Table 1. Baseline Patient Characteristics.
| Characteristics | No. (%) of patients | |
|---|---|---|
| Acetaminophen (n = 227) | Placebo (n = 220) | |
| Age, mean (SD), y [No.] | 63.9 (15.9) [227] | 64.2 (14.9) [219] |
| Age >75 y | 57 (25.1) | 55 (25.0) |
| Sex | ||
| Male | 115 (50.7) | 106 (48.2) |
| Female | 112 (49.3) | 114 (51.8) |
| Hispanic or Latino, No./total (%) | 31/222 (14.0) | 28/214 (13.1) |
| Race | n = 210 | n = 195 |
| American Indian or Alaska Native | 2 (1.0) | 0 |
| Asian | 6 (2.9) | 12 (6.2) |
| Black | 45 (21.4) | 32 (16.4) |
| Native Hawaiian or Other Pacific Islander | 4 (1.9) | 3 (1.5) |
| White | 153 (72.9) | 148 (75.9) |
| BMI, mean (SD) [No.] | 29.3 (10.2) [227] | 29.0 (9.4) [219] |
| Vasopressors at baseline | 174 (76.7) | 166 (75.5) |
| Assisted ventilation at baseline, No./total (%)a | 99/226 (43.8) | 86/219 (39.3) |
| High-flow nasal oxygen at baseline, No./total (%) | 33/226 (14.6) | 39/219 (17.8) |
| ARDS at baseline, No./total (%) | 41/226 (18.1) | 30/219 (13.7) |
| Time from inclusion to randomization, median (IQR), h [No.] | 9.6 (2.9-19.0) [224] | 9.7 (2.5-19.1) [215] |
| Screening hospital location | ||
| Intensive care unit | 128 (56.4) | 136 (61.8) |
| Emergency department | 95 (41.9) | 82 (37.3) |
| Floor | 2 (0.9) | 0 |
| Other | 2 (0.9) | 1 (0.5) |
| Step-down or intermediate unit | 0 | 1 (0.5) |
| Site of infection | ||
| Pneumonia | 100 (44.1) | 96 (43.6) |
| Urinary tract infection | 37 (16.3) | 52 (23.6) |
| Intraabdominal infection | 24 (10.6) | 19 (8.6) |
| Unknown | 22 (9.7) | 21 (9.5) |
| Skin or soft-tissue infection | 17 (7.5) | 16 (7.3) |
| Other source of infection | 15 (6.6) | 6 (2.7) |
| Influenza or other virus confirmed by testing | 8 (3.5) | 3 (1.4) |
| Central nervous system infection | 3 (1.3) | 4 (1.8) |
| Endocarditis or endovascular infection | 1 (0.4) | 1 (0.5) |
| Vascular catheter-related infection | 0 | 2 (0.9) |
| COVID-19 status ≤3 wk prior to admission | ||
| Positive | 17 (7.5) | 22 (10.0) |
| Negative | 163 (71.8) | 170 (77.3) |
| Unknown | 47 (20.7) | 28 (12.7) |
| Baseline measures | ||
| Creatinine, mean (SD), mg/dL | 1.6 (1.3) | 1.7 (1.3) |
| Outpatient creatinine ≤365 d , mean (SD), mg/dL [No.] | 1.1 (0.8) [164] | 1.2 (1.1) [157] |
| AST, mean (SD), U/L | 45.5 (35.0) | 40.9 (36.4) |
| ALT, mean (SD), U/L | 30.9 (26.6) | 31.4 (34.3) |
| Bilirubin, mean (SD), mg/dL [No.] | 0.9 (0.9) [225] | 0.9 (1.1) [218] |
| Platelets, mean (SD, × 103/μL [No.] | 218.9 (125.9) [226] | 221.1 (133.6) [220] |
| Platelets <50× 103/μL , No./total (%) | 15/226 (6.6) | 10/220 (4.5) |
| Total SOFA score, mean (SD)b | 5.5 (2.5) | 5.2 (2.5) |
| Plasma cell-free hemoglobin, mean (SD), mg/dL [No.] | 24.1 (60.3) [218] | 23.3 (64.9) [212] |
| Plasma cell-free hemoglobin, median (IQR), mg/dL [No.] | 8.3 (4.4-17.0) [218] | 8.5 (4.6-18.6) [212] |
| Prerandomization acetaminophen, No. (%) | 106 (46.7) | 91 (41.4) |
Abbreviations: ALT, alanine aminotransferase; ARDS, acute respiratory distress syndrome; AST, aspartate aminotransferase; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared), COVID-19, coronavirus-associated infectious disease 2019; SOFA, Sequential Organ Failure Assessment.
SI conversion factors: To convert ALT and AST from U/L to μkat/L, multiply by 0.0167; bilirubin from mg/dL to μmol/L, multiply by 17.04; creatinine from mg/dL to μmol/L, multiply by 88.4.
Assisted ventilation includes mechanical ventilation, noninvasive ventilation, or continuous positive airway pressure of 5 cm of oxygen or more but not high-flow nasal oxygen.
Scores were measured in the respiratory, cardiovascular, hematologic, renal, and coagulation systems, with each organ scored from 0 to 4, resulting in an aggregated score that ranges from 0 to 20, with higher scores indicating greater dysfunction. Twenty is the most severe. The Glasgow Coma Scale score was not included in the SOFA scoring.