Stanford Medicine reports that a study team will soon initiate the clinical trial investigating whether Favipiravir can reduce symptoms and viral shedding in people with COVID-19. As TrialSite News has reported, Stanford is one of just a few academic medical centers in the Untied States investigating this drug targeting COVID-19, a drug that has been approved in China, Russia, and India as a complimentary treatment to remdesivir. A few differences: remdesivir requires intravenous administration in the hospital and this test will be for oral use in mild cases. Favipiravir has gone generic, hence theoretically offers a lower price tag should it work and become approved. This is the first time the drug will be tested on outpatients in the United States.
Stanford plans to initiate the “Phase 2 randomized, double blinded, placebo controlled study of oral Favipiravir compared to standard supportive care in subjects with mild or asymptomatic COVID-19” in July 2020, reports Tracie White of Stanford. Targeting 120 participants, they will enroll those who were recently diagnosed but not in need of hospitalization. This is important as TrialSite News interviews with a number of researchers and doctors around the world, such as the recent Dr. Redondo interview, emphasizing the importance of early treatment to help prevent the progression of the disease.
The Stanford researchers will enroll participants who have been diagnosed with SARS-CoV-2 within the past 72 hours, reports Ms. White, a leading Stanford science writer. Each patient in the study will receive either a 10-day course of the investigational drug or a placebo. The subjects are thereafter evaluated for health outcomes over a 28 day duration.
Favipiravir in Demand Worldwide
The drug was developed in Japan by Toyama Chemical (Fujifilm Group) and was approved for use in Japan in 2014. By 2016, the Japanese company licensed the drug’s API to Zhejian Hisun Pharmaceutical Co. (China) and the drug went generic in 2019. In the meantime, researchers in China, Russia and India moved aggressively to identify the drug’s ability to act on SARS-CoV-2, the virus behind COVID-19. They found success and the drug is now approved in China, Russia, and India. The drug works by at the molecular level actually inhibiting a viral enzyme responsible for viral RNA production, and hence, impeding the virus’s ability to replicate itself reported one of the investigators named Marisa Holubar, MD. Most antivirals are optimized to work better the earlier upon contraction of the pathogen. Favipiravir is no exception.
In China, it is made and distributed by Zhejiang Hisun Pharmaceutical, while in India Glenmark Pharmaceuticals has made the move to develop “Fabiflu” targeting COVID-19. In Russia, it’s called Avifavir and the drug trials for this drug were supported by ChemRar and RDIF (a financier).
The hope is that Stanford investigators can reveal that the drug can reduce the severity of COVID-19 symptoms and shortening the duration of the infection caused by the pathogen. This would have the benefit of limiting the spread of the virus.
The principal investigator for the study is Yvonne Maldonado, MD, and professor of pediatrics and of health research and policy.
Aruna Subramanian, MD, works for Stanford as a clinical professor of medicine. One of the study’s investigators noted to the medical school’s news, “We hope that this drug can help to reduce transmission within families, groups and schools.” She continued, “Plus, it would be really nice to have pills that can be given early on to make people get better faster.”
Marisa Holubar, MD, clinical associate professor of infectious disease and an investigator for the Stanford Favipiravir study, reports, “Many really important studies are going on right now to help us understand how to emerge from this pandemic.” She continued, “These early-phase studies are important to inform larger clinical trials. We need to understand if favipiravir shortens the duration of viral shedding. It could be a key to protecting both ourselves and the broader community.”
Favipiravir vs. Remdesivir?
Stanford served as an investigational site for some of the remdesivir studies and of course the U.S. Food and Drug Administration (FDA) ultimately approved the antiviral drug as the first treatment for COVID-19. The drug is not available orally but rather requires intravenous administration to those in the hospital. But what about the majority of COVID-19 cases that are mild to asymptomatic?
Researchers, physicians and health policy leaders all agree that the more the duration of viral shedding can be reduced, the better for individuals and society.
Favipiravir, an investigational drug in the United States, has been approved in Russia, China, and India. If Stanford (and the other studies in the U.S.) can demonstrate evidence of efficacy and safety, then Favipiravir would complement Remdesivir as the latter would be used for those in the hospital while the former would be used for those outside of the hospital that have just contracted the virus.
U.S. Department of Defense Clinical Trials
Not reported much in the press (aside from here) is the fact that the U.S. Department of Defense (DOD) has made over $200 million in investment into the clinical research of the drug. As recently as 2015, the DOD along with a now defunct biotech company called MediVector were conducting Phase 3 clinical trials. A key figure in those studies was Dr. Armand Balboni who is now CEO of Canada’s Appili Therapeutics.
Yvonne Maldonado, MD and professor of pediatrics and of health research and policy, Principal Investigator
Aruna Subramanian, MD, infectious disease doctor, Investigator
Marisa Holubar, MD clinical associate professor of infectious disease, Investigator
Call to Action: If you are based in the Bay Area and interested in this study, reach out to the team to enroll at firstname.lastname@example.org.