Table 1.
Baseline characteristics of study population (n = 316)
| IGAM group (n = 146) | Control group (n = 170) | p value | |
|---|---|---|---|
| Demographics | |||
| Age [years], mean (± SD) | 59.4 (± 12.7) | 62.5 (± 11.6) | 0.027 |
| Female sex, n (%) | 36 (24.7%) | 43 (25.3%) | 1.000 |
| Body mass index [kg/m2], mean (± SD) | 30.2 (± 5.8) | 31.9 (± 7.2) | 0.020 |
| Comorbidities, n (%) | |||
| None | 26 (17.8%) | 26 (15.3%) | 0.654 |
| Hypertension | 60 (41.1%) | 55 (32.4%) | 0.135 |
| Cardiovascular disease | 37 (26.9%) | 48 (28.2%) | 0.652 |
| Chronic heart failure | 18 (12.3%) | 13 (7.7%) | 0.228 |
| Chronic kidney disease | 22 (15.1%) | 17 (10.0%) | 0.232 |
| Chronic obstructive pulmonary disease | 13 (8.9%) | 10 (5.9%) | 0.416 |
| Diabetes mellitus | 41 (28.1%) | 60 (35.3%) | 0.211 |
| Malignant disease | 34 (23.3%) | 14 (8.2%) | < 0.001 |
| Permanent medication, n (%) | |||
| None | 41 (28.1%) | 51 (30.0%) | 0.803 |
| ACEI | 31 (21.2%) | 46 (27.1%) | 0.284 |
| ARB´s | 18 (12.3%) | 33 (19.4%) | 0.120 |
| Beta blockers | 52 (35.6%) | 54 (31.8%) | 0.546 |
| Platelet aggregation inhibitors | 33 (22.6%) | 43 (25.3%) | 0.670 |
| Anticoagulants | 13 (8.9%) | 18 (10.6%) | 0.755 |
| Corticosteroids | 21 (14.4%) | 18 (10.6%) | 0.395 |
| Immunosuppressive agents | 18 (12.3%) | 7 (4.1%) | 0.013 |
| Polypharmacy (≥ 5 drugs) | 53 (36.3%) | 71 (41.8%) | 0.381 |
| Status at ICU admission | |||
| Time between symptom onset and ICU admission, median (IQR) | 9 [5, 14] | 9 [6, 14] | 0.986 |
| Respiratory Support | 0.711 | ||
| Supplemental oxygen, n(%) | 23 (15.8%) | 24 (14.1%) | |
| High-flow oxygen device, n(%) | 25 (17.1%) | 38 (22.4%) | |
| Non-invasive ventilation, n(%) | 21 (14.4%) | 23 (13.5%) | |
| Mechanical ventilation, n(%) | 77 (52.7%) | 85 (50%) | |
| APACHE-II score | 18.0 (± 8.7) | 16.9 (8,1) | 0.233 |
| SARS-CoV-2 virus load [CT value]; mean (± SD) | 26.5 (± 5.9) | 28.4 (6.31) | 0.072 |
| COVID-19 course—day with highest disease severity* | |||
| Days after ICU admission [days], median (IQR) | 4 [1; 8] | 3 [1; 6] | 0.015 |
| Respiratory Support | 0.294 | ||
| Supplemental oxygen, n(%) | 3 (2.1%) | 3 (1.8%) | |
| High-flow oxygen device, n(%) | 6 (4.1%) | 15 (8.8%) | |
| Non-invasive ventilation, n(%) | 13 (8.9%) | 10 (5.9%) | |
| Mechanical ventilation, n(%) | 124 (84.9%) | 142 (83.5%) | |
| Horowitz index [PaO2/FiO2], median (IQR) | 88 [69; 139] | 105 [75; 163] | 0.011 |
| Pinsp [cmH2O], median (IQR) | 27 [23; 30] | 27 [23; 30] | 0.635 |
| PEEP [cmH2O], median (IQR) | 12 [10; 14] | 12 [10; 14] | 0.327 |
| Murray score; median (IQR) | 13 [10; 14] | 12 [9; 14] | 0.027 |
