Auxora vs. placebo for the treatment of patients with severe COVID-19 pneumonia: a randomized-controlled clinical trial

Table 2 Primary and secondary endpoints in patients with a baseline imputed PaO₂/FiO₂ ≤ 200

	Placebo (n = 131)	Auxora (n = 130)	Difference (95% CI)	P value
Primary endpoint
Median time to recovery, days (95% CI)	10.0 (7.0, 14.0)	7.0 (6.0, 9.0)		0.0979
Secondary endpoints
All-cause mortality at Day 60, n (%)	27 (20.6%)	18 (13.8%)	− 6.75 (− 15.75, 2.24)	0.1449
All-cause mortality at Day 30, n (%)	23 (17.6%)	10 (7.7%)	− 9.86 (− 17.80, − 1.93)	0.0165
Invasive Mechanical Ventilation, Proportion of Patients Day 60 (95% CI)	0.28 (0.21, 0.37)	0.19 (0.13, 0.28)		0.1882
Invasive Mechanical ventilation or death, proportion of patients Day 60 (95% CI)	0.31 (0.24, 0.39)	0.23 (0.17, 0.31)		0.2994

Definition of Recovery by Ordinal Scale: 6 Hospitalized, not requiring supplemental oxygen or ongoing medical care; 7 Discharged, requiring supplemental oxygen; 8 Discharged, not requiring supplemental oxygen. Analysis of time to recovery through Day 60 in the efficacy set used log-rank test stratified by the baseline imputed PaO₂/FiO₂ ≤ 100 and 101–200; Analysis of all-cause mortality in the efficacy set used Cochran-Mantel–Haenszel test stratified by the baseline imputed PaO₂/FiO₂ ≤ 100 and 101–200. Patients with a baseline imputed PaO₂/FiO₂ > 200 were excluded from the efficacy set analysis

ISSN: 1364-8535