Search jobs 09-Apr-2021 Lilly and Incyte announce results from the Phase 3 COV-BARRIER study of baricitinib in hospitalized COVID-19 patients
- Randomized, double-blind, placebo-controlled study of 1,525 patients did not meet statistical significance on primary endpoint (progression to non-invasive ventilation or invasive mechanical ventilation or death)
- Data showed 38% reduction in mortality by Day 28 (nominal p-value=0.0018) in patients treated with baricitinib in addition to standard of care, including corticosteroids and remdesivir
Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC. The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasiv
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INDIANAPOLIS (dpa-AFX) - Eli Lilly and Company (LLY) and Incyte (INCY) on Thursday said their late-stage study of baricitinib in hospitalized Covid-19 patients did not achieve the main goal.
The phase III study dubbed Cov-Barrier of baricitinib plus standard of care (SoC) versus placebo plus SoC did not meet statistical significance on the primary endpoint. The main goal was defined as the difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28.
The frequency of adverse events and serious adverse events were generally similar in the baricitinib and placebo groups, Eli Lilly said.
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INDIANAPOLIS, April 8, 2021 /PRNewswire/ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC. The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800).
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
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