Hyderabad: At a time when the world is grappling with the coronavirus crisis, the National Institutes of Health (NIH) claimed that it has started a clinical study to test a combination of Gilead Sciences Inc's antiviral drug remdesivir and anti-inflammatory treatment baricitinib in COVID-19 patients.
The trial is presently enrolling adults hospitalized with COVID-19 in the United States and is expected to study the treatment combination in more than 1,000 participants.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that this study will look at whether adding an anti-inflammatory agent to remdesivir has additional benefits, including reducing mortality.
"We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19," Fauci added.
Read:WHO and European Investment Bank enhance efforts to combat COVID-19
Baricitinib, which is marketed under brand name Olumiant by Eli Lilly and Co, was being tested as a potential treatment for hospitalized patients diagnosed with COVID-19.
Interest in remdesivir has been high as there are no approved treatments or vaccines for COVID-19, the respiratory illness caused by the coronavirus, which has resulted in over 70,000 deaths in the country.
Remdesivir is administered as one 200-milligram (mg) IV dose followed by a 100-mg once-daily IV dose for the duration of hospitalization up to a 10-day total course of treatment. Baricitinib is administered as a 4-mg oral dose for the duration of hospitalization up to a 14-day total course of treatment.
Read:First patient dosed in FDA-Approved Phase III Lenzilumab study for COVID-19
Investigators will evaluate whether the time to recovery is shorter in the combination arm (baricitinib plus remdesivir), relative to remdesivir alone.
The trial will also compare other secondary outcome variables between treatment groups, including mortality alone.
It is to be noted that, earlier this month, the U.S. Food and Drug Administration authorized emergency use of the drug to treat COVID-19 and said its benefits outweighed risks.
Also Read:US: FDA warns against popping over-the-counter HCQ pills
