The COVID-19 pandemic exposed on a global scale a multitude of challenges, including the drug development system itself—the bias toward advanced, high-cost novel vaccines and therapies over the aggressive investigation into existing, U.S. Food and Drug Administration (FDA) approved, so-called repurposed therapies. But some breakthroughs were made, thanks to a group called the COVID-19 Early Treatment Fund (CTEF). Formed by Silicon Valley tech entrepreneur Steve Kirsch, this group sponsored the initial clinical trials that led to positive results; and ultimately, a major clinical trial funded by Fast Grants and the Rainwater Charitable Foundation called the TOGETHER trial. McMaster University’s Dr. Edward Mills led the multinational study with the study results published in The Lancet on October 27, 2021. With little to no media coverage, the Canadian and Brazilian led team found that the use of fluvoxamine (100 mg twice daily for 10 days) by high-risk outpatients with early diagnosed COVID-19 reduced hospitalization by 32%. Moreover, Kirsch has shared previously with TrialSite that study data indicate participants participating in the early fluvoxamine research interestingly, haven’t manifested long COVID-19. Finally, an expert panel set up to guide Canada’s most populated province formally endorsed the drug for COVID-19. This economical antidepressant represents a compelling option now in the war against COVID-19. In this case, the drug is considered for mild COVID-19 patients. The goal, of course, is to keep individuals out of the hospital. Last month a prominent group within Johns Hopkins University (including the globally ranked hospital) also included fluvoxamine in their COVID-19 treatment guideline. Could America’s National Institutes of Health (NIH) be next?

Ontario obtained what is known as the Science Table. An advisory group called the Ontario COVID-19 Science Advisory Table, this group of scientific experts as well as health system heads get together on an ongoing basis to study, evaluate and track emerging evidence linked to the COVID-19 pandemic in a bid to better inform the province.

An independent group hosted by the Dalla Lana School of Public Health, funding for the Scientific Director as well as the Secretariat of the group originates from the Dalla Lana School of Public Health and Public Health Ontario.

The Implication

As reported by Avis Favaro at CTV News, the selective serotonin reuptake inhibitor (SSRI) usually prescribed for depression or obsessive-compulsive disorders now can be considered by physicians in Canada’s most populated province.Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise

And the timing is right. This latest Omicron variant-driven wave of infections shattered previous records during the pandemic. Recently, on December 23rd, 20,699 infections were reported. Thankfully, the death rate in Canada is nowhere near close to levels seen during the first and second waves of the pandemic. But nonetheless, the danger of hospitalization and death is high. 

An associated professor of medicine at McMaster University Dr. Menaka Pai also happens to co-chair the Ontario COVID-19 Science Advisory Table, sharing with Ms. Favaro, “Right now, we’re in a really unprecedented wave of Omicron and we have just a staggering number of patients getting infected.” In relation to fluvoxamine, Dr. Pai declared “Our goal is to keep them safe, to keep them out of the hospital, and also to preserve our scarcest resource, which I would say is our hospital beds.”

Co-Principal Investigator Mills also went on the record with the Canadian media emphasizing to the public “It’s a very large treatment effect, one that hasn’t been observed for any drug yet.”

Johns Hopkins on Board

Johns Hopkins University has also embraced the repurposed drug for COVID-19 patients. Specifically, the JHMI Clinical Recommendations for Pharmacologic Treatment of COVID-19 updated on November 16, 2021, represents a joint effort between the COVID-19 Treatment Guidance Writing Group of Johns Hopkins University and the Johns Hopkins Hospital COVID-19 Treatment Guidance Working Group.

This influential group now includes fluvoxamine as an endorsed treatment for patients within seven days of symptom onset, excluding individuals pregnant and in the third trimester.

Conclusion

As part of the TrialSite Advisory Committee, Dr. Michael Goodkin recently declared fluvoxamine is “grossly underutilized.” With a material reduction in hospitalization rates (which impacts mortality rates), low cost, and widely available in the face of a massive Omicron-based wave of infections in Canada the medical leadership in Ontario just made a critically important move. CTV News reports other provinces In Canada now also have the drug as a candidate for endorsement.

Meanwhile, one of the most prestigious academic medical centers on the planet, Johns Hopkins Hospital, offers the therapy in certain circumstances.

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