europeanpharmaceuticalreviewOctober 16, 2020
Tag: COVID-19 , fluvoxamine , CETF , clinical trial
The COVID-19 Early Treatment Fund (CETF) has announced the results of a clinical trial that examined fluvoxamine in patients with mild COVID-19. The trial results indicated that fluvoxamine, if given early in the course of COVID-19, significantly reduced the likelihood of hospitalisation.
Researchers from the Washington University School of Medicine, US, shared the new data. They explain that fluvoxamine is a selective serotonin reuptake inhibitor (SSRI), a class of anti-depressants, mostly prescribed for people suffering from an obsessive-compulsive disorder. It was tested in coronavirus patients because fluvoxamine has very strong anti-inflammatory properties. The researchers believed this capability could prevent cytokine storms which result in inflammation, a key symptom of COVID-19.
Over 150 patients with mild forms of COVID-19 participated in the trial. They were randomly assigned to take either fluvoxamine or a placebo. As this was a remote, outpatient clinical trial, there was no face-to-face contact between participants and clinicians; study materials, including the study drug, were delivered to the participants’ homes. In this trial, of the 80 participants who received the drug, zero hit the endpoint of clinical deterioration, as opposed to the six of 72 people who got the placebo and deteriorated. The researchers say the results suggest that fluvoxamine may mitigate the risk of hospitalisation and death.
“Today, with all the focus on vaccines, we are neglecting to adequately fund research on the most promising existing drugs for treating this virus,” said Steve Kirsch, CETF founder. “COVID-19 will be with us for a while, so in addition to the vaccine studies, we should be focusing on testing drugs such as fluvoxamine, camostat, GS-441524 and doxazosin. Preventing serious illness and death should be the goal and repurposed drugs can be rolled out quickly to the benefit of millions worldwide. Virtually all of the funding for these outpatient trials is coming from a very small number of private donors. That needs to change. This trial provides strong evidence that drug repurposing may soon prove to be the fastest and least expensive way to end this pandemic.”
According to Dr Angela Reiersen, part of the study team: “In addition to inhibiting serotonin reuptake, fluvoxamine binds to a protein called the sigma-1 receptor. We think fluvoxamine’s action at the sigma-1 receptor may prevent the excessive release of cytokines, inflammatory molecules which can contribute to severe lung inflammation and the need for ventilator support.”
CETF and the researchers are now working rapidly on a larger remote outpatient clinical trial to validate these findings, with a goal to complete the larger trial by the end of the year.
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