Bausch Health has started a clinical trial program evaluating the investigational VIRAZOLE (Ribavirin) in combination with standard of care therapy to treat respiratory distress due to COVID-19.

The Canadian pharmaceutical firm said that its VIRAZOLE is a synthetic nucleoside that works to stop viral replication, and is thought to be effective in reducing the severity of COVID-19 infection.

Bausch Health chairman and CEO Joseph C Papa said: “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.

“We are actively pursuing approval of our trial protocol around the world to test the efficacy and safety of VIRAZOLE in this patient population. Bausch Health will remain focused, for as long as necessary on doing our part to help end this unprecedented global health pandemic, including donating our health care products, conducting research to find new treatment options.”

The study will evaluate VIRAZOLE in adult patients infected with COVID-19

Bausch is seeking the approval for additional studies to evaluate VIRAZOLE as a treatment for COVID-19 infection, from the US Food and Drug Administration and health authorities of different countries.

The drug has been currently approved in several countries around the world, including the US and Canada, for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV).

The company is also working directly with health authorities in Italy to offer VIRAZOLE for inhalation in Italian hospitals at free of cost.

The initial open-label and interventional clinical study has been approved by Health Canada and is expected to start within a few weeks.

The study is designed to evaluate the safety and efficacy of the drug in hospitalised adult patients, above 18 years of age, who have tested positive for COVID-19, and suffering from respiratory distress.

The two active study arms in the study would compare different dosing regimens of VIRAZOLE in combination with standard of care therapy.