Table 1.
Baricitinib plus standard of care group (n=51) | Placebo plus standard of care group (n=50) | ||
---|---|---|---|
Age, years | 58·4 (12·4) | 58·8 (15·2) | |
Sex | |||
Male | 25 (49%) | 30 (60%) | |
Female | 26 (51%) | 20 (40%) | |
Race | |||
American Indian or Alaska Native* | 15 (29%) | 17 (34%) | |
Asian | 0 | 1 (2%) | |
Black or African American | 1 (2%) | 1 (2%) | |
Multiple | 2 (4%) | 0 | |
White | 32 (63%) | 30 (60%) | |
Missing | 1 (2%) | 1 (2%) | |
Country | |||
Argentina | 12 (24%) | 9 (18%) | |
Brazil | 15 (29%) | 14 (28%) | |
Mexico | 14 (27%) | 17 (34%) | |
USA | 10 (20%) | 10 (20%) | |
Body-mass index, kg/m2 | 34·3 (7·8) | 32·1 (6·3) | |
Duration of symptoms before enrolment | |||
<7 days | 2 (4%) | 4 (8%) | |
≥7 days | 49 (96%) | 44 (88%) | |
Missing | 0 | 2 (4%) | |
Duration of hospitalisation before randomisation, days | 4 (2–7) | 4 (2–7) | |
Key concomitant medications at baseline | |||
Remdesivir use | 0 | 2 (4%) | |
Corticosteroid use | 43 (84%) | 44 (88%) | |
Pre-existing comorbid conditions of interest† | |||
Obesity | 28 (55%) | 29 (58%) | |
Diabetes (type 1 and type 2) | 20 (39%) | 16 (32%) | |
Chronic respiratory disease | 1 (2%) | 2 (4%) | |
Hypertension | 31 (61%) | 24 (48%) | |
Vasopressor use at baseline | 32 (63%) | 31 (62%) | |
Renal replacement therapy use at baseline | 0 | 0 | |
ECMO use at baseline | 2 (4%) | 1 (2%) | |
NEWS‡ | 10·5 (2·0) | 10·6 (2·0) | |
Inflammatory markers | |||
C-reactive protein concentration, mg/L | 124·9 | 109·5 | |
D-dimer concentration, mg/L | 1·6 | 1·6 | |
Lactate dehydrogenase concentration, U/L | 499·5 | 543·6 | |
Ferritin concentration, pmol/L | 2622·0 | 2836·9 |
Data are mean (SD), median (IQR), median, or n (%). ECMO=extracorporeal membrane oxygenation. NEWS=National Early Warning Score.
Includes participants from Mexico and Latin America.
Patients with estimated glomerular filtration rate <30 mL/min per 1·73 m2 were excluded from study enrolment.
NEWS was used to detect and report changes in illness severity in participants with acute illness; participants on mechanical ventilation or ECMO were assigned a score of 3 for respiration rate regardless of the ventilator setting; participants on ECMO were assigned a score of 3 for heart rate because they were on cardiopulmonary bypass; the aggregate score is reflective of the participant's status, with higher scores representing higher level of acuity; a score of 7 or greater reflects high clinical risk for worsening acuity.