In the ongoing quest to identify the best and most efficient COVID-19 treatment plan, pharmaceutical company Eli Lilly is partnering with the National Institute of Allergy and Infectious Disease to explore the potential curing power of a drug called baricitinib.
What is Baricitinib?
Baricitinib, marketed as OLUMIANT® is currently approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. In initial clinical trials for the treatment of RA, Baricitinib was found to reduce or interrupt the passage of the virus into target cells, as well as to minimize the release of inflammatory agents.
Based on this anti-inflammatory activity, Baricitinib may be able to halt the inflammatory cascade seen in the progression of COVID-19. As explained in a clinical trial sponsored by the Hospital of Prato in Italy, “The evidence on the advantageous action of baricitinib on viral entry and cytokine outbreak constituted the rationale to perform a trial on patients with mild to moderate COVID-19 infection receiving baricitinib combined with antiviral therapy.”
Eli Lilly and Company and NIAIS Study Baricitinib in Adaptive COVID-19 Treatment Trial
On April 10, 2020, pharmaceutical giant Eli Lilly and Company announced it has entered into an agreement with the National Institute of Allergy and Infectious Disease (NIAID) to study Baricitinib as an arm in NIAID’s Adaptive COVID-19 Treatment Trial.
This study plans to investigate the safety and efficacy of Baricitinib as a potential treatment for hospitalized patients diagnosed with COVID-19.
“There is an urgent need for new strategies to help hospitalized COVID-19 patients, many of whom will progress to respiratory failure,” said Vincent C. Marconi, M.D., professor of medicine and global health at Emory University School of Medicine, one of the U.S sites for NIAID’s ongoing Adaptive COVID-19 Treatment Trial. “This NIAID study presents an important opportunity to test whether Baricitinib can help these patients.”
How Will the Clinical Trial Be Performed?
During the NIAID’s initial Adaptive COVID-19 Treatment Trial, more than 1,000 participants were treated with remdesivir, an investigational broad-spectrum antiviral treatment developed by Gilead Sciences, Inc. Clinical trial analysis found that COVID-19 patients treated with remdesivir had a “statistically significant shorter time to recovery compared to patients who received a placebo.”
Thanks to that trial, experts like NIAID Director Anthony Fauci, M.D. agree that, “We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19.”
The second part of the Adaptive COVID-19 Treatment Trial (ACCT 2) intends to, according to Dr. Fauci, “examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.”
In Arm 1 of the trial, participants will receive baricitinib tablets orally and remdesivir intravenously. In Arm 2 of the trial, participants will receive placebo tablets orally and remdesivir intravenously. As a double-blind study, neither trial investigators nor participants know which patients receive which treatment regimens.
By evaluating recovery time of Arm 1 participants to Arm 2 participants, investigators will identify whether baricitinib accelerates or inhibits COVID-19 recovery.