TrialSite has chronicled many favipiravir studies and that numerous countries, including Russia, India and China, have accepted the drug as a COVID-19 treatment at least on a provisional, emergency basis. The drug, currently approved in Japan for influenza, is now evaluated in clinical trials in the UK. Recently, a chief trial investigator Prof Kevin Blyth, of Glasgow University, shared, “It would be a huge step forward if antiviral drugs work.” He continued, “You don’t have any hospital services being put under enormous pressure because patients never come to the hospital,” saying, “Normal services can function and you don’t have to have lockdown or other draconian control measures.”
At the onset of the pandemic, initial research sponsored by the National Institutes of Health and other apex research bodies emphasized vaccines and novel therapeutics such as monoclonal antibodies. The success stories are well celebrated by the press, but at what cost? With a high death toll, critics argue that the government should have been focusing earlier on repurposed therapeutics such as favipiravir. What the mainstream press doesn’t share but TrialSite has tracked is that this drug, which originated in Japan, has been approved for use by health authorities in Russia, Bangladesh, India and many other national jurisdictions. Noteworthy, the U.S. government spent over $200 million to study this drug just five years ago. The results were never disclosed with the public as reported by TrialSite. Importantly, a Canadian biotech is trying to commercialize a version of favipiravir for COVID-19. Appili Therapeutics is conducting a few studies in both Canada and the United States. Their partner, generic producer Dr. Reddy’s, submitted a request for market authorization with Health Canada back in December 2020.
Trial Details & Risk Reduction
The clinical trial is known as GETAFIX and has been ongoing since Q4 2020. The study’s hypothesis centers on the drug favipiravir and that it can effectively help care for mild to moderate early onset COVID-19 patients. This study offers an important opportunity to test the safety, tolerability and efficacy of this Japanese originated drug. Moreover, the study team looks into the pharmacokinetic and pharmacodynamic profile and explores the mechanisms of resistance in the context of SARS-CoV-2, the virus behind COVID-19.
As an open label, parallel group, two arm Phase 2/3 randomized controlled trial, this study includes a 1:1 treatment allocation ration. Patients are randomized to one of two arms with a primary endpoint looking at the superiority of favipiravir plus standard treatment compared to standard treatment alone.
Volunteers in Glasgow are being urged to sign up as soon as they get a positive Covid test, with a separate trial running in London.
The GETAFIX study is funded by the Chief Scientist Office Division (CSO) of Scotland and is supported by a grant from Cancer Research UK. The actual producer of the drug, FUJIFILM Toyama Chemical Co. Ltd. is actually donating the drug via an intermediary called Clinigen Group Plc, a pharmaceutical services company, for use by patients in the study.
Principal Investigator Point of View
Prof. Blyth was on the record recently with the Sun that the drug hopefully “may be able to reduce spread and the risk of outbreaks happening.” The investigator continued “ Certainly over the next six months we should be able to get an answer.” Prof Blyth said of the trial of favipiravir, which is sold under the brand name Avigan again produced by FUJIFILM Toyama Chemical Co. Ltd.
Research Site: Glasgow University
Changing the world is not only about making discoveries and creating new technologies. Informed leaders, creative thinkers and bold business minds have honed their skills at Glasgow. The talents of some of the UK’s most influential political figures have been nurtured here. Award-winning writers have developed their craft. Human rights activists have gained their voice.
We are a place that inspires ambitious people to succeed. A place where inquiring minds can develop their ideas. A place where talented people are given the space to realise their dreams.
Most importantly, we are open to the world. Our doors are open to the brightest minds, regardless of background, who wish to study at university. We are open to collaboration and the exchange of knowledge with other universities, government and business.
To continue to be a world-class and progressive university, we are dedicated to bringing inspiring people together to change the world.
Professor Kevin Blyth, Professor of Respiratory Medicine/Honorary Consultant in Respiratory Medicine, Honorary Professor (Institute of Cancer Sciences)