Skip to main content

Table 4 Main clinical outcomes

From: Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial

Primary endpoint UC-MSCs (n = 21) Placebo (n = 24) Estimate (95% CI) p value
PaO2/FiO2-ratio change D0–D7(principal analysis) 54.3 [− 15.5; 93.3] 25.3 [− 33.3; 104.6] 7.4 (− 44.7; 59.7) 0.77
PaO2/FiO2-ratio change D0–D7(sensitivity analysis) 54.3 [− 15.5; 93.3] 25.3 [− 33.3; 83.1] 12.5 (− 33.8; 56.7) 0.59
Secondary endpoints UC-MSCs (n = 21) Placebo (n = 24) Median difference (95% CI),
HR or sub-HR
p value
PaO2/FiO2-ratio change D0–D14 11.0 [− 39; 72.7] 28.2 [− 1; 67.3] 1.69 (− 82.1; 90.7) 1
Ventilation-free days to D28, n 17.0 [0; 25.0] 12.0 [0; 19.7] 0.5 (− 3.0; 8.0) 0.61
Ventilation duration to D28, n 9.0 [3.0; 20.0] 10 [5.7; 20.0] − 2.5 (− 8.0; 3.0) 0.38
Ventilation duration to D28 for recipients of 3 UC-MSC doses 11.0 [6.0; 24.0] 13.0 [7.0; 22.0] − 0.5 (− 8; 6) 0.79
SOFA-score change D0–D7 − 1.5 [− 2; 0.75] − 2 [− 3.2; 0.2] 0.5 (− 2.0; 3.0) 0.60
SOFA-score change D0–D14 − 0.5 [− 1.2; 1.0] − 3.0 [− 3; − 1.0] 1.5 (− 1.0; 5.0) 0.12
Organ-failure–free days to D14, n 3.0 [0; 6.0] 2.0 [0; 9.0] − 0.5 (− 4.0; 3.0) 0.96
Organ-failure–free days to D28, n 16.0 [2.0; 20.0] 15.0 [0.75; 23] − 0.5 (− 7.0; 4.0) 0.68
Days to reach PaO2/FiO2 > 200 5.0 [0; 16.0] 2.5 [0; 6.5] 0.74 [0.3; 1.6] 0.44
Days to reach PaO2/FiO2 > 300 12.0 [7.0; 23.0] 15.0 [5.0; 27.0] 1.1 [0.5; 2.3] 0.87
Days to ICU dischargea 15.0 [8.0; NA] 13.0 [5.5; 27] 0.8 [0.4; 1.7] 0.59
Days to weaningb 13.0 [9.0; NA] 17.0 [8.0; NA] 1.3 [0.5; 3.3] 0.55
Compliance change D0–D7 − 3.6 [− 11.8; 4.7] − 0.1 [− 4.5; 2.4] 0.4 (− 24.7; 25.5) 1
Compliance change D0–D14 − 3.0 [− 3.0; − 3.0] 2.5 [− 0.9; 11.7] − 5.52 (− 35.4; 1.1) 0.8
Driving pressure change D0–D7 0.5 [− 3.2; 4.2] 0.5 [− 1.2; 2.2] 0 (− 13.0; 13.0) 1
Driving pressure change D0–D14 1.0 [1.0; 1.0] − 1.5 [− 2.0; 0.2] 2.5 (− 3.0; 3.0) 0.8
D28 mortality 5.0 (26.3%) 4.0 (18.2%) 2.0 (0.5; 8.5) 0.36
  1. Values are expressed as median [interquartile range], or number (%), unless stated otherwise
  2. CI confidence interval, D day, HR hazard ratio, ICU intensive care unit, NA not applicable, PaO2/FiO2 ratio of partial pressure of oxygen to fractional inspired oxygen, PEEP positive end-expiratory pressure, SOFA Sepsis-related Organ-Failure Assessment, UC-MSCs umbilical cord-derived mesenchymal stromal cells
  3. aCensored at day of death for patients having died before D28 and censored at D28 for those patients still in the ICU at D28
  4. bEstimated for the subgroup of patients ventilated at randomization, i.e., 31 patients (11 in CSM-CO group and 20 in placebo group). At Day 28, 6 had died (and censored at time of death), 17 were weaned, and 8 were alive and not weaned yet (censored at D28)