of the hospital.­­

The trial, conducted by Washington University School of Medicine in St. Louis, is based on a discovery by the University of Virginia School of Medicine’s Alban Gaultier, PhD, and a former graduate student, Dorian A Rosen, PhD.

Gaultier and Rosen found last year that the antidepressant fluvoxamine may stop the deadly inflammation known as sepsis, in which the immune response spirals out of control. The drug’s apparent benefit for dampening dangerous inflammation prompted the Washington University researchers to begin investigating its potential benefit for COVID-19, which can also cause dangerous overreactions of the immune system.

“If this clinical trial is proven successful, fluvoxamine could become a standard treatment for patients newly diagnosed with COVID-19, especially patients at risk,” Gaultier said. “Even the best vaccines do not protect 100% of the population, and discovery of safe and affordable treatments to prevent COVID-19-associated complications is critical.”

Fluvoxamine and COVID-19

Earlier this year, the Washington University researchers launched their first clinical trial of the drug in patients with COVID-19. That trial compared fluvoxamine with a harmless placebo in 152 adult outpatients. None of the 80 participants who received fluvoxamine became seriously ill after 15 days, while six patients who received placebo did. Of those six, four were hospitalized, for periods ranging from four to 21 days. One was on a ventilator for 10 days.

Based on those initial results, Washington University is now launching a much larger trial open to residents across the United States and Canada. The trial is seeking approximately 880 at-risk participants, age 18 and older, who have tested positive for COVID-19 and are experiencing mild symptoms.

Participants will be provided with either fluvoxamine or a placebo for approximately 15 days. No face-to-face contact is required; everything necessary will be sent to the participants’ doorsteps.

Contactless Check-Ins

The researchers will track the patients by videochat, email or telephone to determine if fluvoxamine provides a benefit and helps keep participants out of the hospital. During brief daily check-ins, trial participants will report their oxygen levels, blood pressure and temperature, along with whether they are feeling shortness of breath or have had any other problems.

The study team will continue to follow the participants for approximately 90 days after they have finished taking fluvoxamine or the placebo.

The trial is open to people who have at least one risk factor for severe COVID-19, such as being 40 or older, being part of a high-risk racial/ethnic group (such as African-American, Hispanic, Native American or biracial), or having one or more medical conditions such as obesity, diabetes, high blood pressure, heart disease, a lung disease or an immune disorder such as rheumatoid arthritis.

For more information about the trial, visit this website.

Kaelen Felix Illustrates a COVID-19 Article for 360 MAGAZINE

Antidepressant x COVID-19

Based on a trial from the University of Virginia School of Medicine, the antidepressant fluvoxamine appears to prevent COVID-19 infections from worsening, even keeping patients out of the hospital.

The clinical trial was conducted by the Washington University School of Medicine in St. Louis. Fluvoxamine was compared with a placebo in 152 adult patients who were infected with the coronavirus.

80 participants received the fluvoxamine, and not one of the 80 became seriously ill after 15 days. Six patients receiving the placebo became seriously ill with four being hospitalized for between four and 21 days. One of the four in the hospital was on a ventilator for 10 days.

Though the sample size was relatively small, the data is believed to be statistically significant. The plan is to launch a larger trial in coming weeks.

Eric J. Lenze, MD, of the Washington University School of Medicine, said patients who took fluvoxamine did not require hospitalization because of issues in lung function.

“Most investigational treatments for COVID-19 have been aimed at the very sickest patients, but it’s also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or to have to go to the hospital,” Lenze said. “Our study suggests fluvoxamine may help fill that niche.”

UVA’s Alban Gaultier, PhD, and former graduate student Dorian A. Rosen, PhD, found in 2019 that fluvoxamine may stop sepsis, a deadly inflammation causing the immune system to spiral out of control. The findings of Gaultier and Rosen inspired the tests at the Washington University School of Medicine.

Gaultier and Rosen determined that fluvoxamine reduces the production of cytokines, which have been linked to deadly cytokine storms, which are thought to occur in severe cases of COVID-19

“Because elevated cytokines levels have been associated with COVID-19 severity, testing fluvoxamine in a clinical trial made a lot of sense to us,” said Gaultier. “We are still unclear about the mode of action of fluvoxamine against SARS-CoV-2, but research is under way to find the answer.”

Washington University’s Angela M. Reiersen, MD, said the drug works by interacting with the sigma-1 receptor to reduce the production of inflammatory molecules.

“Past research has demonstrated that fluvoxamine can reduce inflammation in animal models of sepsis, and it may be doing something similar in our patients,” Reiersen said.

The limitations of the research were emphasized. The small sample size was noted along with the fact that 20% of participants stopped answering surveys during the trial. Though the researchers could rule out hospital visits for those who stopped answering, they did believe it possible that the participants sought treatment elsewhere.

Because of the limitations, the findings should be considered encouraging and worthy of further research rather than iron clad truth.

Gaultier said, “If a larger clinical trial (phase III) confirms the results, fluvoxamine would be a perfect treatment for COVID patients newly diagnosed. Fluvoxamine is not an experimental drug, it is cheap and safe and could be available as a first line of defense to unburden the hospitals that are overwhelmed by the COVID health crisis.”

For more medical research news from UVA, you can click right here.