CARDEA
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
67.0% male
N = 261
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; PaO₂/FiO₂ ≤ 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
7 days
10 days
10.0 days
7.5 days
5.0 days
2.5 days
0.0 days
Auxora
Placebo
No significant
difference ↔
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 all-cause mortality at day 60 (13.8% vs. 20.6%; ARD -6.75, 95% CI -15.75 to 2.24).
Significant decrease in all-cause mortality at day 30 (7.7% vs. 17.6%; ARD -9.86, 95% CI -17.8 to -1.93).
No significant difference in 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.
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