NHS Greater Glasgow and Clyde & University of Glasgow Commence Favipiravir Clinical Trial Targeting Early Intervention of COVID-19

NHS Greater Glasgow and Clyde & University of Glasgow Commence Favipiravir Clinical Trial Targeting Early Intervention of COVID-19

NHS Greater Glasgow and Clyde in collaboration with University of Glasgow now lead the first clinical trial in Scotland to investigate the efficacy of  favipiravir (Avigan), the antiviral drug approved in Japan for influenzas as well as in Russia for COVID-19. Favipiravir is approved on an emergency basis in India, China and elsewhere. Targeting over 300 patients infected with SARS-CoV-2, the virus behind COVID-19, this drug originates from Japan’s Fujifilm Toyama Chemicals. Many people in the United States, for example, are not aware that not only is favipiravir approved in some places, at least on an emergency basis as a treatment for COVID-19, but that it’s economical and taken in convenient pill form. In fact, the U.S. government invested over $200 million in favipiravir clinical trials just five years ago. The results of these studies were never disclosed. Apparently, given that favipiravir shows early promise in places like China and Japan, the NHS Greater Glasgow and Clyde health board, the largest in the UK (serving over 1.2 million people) sought out a trial to determine the safety and efficacy of this potential early-stage COVID-19 therapy.

Background

Earlier in the year, a randomized study involving the study drug favipiravir commenced in London. TrialSite has chronicled favipiravir investigations and approvals in places such as Russia, emergency authorizations in India as well as China and elsewhere. A group in Russia developed a generic version known as Avifavir while India has multiple generic versions of the drug on the market. The U.S. Department of Defense sponsored a major Favipiravir study five years ago. The results were never disclosed.

Some influential people in Scotland are upbeat. Dr. Janet Scott with the Medical Research Council—University of Glasgow Center for Virus Research was recently quoted “This drug is active against many viruses, it is used already for influenza in Japan.” She continued, “We are able to offer it not just to patients in the hospital but also for home use.” Dr. Scott emphasized, “Our hope is that it will stop mild symptoms developing into serious ones. We are targeting volunteers who are at high risk of progressing to serious COVID-19 such as those over 60 years old or with underlying health problems.”

Early Intervention: The Great Gap in Care

TrialSite has chronicled physician after physician pleading that more research must go into early care for those mild to moderate COVID-19 cases. To date, large public expenditure was injected into vaccines and monoclonal antibodies for acute care. The problem: most cases are mild and home treatment represents an economical and important gap in care. Although the vaccine is absolutely needed, so desperately is early care treatment.

That’s why this trial focuses on patients with milder symptoms who may face higher risk for disease progression, for a variety of reasons. In this case, the treatment commences within four days of a positive COVID-19 swab test. The patient can take the antiviral tablets at home or at the clinic.

Half of the patients will receive the drug twice a day for ten days coupled with standard of care treatment while the other half will receive standard of care treatment and the study team will monitor and ultimately assess which group fared better.

The Study

According to a recent NHS press release, this study, named the Glasgow Early Treatment Arm Favipiravir (Getafix), results from a collaboration between the Health Board and the University of Glasgow. The study team will investigate how well the drug not only stops COVID-19 symptoms but also reduces recovery time.

Led by Professor Rob Jones who serves as chief investigator of the study as well as director of the Cancer Research UK Clinical Trials Unit in Glasgow, the study seeks to identify more immediate approaches to alleviating the crisis in Scotland and the UK. The recent vaccine news coming from Pfizer/BioNTech and Moderna is truly promising but a whole lot of suffering and death continues right now in key global hotspots. 

Professor James commented, “Although hopes are high ongoing vaccine trials will help prevent infection, this trial aims to improve current treatment for those unlucky enough to contract it.” He continued, “With the Getafix trial, we will be rapidly looking at whether this antiviral treatment may help kill off the virus in those affected and prevent more serious complications.”

Trial Site Locations

The sponsors of this study include NHS Greater Glasgow and Clyde in collaboration with University of Glasgow while the actual point of care—the trial site location—includes Queen Elizabeth University Hospital, Glasgow Royal Infirmary and the Royal Alexandra Hospital in Paisley, Renfrewshire.

Study Funding

The study is actually funded by the Chief Scientist Office of the Scottish Government. 

Lead Research/investigator

Rob Jones, Professor of Clinical Cancer Research

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