Toronto Investigators Prepare Study of Favipiravir use in Long-Term Care Facilities to Protect Elderly from COVID-19

Jun 19, 2020 | Aging, COVID-19, Elderly, Long-Term Care Facilities, Nursing Home, SARS-CoV-2

Toronto Investigators Prepare Study of Favipiravir use in Long-Term Care Facilities to Protect Elderly from COVID-19

That horrific reality that long-term care facilities (nursing homes) have become the scene of mass death counters every purported societal value to care and protect those most vulnerable—our elderly. In Canada, over 80% of the deaths due to the SARS-CoV-2 pathogen occur here. Something has to be done to protect this vulnerable population. Hence, Health Canada approved a clinical trial to investigate whether the antiviral drug favipiravir, a version of which was recently approved in Russia as a COVID-19 treatment, can help stop or slow down outbreaks in long-term care homes. Led by Toronto based investigators from Sinai Health System’s Lunenfeld-Tanenbaum Research Institute, and St. Michaels Hospital, a study team will test the drug’s purported ability to inhibit COVID-19 cell replication and hence control outbreaks in long-term care facilities.

We have Failed our Elderly

In the age of COVID-19, long-term care facilities, known as “nursing homes,” have become high-risk locations. This is truly one of the tragedies of COVID-19. The elderly, particularly if in the lower socio-demographic category, face an already large list of health and social problems. The COVID-19 pandemic has made it that much worse. Last month, the Washington Post reported that 81 percent of deaths in Canada occur in such long-term care homes. Canada’s chief public health officer, Dr. Theresa Tam, reports as well that nursing home account for over 80 percent of COVID-19 deaths. In Ontario, the provincial government reports that outbreaks of COVID-19 have taken the lives of over 1,700 residents in long-term care facilities.

Although by May there were signs the SARS-CoV-2 pathogen was slowing in Canada, unfortunately, its “ruthless whip through long-term care facilities” continued at a frightening rate while Prime Minster Justin Trudeau acknowledged that Canada was “failing its elderly.”

Background

That health care professionals, along with first responders and those supporting the process of helping patients in this crisis, have been heroes during this world crisis is known to all that pay attention. This is certainly the case for health care workers at long-term care facilities for the elderly. Also, researchers have stepped up in a myriad of ways to counter COVID-19, and in conjunction with a pharmaceutical sponsor called Appili Therapeutics Inc., now will work in select Ontario long-term care facilities to test whether favipiravir can make a difference and save lives.

Favipiravir

With a trade name Avigan, this drug has demonstrated significant promise to fight the COVID-19 pandemic. For whatever reason, it hasn’t received the attention of a remdesivir form the U.S. health agencies despite the fact that it can be taken in tablet form. The drug is typically used to treat viruses, such as influenza, and works by impeding a cell’s ability to transform into a production factory for the SARS-CoV-2 pathogen, which serves to propagate viral infection.

Approved in Japan for influenza treatment in 2014, that nation included the drug in its emergency stockpile in anticipation of future influenza outbreaks. Most recently, TrialSite News reported that Russia approved its own generic version of favipiravir (called Avifavir) and a couple dozen studies are occurring around the world testing Avigan via its sponsor Japan’s FUJIFILM Toyama Chemical Co., Ltd. An antiviral like remdesivir—which has evidenced it can shorten the recovery time of COVID-19 patients from 15 to 11 days—again, Favipiravir can be taken in a tablet from which is ideal given the setting. Remdesivir must be administered intravenously.

The Study

Approved by Health Canada last month and led by investigators from both Sinai Health System’s Lunenfeld-Tanenbaum Research Institute and St. Michael’s Hospital, the partially blinded, randomized clinical trial will evaluate the efficacy of favipiravir in long-term care (nursing home) residents compared with a placebo to prevent COVID-19 outbreaks. Co-investigator Dr. Allison McGeer, senior clinician scientist at the Lunenfeld-Tanenbaum Research Institute at Sinai Health, reports, “If we have a drug that you reliably use to stop outbreaks after they have started, that would be extraordinarily helpful.”

The study will work with up to 16 long-term care homes in Ontario targeting up to 760 study subjects. As the study goal centers on determining whether Favipiravir can help stop or at least control COVID-19 outbreaks in long-term care homes, the investigators seek to enroll 250 homes in the Greater Toronto region over the next half-a-year so these facilities can quickly determine whether they want to participate in the study should an outbreak occur.

In statement concerning the study, co-investigator Peter Jüni, a senior epidemiologist with St. Michael’s Hospital, declared, “Given the strikingly high fatality rate from COVID-19 in long-term care facilities there is a particularly urgent need for randomized trials that explore ways of protecting the most vulnerable members of our society.”

The Research Centers

Lunenfeld-Tanenbaum Research Institute is a medical research institute in Toronto, Ontario, and is part of the Sinai Health System. Originally formed in 1985 as the Samuel Lunenfeld Research Institute, the research arm of Mount Sinai Hospital, by an endowment from the Lunenfeld and Kunin families. They are ranked in the top ten biomedical research institutes worldwide in terms of quality of science according to their website. This claim doesn’t include any reference. Their research budget hovers around $103 million per annum and they are home to 34 principal investigators, 15 associate scientists, and 215 trainees. They are purported to have the largest women’s and infant’s health research team in North America. They also are known for their diabetes research concentration.

St. Michael’s Hospital in Toronto is a teaching hospital and medical center. It was established by the Sisters of St. Joseph in 1892 with a founding mission of care for the sick and poor of Toronto’s inner city. Active in clinical research, St. Michael’s research is comprised of two main components, including 1) the Keenan Research Center for Biomedical Science (focuses on translational science research), and 2) Li Ka Shing Knowledge Institute (focuses on clinical and health services research). St. Michael’s Hospital is fully affiliated with the University of Toronto, the largest research entity in Canada. With a $76+ million research budget, St. Michaels’ Hospital in 2016, for example, published 90 times in high impact academic journals.

The Sponsor

Appili Therapeutics Inc. recently floated its stock in a market offering. They were founded in 2015 by a team of drug development, infectious disease and commercialization experts to advance the global fight against infectious disease and the mounting threat of drug-resistant pathogens. The company seeks to develop treatments targeting unmet need. According to Crunchbase, the company has raised just under $50 million since its inception. Its share price, at $1.02, gives it a market capitalization of $61.7 million as of this writing.  They recently raised $15.5 million on a public offering ($1.20 per unit) and a concurrent $1.4 million via private placement.

The company’s business model rests on the growing global threat of increasingly difficult-to-treat infections. As it turns out, many government incentive programs have emerged to encourage the development of new anti-infectives, making infectious disease both an increasingly appealing social and business value-driver that benefits patients and the health system alike. The company collaborates with a number of prominent organizations to serve a flexible model to address unmet needs.

Lead Research/Investigator

Dr. Allison McGeer, MD, FRCPC Microbiologist, Infectious Disease Consultant, Department of Microbiology, Lunenfeld-Tanenbaum Research Institute at Sinai Health

Peter Jüni, MD, FESC, Director Applied Health Research Centre, St. Michael’s Hospital

Source: Sinai Health

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