COVA trial: success for the investigational agent sarconeos in hospitalised COVID-19

Presented by

Dr Girish Balachandran Nair, Beaumont Hospital, MI, USA

Conference

ATS 2023

Trial

Phase 3, COVA

Doi
https://doi.org/10.55788/f986e767

The COVA trial demonstrated sarconeos to be safe and efficacious in patients who were hospitalised for COVID-19, significantly reducing the risk of death or respiratory failure without increasing the risk for adverse events.

Dr Girish Balachandran Nair (Beaumont Hospital, MI, USA) evaluated sarconeos, or BIO101, in hospitalised 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 [1]. In the phase 2/3 COVA trial (NCT04472728) that was initiated, 233 patients that were hospitalised due to a COVID-19 infection were randomised 1:1 to sarconeos or to 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 towards 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 experimental arm experienced treatment-emergent adverse events (TEAE; 57.0% vs 64.4%) or serious TEAE (25.0% vs 30.8%). However, a larger proportion of patients in the sarconeos arm had increased gamma-glutamyl transferase (GGT) levels at day 28 (≥2 x baseline or ≥5 x upper limit of normal; 20.3% vs 12.5%).

Nair G, et al. COVA study: results from a double-blind, placebo-controlled phase 2/3 study to assess efficacy and safety of BIO101 in hospitalized COVID-19 patients. D95, ATS International Conference 2023, 19–24 May, Washington DC, USA.

Medical Conferences

COVA trial: success for the investigational agent sarconeos in hospitalised COVID-19

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