The Bangladesh Society of Medicine (BSM) concluded from a recent study that Favipiravir evidences “clear cut” safety and effectivity against COVID-19. Apparently the “Dhaka Trial,” a randomized and controlled clinical trial conducted in Dhaka revealed similar positive effects of Favipiravir (Avigan) in COVID-19 patients as has been the case in China and Russia. The clinical trial sponsor, BSM, observed that of the patients in the clinical trial 96% were found to have negative test results (RT-PCR) after the Favipiravir treatment. Favipiravir is approved in multiple countries targeting COVID-19, including China, Russia and India. The U.S. Department of Defense spent over $200 million testing it in clinical trials just five years ago for exactly the kind of pandemic now faced. Why don’t Americans hear more about it?
The ‘Dhaka Trial’
This study’s protocol NCT04402203 was approved by the Directorate General Drug Administration (DGDA) and the Bangladesh Medical Research Council (BMRC). Called the Dhaka Trial, the double blinded, placebo controlled randomized clinical trial conducted in the nation’s largest city was reported on recently by Syed Gulam Mogni Mowla, assistant professor of the Department of Medicine at Dhaka Medical College and Hospital. Dr. Mala just presented the results to a seminar titled “Study on Safety and Efficacy of Favipiravir (Favipira) on COVID-19 patients in selected hospitals of Bangladesh,” sponsored by BSM along with Beacon Pharmaceuticals Ltd. (BPL) and held at the Dhaka Westin, reports The Daily Star. According to the study information disclosed in Clinicaltrials.gov, the principal investigators were Ahmedul Kabir, MBBS, FCPS, FACP, and Billal Alam, MBBS, FCPS, MD.
With 50 COVID-19 positive patients participating, after four days of Favipira treatment, 48% of the patients were COVID-19 negative and by the tenth day, that number came to 96%.
Other findings included:
· The patient group on Favipira showed lung function improvement three times higher than the placebo group
· The Favipira group had a 44% more viral clearance than those on the placebo
· The study team found the Favpira subjects had no significant side effects
Participating sites included Kuwait Bangladesh Friendship Government Hospital, Dhaka Mahanagar General Hospital, Kurmitola General Hospital, and Mugda Medical College and Hospital, Dhaka.
An Approved Antiviral Targeting COVID-19
The drug, known under the brand name of Avigan, was the intellectual property of Japan’s Toyama Chemical (Fujifilm Group) until it became generic in 2019. Now Beacon Pharmaceuticals will manufacture Favipiravir under the name Favipira, much like in India it’s called FabiFlu and made by Glenmark Pharmaceuticals. Russia has made a version called Avifavir.
Apparently, a number of companies are making this product now. Eskayef Pharmaceuticals produces a version called Favipir and supply it to providers to treat patients infected with SARS-CoV-2. Additionally, up to 14 other pharmaceutical companies such as Beximco, Renata, Orion Pharma and Square also make the drug.
Principal Investigator Comments
Professor Billal Alam was identified in the Clinicaltrials.gov U.S. database as one of the principal investigators. In the Daily Star, he was quoted, “We are pleased to reach a clear-cut decision for treating COVID-19 patients through the Dhaka trial conducted on our own patients.” The principal investigator thanked all the doctors, nurses, and health workers for their “tireless efforts.”
Favipiravir has been approved in Russia, China, India and now what appears to be a legitimate randomized controlled trial in Bangladesh provides evidence for the approval of the drug there. The U.S. Department of Defense, TrialSite News reported, spent over $200 million on clinical trials in ongoing Favipiravir testing several years ago. Although there are a couple Favipiravir clinical trials in the United States, why isn’t the National Institute of Allergy and Infectious Disease (NIAID) discussing this drug? Why does the press tend to avoid it in the United States while continuously discussing Remdesivir?