In the COVA trial, sarconeos was found to be safe and effective in reducing risk for death or respiratory failure in patients hospitalized for COVID-19.
Girish Balachandran Nair, MD
In the phase 2/3 COVA trial, Girish Balachandran Nair, MD, and colleagues evaluated sarconeos, or BIO101, in hospitalized patients with COVID-19. “This agent activates the MAS receptor on the protective arm of the renin-angiotensin system (RAS), which may improve respiratory function,” explained Dr. Nair, who presented these findings at the 2023 American Thoracic Society International Conference, held from May 19-24, in Washington, DC. Researchers randomly assigned 233 patients who were hospitalized due to a COVID-19 infection 1:1 to receive sarconeos or placebo. The primary endpoint was the proportion of patients who experienced respiratory failure or death from any cause at day 28.
The primary endpoint was met: patients who were treated with sarconeos experienced significantly fewer events of respiratory failure or all-cause mortality than patients who were treated with placebo, as assessed by Cochran-Mantel-Haenszel statistics (adjusted difference, -11.4%; 95% CI, -22.4 to -0.4; P=0.043). According to Dr. Nair, these outcomes corresponded to a relative risk reduction of 44%. Furthermore, there was a trend toward a higher proportion of patients recovering or being discharged if they were treated with sarconeos instead of placebo (adjusted difference, 11.0%; P=0.057). As for safety, fewer patients in the sarconeos arm experienced treatment-emergent adverse events (TEAE; 57.0% vs 64.4%) or serious TEAEs (25.0% vs 30.8%). However, a larger proportion of patients in the sarconeos arm had increased gamma-glutamyl transferase levels at day 28 (≥2 x baseline or ≥5 x upper limit of normal; 20.3% vs 12.5%).
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