INDIANAPOLIS (Inside INdiana Business) — The National Institute of Allergy and Infectious Diseases has begun the fourth iteration of its Adaptive COVID-19 Treatment Trial. The trial will study the effectiveness of two drugs in the treatment of COVID-19, one of which is a drug developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY).
One group in the ACTT-4 study will receive the Lilly drug baricitinib, which was originally created to treat rheumatoid arthritis, in combination with remdesivir, which has already been approved on its own by the FDA for treatment of COVID-19 in hospitalized patients age 12 and older. Another group will receive dexamethasone in combination with remdesivir.
The study seeks to determine the effectiveness of the drugs in adults hospitalized with COVID-19 who require supplemental oxygen. Up to 1,500 patients at 100 sites in the U.S. and other countries will be enrolled in the trial over the next few months.
The NIAID says, to date, dexamethasone and baricitinib “are the only two therapies that reduce inflammation that have demonstrated efficacy for the treatment of hospitalized adults with COVID-19 in large, randomized clinical trials.” The drugs were previously studied in separate trials.
“However, the differences in study populations, mortality rates and endpoint data collected in the (previous) trials make it difficult to make firm conclusions about the value of the interventions in various patient populations,” the institute said in a news release. “ACTT-4 aims to determine whether baricitinib or dexamethasone, when administered with remdesivir, is more effective at preventing hospitalized adults on supplemental oxygen from progressing to requiring mechanical ventilation or death, among other outcomes, or if they are similar.”
Lilly has already received an Emergency Use Authorization from the FDA to use baricitinib to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients age 2 and older who require supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.