| SOFA score; median (IQR) | 10 [8; 13] | 9 [7; 12] | 0.022 |
| AKI KDIGO stage, n (%) | 0.335 | ||
| No acute renal injury | 73 (50.0%) | 100 (58.8) | |
| 1 | 17 (11.6%) | 21 (12.4%) | |
| 2 | 8 (5.5%) | 6 (3.5%) | |
| 3 | 48 (32.9%) | 43 (25.3%) | |
| Vasopressor support, n (%) | 119 (81.5%) | 129 (75.9%) | |
| SARS-CoV-2 virus load [CT value]; mean (± SD) | 24.6 (± 7.0) | 30.1 (± 6.0) | < 0.001 |
| Laboratory values—of day with highest disease severity*; median (IQR) | |||
| Leukocyte count [1000/µL] | 11.9 [8.0; 20.1] | 11.7 [8.4; 16.2] | 0.760 |
| Neutrophile count [1000/µL] | 9.1 [6.3; 14.6] | 9.6 [6.5; 13.8] | 0.688 |
| Lymphocyte count [1000/µL] | 0.9 [0.5; 1.5] | 0.9 [0.5; 1.4] | 0.907 |
| C-reactive protein [mg/L] | 153 [113; 262] | 149 [83; 206] | 0.082 |
| Procalcitonin [ng/mL] | 0.9 [0.3; 3.0] | 0.5 [0.2; 1.2] | 0.001 |
| Interleukin-6 [pg/mL] | 247 [82; 741] | 139 [60; 376] | 0.038 |
| Ferritin [µg/L] | 1638 [935; 4261] | 1304 [668; 2237] | 0.004 |
| Platelet count [1000/µL] | 179 [116; 281] | 246 [158; 336] | 0.001 |
| Serum creatinine [mg/dL] | 1.13 [0.74; 1.63] | 0.93 [0.69; 1.56] | 0.162 |
| D-dimers [µg/mL] | 2.67 [1.41; 7.1] | 2.37 [1.2; 4.62] | 0.199 |
| Total bilirubin [mg/dL] | 0.8 [0.5; 1.8] | 0.6 [0.4; 1.1] | 0.009 |
| IgM serum concentration [mg/dL] | 67 [29; 122] | 80 [63; 115] | 0.052 |
| IgA serum concentration [mg/dL] | 200 [148; 282] | 248 [189; 327] | 0.089 |
| IgG serum concentration [mg/dL] | 772 [553; 1060] | 916 [784; 1063] | 0.048 |
| Adjunctive therapies; n (%) | |||
| Corticosteroids | 125 (85.6%) | 139 (81.8%) | 0.442 |
| Interleukin-6 receptor antagonist | 12 (8.22%) | 22 (12.9%) | 0.243 |
| Remdesivir | 22 (15.1%) | 36 (21.2%) | 0.210 |
| IGAM treatment characteristics; median (IQR) | |||
| Initiation time [days after ICU admission] | 4 [1; 11] | n/a | |
| Treatment: duration [days] | 3 [3; 4] | n/a | |
| Treatment: daily dose [g] | 23.2 [17.6; 25.8] | n/a | |
Statistically significant p-values are presented in bold
ACEI angiotensin converting-enzyme inhibitor; ARB angiotensin II receptor blocker; ICU intensive care unit; APACHE-II score acute physiology and chronic health evaluation II score; CT cycle threshold; PaO2 partial pressure of oxygen; FiO2 fraction of inspired oxygen; PEEP positive end expiratory pressure; Pinsp inspiratory plateau pressure; SOFA score sequential organ failure assessment score; AKI acute kidney injury; KDIGO kidney disease: improving global outcomes; IGAM IgM-enriched intravenous immunoglobulins
*day of the most critical medical condition within the first 10 days after ICU admission