6/28/23, 12:03 AM CARDEA Pathway Feedback Search Clinical Topics Home Studies CARDEA CARDEA Disease COVID 19 infection Trial question What is the role of auxora, a calcium release-activated calcium channel inhibitor, in patients with severe COVID-19 pneumonia? Study design Multi-center Double blinded RCT Population Characteristics of study participants 33.0% female N = 261 67.0% male 261 patients (85 female, 176 male) Inclusion criteria: adult patients with 1 symptom consistent with COVID-19 infection and pneumonia Key exclusion criteria: receipt of either non-invasive or invasive mechanical ventilation; expected survival < 7 days; PaO /FiO 75 at the time of screening; multiple organ dysfunction or failure; shock Interventions N=130 auxora (4-hour intravenous infusion of 1.25 mL/kg on day 1, and 1.0 mL/kg on day 2 and 3) N=131 placebo (4-hour intravenous infusion of matching placebo) Primary outcome Time to recovery at day 60 https://web.pathway.md/studies/recq1ySVZ0aVuhcbf 1/2 6/28/23, 12:03 AM CARDEA Pathway 10.0 days 10 7.5 days 7 5.0 days 2.5 days No significant difference 0.0 days Auxora Placebo No significant difference in time to recovery at day 60 (7 days vs. 10 days; AD -3 days, 95% CI -6.56 to 0.56) Secondary outcomes No significant difference in death from all causes at day 60 (13.8% vs. 20.6%; ARD -6.75, 95% CI -15.75 to 2.24) Significant decrease in death from all causes at day 30 (7.7% vs. 17.6%; ARD -9.86, 95% CI -17.8 to -1.93) No significant difference in the percentage of patients who undergone invasive mechanical ventilation at day 60 (19% vs. 28%; ARD -9, 95% CI -22.37 to 4.37) Safety outcomes No significant difference in serious adverse events. Conclusion In adult patients with 1 symptom consistent with COVID-19 infection and pneumonia, auxora was not superior to placebo with respect to time to recovery at day 60. Reference Charles Bruen, Mukhtar Al-Saadi, Edward A Michelson et al. Auxora vs. placebo for the treatment of patients with severe COVID-19 pneumonia: a randomized-controlled clinical trial. Crit Care. 2022 Apr 8;26(1):101. Open reference URL https://web.pathway.md/studies/recq1ySVZ0aVuhcbf 2/2