Table 1.
Icatibant Group | SoC (Control) Group | |
---|---|---|
N = 37 | N = 36 | |
Median age (IQR), y | 49.0 (41.0–59.0) | 56.5 (46.8–70.2) |
Male sex, no. (%) | 27 (73.0) | 22 (61.1) |
Median body mass index (IQR), kg/m2 a | 28.2 (25.7–36.3) | 30.3 (26.3–33.0) |
Ethnicity, no. (%) | ||
Caucasian | 22 (59.5) | 16 (44.4) |
Other | 15 (40.5) | 20 (55.6) |
Median blood pressure (IQR), mmHgb | ||
Systolic | 120.0 (110.0–129.0) | 128.0 (115.0–133.0) |
Diastolic | 75.0 (71.0–80.0) | 75.5 (69.8–85.0) |
Median body temperature (IQR), °C | 36.4 (36.2–36.7) | 36.7 (36.4–36.8) |
Median respiratory rate (IQR), breaths/min | 21.0 (18.0–25.0) | 20.0 (18.0–22.0) |
Oxygen delivery system, no. (%) | ||
Nasal cannula | 10 (27.8) | 12 (33.3) |
Venturi mask | 26 (72.2) | 24 (66.7) |
Median PaO2 (IQR), mmHgb | 71.0 (65.0–84.0) | 71.0 (63.8–79.2) |
Median FiO2 (IQR), unitless | 0.28 (0.21–0.32) | 0.28 (0.21–0.33) |
Median PaO2/FiO2 (IQR), unitless | 261.0 (212.0–317.0) | 263.0 (210.0–320.0) |
SpO2 (IQR), %c | 96.0 (95.0–97.0) | 96.0 (95.0–97.0) |
Median FiO2 (IQR), unitlessc | 0.30 (0.28–0.35) | 0.31 (0.28–0.35) |
Median SpO2/FiO2 (IQR), unitlessc | 326.0 (274.0–346.0) | 308.0 (275.0–343.0) |
Median heart rate, beats/min | 82.0 (70.0–90.0) | 82.5 (77.8–93.8) |
Median chest X-ray severity score, pointsd | 7.0 (4.0–9.0) | 6.5 (4.0–9.0) |
Median tomosynthesis severity score, pointsd | 7.5 (5.0–9.0) | 8.0 (5.0–11.5) |
Median C-reactive protein (IQR), mg/L | 87.1 (39.4–155.0) | 89.2 (45.6–137.0) |
Fully vaccinated against SARS-CoV-2, no. (%)e | 11 (29.7) | 13 (36.1) |
1 dose | 6 (42.9) | 6 (40.0) |
2 doses | 5 (37.5) | 7 (46.7) |
3 doses | 3 (21.4) | 2 (13.3) |
Abbreviations: FiO2, inspiratory oxygen fraction; IQR, interquartile range; PaO2, partial (arterial) oxygen pressure; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SoC, standard of care; SpO2, peripheral oxygen saturation.
The body mass index is the weight in kilograms divided by the square of the height in meters.
The conversion factor to Système International units (kPa) is 0.133.
Measured under oxygen supplementation.
Calculated as the sum of each of 6 lung regions (upper, middle, and lower right, and upper, middle, and lower left), scored as 0 = no findings, 1 = interstitial infiltrates, 2 = interstitial and alveolar infiltrates with an interstitial predominance, and 3 = interstitial and alveolar infiltrates with an alveolar predominance.
Fully vaccinated patients are those who were up to date with the recommended schedule at the time of randomization.