Table 1 Characteristics of patients with COVID-19-associated ARDs at trial inclusion, according to assigned treatment arm
From: FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial
Characteristic | FX06 (n = 25) | Placebo (n = 24) |
|---|---|---|
Age, y | 59 [53; 67] | 59 [53; 68] |
Sex | ||
Male | 19 (76) | 16 (67) |
Female | 6 (24) | 8 (33) |
Pre-existing condition | ||
Diabetes | 9 (36) | 6 (25) |
Hypertension | 11 (44) | 14 (58) |
Coronary artery disease | 4 (16) | 2 (8) |
Severe cardiovascular disease* | 0 | 0 |
Chronic respiratory disease | 1 (4) | 2 (8) |
Kidney disease† | 1 (4) | 0 |
Chronic liver disease | 0 | 0 |
Immunodeficiency | 0 | 0 |
Cancer | 0 | 3 (12) |
Body mass index, kg/m2 | 32 [28; 35] | 30 [27; 36] |
Simplified Acute Physiology Score II | 58 [41; 65] | 56 [38; 66] |
Days to inclusion | ||
From symptom onset | 14 [10; 18] | 12 [9; 14] |
From first positive PCR | 12 [10–16] | 9 [7–14] |
From oxygen therapy onset | 5 [1–7] | 3 [2–5] |
From invasive mechanical ventilation onset | 2 [2; 4] | 2 [2; 3] |
COVID-19 therapy use | ||
Corticosteroids | 25 (100) | 24 (100) |
Remdesivir | 0 | 0 |
Immunomodulator (tocilizumab or sarilumab) | 3 (12) | 3 (12) |
Other | 0 | 0 |
Respiratory support prior to intubation | ||
High flow oxygen device | 24 (96) | 19 (79) |
High flow oxygen device duration, days | 2.5 [0.25–5] | 2 [1–2.75] |
Non-invasive mechanical ventilation (NIV) | 8 (32) | 6 (25) |
NIV duration, days | 2 [1–3] | 1.5 [0–4.5] |
Respiratory status | ||
Tidal volume, mL/kg of PBW | 3.7 [2.7; 4.7] | 4.4 [3.0; 4.8] |
Plateau pressure, cmH2O | 26 [24; 28] | 25 [24; 27] |
Positive end-expiratory pressure, cmH2O | 12 [12; 15] | 12 [10; 14] |
Cstrs‡, mL/cmH2O | 26.2 [18.7; 29.4] | 27.8 [21.1; 38.7] |
FiO2 | 100 [60; 100] | 100 [64; 100] |
VV-ECMO | 10 (40) | 7 (29) |
Arterial blood gases | ||
PaO2, mmHg | 68 [60; 92] | 82 [70; 96] |
PaO2/FiO2§, mmHg | 102 [62; 145] | 110 [73; 187] |
PaCO2, mmHg | 42 [39; 47] | 42 [39; 44] |
Arterial pH | 7.43 [7.40; 7.46] | 7.40 [7.39; 7.46] |
Vasopressor use | 9 (36) | 9 (37) |
Serum creatinine, μmol/L | 66 [51; 86] | 66 [46; 97] |
C-reactive protein, mg/L | 102 [58; 159] | 120 [79; 215] |
Fibrinogenemia, g/L | 6.6 [5.8; 7.4] | 7.0 [6.0; 8.4] |
d-Dimers, mg/L | 2650 [1029; 8348] | 2625 [1335; 4872] |