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A The pill ordinarily prescribed to treat obsessive-compulsive disorder or anxiety disorder prevented symptoms from worsening in out-of-hospital Covid-19 patients compared to placebo, a small randomized controlled trial concludes, suggesting that the drug’s immunomodulatory effects may be explored further as a treatment for the disease.
The authors say their results, published Thursday in JAMA, do not demonstrate effectiveness because the study was so small and looked at relatively few measures of the disease. But experts say the idea deserves further study in a larger group of patients.
Researchers at the University of Washington in St. Louis have divided 152 patients diagnosed with Covid-19 in the previous seven days into two groups. Eighty were given fluvoxamine – a kind of antidepressant called SSRIs that also has a strong effect on inflammation – and 72 patients were given a placebo. After 15 days, none of the patients who received the drug saw their symptoms worsen – defined as shortness of breath and lower oxygen saturation – but six of the placebo patients worsened. Four of them were hospitalized and one required a ventilator to breathe. This deterioration rate of 8.3% in the placebo group is considered statistically significant.
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Nahid Bhadelia, an infectious disease specialist at Boston University, would also like to see preliminary data lead to larger trials and a better understanding of the possible biological mechanisms at work.
“It seems that a lot of the antiviral candidates have shown limited or early benefits, which really highlighted for me how serious the disease is immune-related, ”she told STAT. “An ambulatory drug that is oral and reduces disease progression would be a great addition to our arsenal.”
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Antiviral monoclonal antibodies, such as Eli Lilly Bamlanivimab, which received emergency use authorization this week, is an IV drug. They can help, said Bhadelia, “but the infusion aspect makes it more difficult to provide it to a large group of people. An oral candidate could help overcome access and equity issues if larger trials show effectiveness. “
Previous studies have shown that fluvoxamine attenuates the inflammatory response during sepsis, an overwhelming infection. The drug stimulates an immune receptor which controls the amount of cytokine produced. ‘Cytokine storms’ have been accused of triggering severe cases of Covid-19, as part of an over-reactive immune response worse than the coronavirus it seeks to destroy, although recent research has thrown a shadow over this interpretation. The authors of the new study cite a recent report, for example, which found lower levels of cytokines in patients with severe Covid-19 compared to patients with bacterial sepsis.
Their study on fluvoxamine was conducted remotely, with the drug or placebo and other supplies delivered to patients’ homes, including thermometers and devices to check their blood pressure and oxygen saturation. Patients reported their oxygen saturation, vital signs, whether they were taking their medication and how their Covid-19 symptoms were feeling over the phone or the internet.
In each group, about 70% were white, about a quarter were black, and the rest were Asians or their race was unknown.
Eric Topol, director of the Scripps Research Translational Institute, described the study as interesting a drug that has not received much attention, a putative modulator of the immune response.
“The good part is that it was tested for early disease, for which we have nothing but potentially monoclonal antibodies,” he told STAT. “The encouraging results are countered by multiple limitations (as the authors rightly acknowledged), so I would say this is now a candidate drug intervention looking for an actual randomized trial, more broad and rigorous.
Steven Nissen, cardiologist at the Cleveland Clinic, said he was “moderately skeptical” about small study with self-reported results, highlighting limitations listed in the study itself. “He’s statistically fragile. Extremely fragile, ”he told STAT.
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