Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial

Table 2 Baseline demographics and clinical characteristics

	Arm A*		Arm B^†
	Auxora (n = 17)	SOC (n = 9)	Auxora (n = 3)	SOC (n = 1)
Age, years (mean ± SD)	59 ± 12	61 ± 13	64 ± 14	36 ± NA
Median BMI, kg/m² (min, max)	30 (25, 79)	30 (23, 49)	23 (18, 36)	34
Male sex, n (%)	7 (41)	5 (56)	1 (33)	1 (100)
Ethnicity, n (%)
White	8 (47)	5 (56)	1 (33)	0
Black or African American	7 (41)	3 (33)	1 (33)	1 (100)
Asian	0	1 (11)	1 (33)	0
Others/multiple	2 (12)	0	0	0
Hispanic or Latino, n (%)	2 (12)	1 (11)	0	0
Diabetes, n (%)	8 (47)	2 (22)	2 (67)	0 (0)
Hypertension, n (%)	8 (47)	4 (44)	2 (67)	0 (0)
Median time from the onset of symptoms to randomization, days (min, max)	9 (4, 34)	7 (4, 11)	11 (8, 17)	13
Ferritin, ng/mL (mean ± SD)	709 ± 553	772 ± 742	1776 ± 722	2151 ± NA
CRP, mg/dL (mean ± SD)	10 ± 7	12 ± 6	14 ± 11	9 ± NA
PaO₂/FiO₂ (mean ± SD)	178 ± 74	168 ± 78	106 ± 45	87 ± NA
PaO₂/FiO₂ ≥ 201	7 (41)	3 (33)	0	0
PaO₂/FiO₂ 101–200	6 (35)	4 (44)	2 (67)	0
PaO₂/FiO₂ ≤ 100	4 (24)	2 (22)	1 (33)	1 (100)
PaO₂/FiO₂ 101–200 ferritin ng/mL (mean ± SD)	867 ± 712	910 ± 1090	1637 ± 963	NA
PaO₂/FiO₂ 101–200 CRP mg/dL (mean ± SD)	11 ± 5	13 ± 9	16 ± 15	NA

Baseline demographics were balanced across the Auxora and standard of care groups in arm A. In arm B, baseline characteristics were more variable due to the small sample size
NA not available, SOC standard of care
*Patients in arm A included those who were receiving low-flow supplemental oxygen at screening and were defined by regulatory guidance as having severe COVID-19 pneumonia
^†Patients in arm B were defined by regulatory guidelines as having critical COVID-19 pneumonia

ISSN: 1364-8535