Bausch’s Virazole is currently approved in the U.S. and Canada, among other countries around the world, for treating hospitalized infants and young children with severe lower respiratory tract infections as a result of respiratory syncytial virus (RSV).
Virazole is ribavirin for inhalation solution, a synthetic nucleoside designed to stop viral replication. Because of this, Bausch believes that, when combined with standard care of therapy, it may be effective in reducing the severity of COVID-19 infection.
The initial clinical study won approval from Health Canada, and Bausch expects it to begin within the next few weeks. It is set to be an open-label, interventional trial to evaluate the safety and efficacy of Virazole with two active arms comparing different dosing regimens of the therapy in combination with standard care.
Bausch is also in discussion with the FDA and other health authorities globally regarding more studies to evaluate Virazole as a COVID-19 treatment. The Bausch Foundation is also working to make Virazole free of charge in Italian hospitals.
“Virazole has demonstrated antiviral activity in treating severe pediatric respiratory infections, and we believe it may be a valuable agent in reducing respiratory distress in adults suffering from COVID-19,” Bausch chairman & CEO Joseph Papa said in the news release. “We are actively pursuing approval of our trial protocol around the world to test the efficacy and safety of Virazole in this patient population.”
Eli Lilly last week entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to study baricitinib as an arm in NIAID’s adaptive COVID-19 treatment trial.
The study is slated to investigate baricitinib as a potential treatment for COVID-19 patients, beginning this month in the U.S. with intended expansion into Europe and Asia. Lilly expects results within the next two months.
Baricitinib is an oral JAK1/JAK2 inhibitor marketed as Olumiant with approval in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis.
Lilly also announced that it will advance LY3127804, an investigational selective monoclonal antibody against angiopoietin 2, to Phase 2 testing in pneumonia patients with COVID-19, with a trial beginning later this month across multiple U.S. locations.
“Lilly is moving at top speed and using all available resources to help fight this pandemic,” Lilly chief scientific officer & president of Lilly Research Laboratories Dr. Daniel Skovronsky said in a news release. “Developing potential therapeutic medicines for COVID-19 is part of our vital and humanitarian mission. To be successful, we must combine resources, data and expertise, with government, academia and other companies. We look forward to seeing the results of baricitinib and anti-Ang2 clinical studies.”
Meanwhile, Care Access Research launched its COVID-19 clinical trials alliance to connect sites, sponsors and CROs to accelerate coronavirus trials for FDA approval of vaccines, drugs and diagnostics.
The alliance is designed to match research-enabled sites with study sponsors to make hundreds of sites available in one place, cutting out common delays when finding research sites for studies.
“It is critical for study sponsors to find clinical trial sites fast enough to avoid delays in trials. Each day lost means lives lost,” Care Access Research co-founder & CEO Ahmad Namvargolian said in a news release. “Now more than ever, the industry needs the ability to quickly connect research-capable clinics and hospitals with trial sponsors looking for them. This alliance gives sponsors a simple way to connect with sites around the globe to run their COVID-19 trials.”
These drugs are all being tested as hydroxychloroquine, the anti-malaria drug (sometimes used for rheumatoid arthritis, like baricitinib) touted by President Donald Trump as a potential treatment, is in a similar stage.
Last week, the National Institutes of Health announced the enrollment in Tennessee of the first participants in a clinical trial for hydroxychloroquine as a COVID-19 treatment.