TABLE 1.
Baseline characteristics: Full Analysis Set
| Randomised treatment | Total | p-value | ||
| Plasma+SOC | SOC | |||
| Patients | 320 | 163 | 483 | |
| Age (years) | 62±14 | 62±14 | 62±14 | 0.772 |
| Male | 219/320 (68.4) | 113/163 (69.3) | 332/483 (68.7) | 0.842 |
| Ethnicity | 0.253 | |||
| Caucasian | 247/320 (77.2) | 135/163 (82.8) | 382/483 (79.1) | |
| North African | 39/320 (12.2) | 20/163 (12.3) | 59/483 (12.2) | |
| Middle Eastern | 16/320 (5.0) | 2/163 (1.2) | 18/483 (3.7) | |
| Black or Sub-Saharan (Africa) | 10/320 (3.1) | 2/163 (1.2) | 12/483 (2.5) | |
| Asian | 5/320 (1.6) | 2/163 (1.2) | 7/483 (1.5) | |
| Latino or Hispanic | 3/320 (0.9) | 2/163 (1.2) | 5/483 (1.0) | |
| BMI (kg·m−2) | 29±5 (n=264) | 30±6 (n=140) | 29±6 (n=404) | 0.173 |
| History of diabetes mellitus | 98/320 (30.6) | 45/163 (27.6) | 143/483 (29.6) | 0.528 |
| Insulin dependent | 29/320 (9.1) | 17/163 (10.4) | 46/483 (9.5) | 0.628 |
| Oral antidiabetics | 77/320 (24.1) | 23/161 (14.3) | 100/481 (20.8) | 0.013 |
| Smoking status | 0.759 | |||
| Active | 15/316 (4.8) | 10/159 (6.3) | 25/475 (5.3) | |
| Former | 98/316 (31.0) | 47/159 (29.6) | 145/475 (30.5) | |
| Never | 203/316 (64.2) | 102/159 (64.2) | 305/475 (64.2) | |
| COPD | 29/317 (9.2) | 16/160 (10.0) | 45/477 (9.4) | 0.743 |
| Asthma | 32/317 (10.1) | 16/160 (10.0) | 48/477 (10.1) | 1.000 |
| Heart failure | 26/318 (8.2) | 14/159 (8.8) | 40/477 (8.4) | 0.861 |
| Ischaemic heart disease | 41/317 (12.9) | 26/158 (16.5) | 67/475 (14.1) | 0.328 |
| Chronic kidney disease | 44/320 (13.8) | 20/159 (12.6) | 64/479 (13.4) | 0.777 |
| Kidney disease requiring dialysis | 3/318 (0.9) | 3/158 (1.9) | 6/476 (1.3) | 0.379 |
| Active cancer | 20/319 (6.3) | 9/162 (5.6) | 29/481 (6.0) | 0.841 |
| HIV/AIDS | 3/308 (1.0) | 0/157 (0.0) | 3/465 (0.7) | 0.554 |
| Chronic systemic corticosteroid therapy | 27/317 (8.5) | 17/161 (10.6) | 44/478 (9.2) | 0.504 |
| Other immunosuppressive therapy | 22/318 (6.9) | 17/161 (10.6) | 39/479 (8.1) | 0.215 |
| Highest body temperature (°C) | 37.6±1.0 (n=316) | 37.7±1.0 (n=162) | 37.7±1.0 (n=478) | 0.171 |
| Lowest oxygen saturation when breathing room air (%) | 91.0 (88.0–93.0) (n=272) | 91.0 (86.0–94.0) (n=127) | 91.0 (87.0–93.0) (n=399) | 0.792 |
| Oxygen therapy | 0.599 | |||
| No | 36/320 (11.3) | 21/163 (12.9) | 57/483 (11.8) | |
| Yes | 284/320 (88.8) | 142/163 (87.1) | 426/483 (88.2) | |
| Consciousness level | 1.000 | |||
| Alert | 310/320 (96.9) | 157/163 (96.3) | 467/483 (96.7) | |
| Verbal | 9/320 (2.8) | 5/163 (3.1) | 14/483 (2.9) | |
| Pain | 1/320 (0.3) | 1/163 (0.6) | 2/483 (0.4) | |
| Disease triage at admission | 0.698 | |||
| Ward | 262/320 (81.9) | 135/161 (83.9) | 397/481 (82.5) | |
| Intensive care unit | 48/320 (15.0) | 23/161 (14.3) | 71/481 (14.8) | |
| Emergency room | 10/320 (3.1) | 3/161 (1.9) | 13/481 (2.7) | |
Data are presented as n, mean±sd, n/N (%) or median (interquartile range), unless otherwise stated. SOC: standard of care; BMI: body mass index; COPD: chronic obstructive pulmonary disease. Continuous variables were compared using the two-sample t-test. Categorical variables were compared using the Chi-squared test.