Table 2.
Primary Outcome | Prophylaxis Dose Tinzaparin 4500 IU/day (N = 106) |
Intermediate Dose Tinzaparin 100 IU/kg/day (N = 91) |
Therapeutic Dose Tinzaparin 175 UI/kg (N = 103) |
Absolute Difference (* Intermediate Dose vs. Prophylactic Dose; ** Therapeutic Dose vs. Prophylactic Dose) |
Risk Reduction (* Intermediate Dose vs. Prophylactic Dose; ** Therapeutic Dose vs. Prophylactic Dose) |
p-Value |
---|---|---|---|---|---|---|
Primary endpoint (day + 30). N (%) |
19 (17.9) | 20 (22.0) | 19 (18.4) | * 1 ** 0 |
* −4.0 (−7.2%, −15.3%) ** 0.5 (−9.9%, 10.9%) |
0.769 1 |
Secondary outcomes | ||||||
Death from any cause N (%) |
2 (1.9) | 3 (3.3) | 2 (1.9) | * 1 ** 0 |
* 1.4% (−3.1%, 5.9%) ** 0.05% (−3.7%, 3.8%) |
0.79 2 |
Thrombotic event N (%) |
4 (3.8) | 2 (2.2) | 2 (1.9) | * 2 ** 2 |
* 1.6% (−3.1%, 6.3%) ** 1.9% (−2.5%, 6.3%) |
0.74 2 |
ICU admission N (%) |
7 (6.6) | 6 (6.6) | 10 (9.7) | * 1 ** 3 |
* 0.01% (−6.9%, 6.9%) ** −3.1% (−4.3%, 10.5%) |
0.63 1 |
High flow nasal cannula N (%) |
13 (12.3) | 14 (15.4) | 13 (12.6) | * 1 ** 0 |
* −3.1% (−6.6%, 12.8%) ** 0.4% (−8.6%, 9.3%) |
0.78 1 |
Non invasive mechanical ventilation N (%) |
4 (3.8) | 4 (4.4) | 2 (1.9) | * 0 ** 2 |
* −0.6% (−4.9%, 6.2%) ** 1.8% (−2.7%, 6.3%) |
0.67 2 |
Invasive ventilation N (%) |
1 (0.9) | 2 (2.2) | 3 (2.9) | * 1 ** 2 |
* −1.2% (−2.3%, 4.8%) ** −1.9% (−1.8%, 5.7%) |
0.60 2 |
Progression WHO * scale, Median (Q1; Q3) | −0.43 (−1; 0) | 0.13 (−0.5; 1) | 0.06 (0; 1) | - | - | 0.69 3 |
Progression to adult respiratory distress syndrome by PaO2/FiO2 or SpO2/FiO2. N (%) | 4 (3.8) | 2 (2.2) | 1 (1.0) | - | - | 0.40 2 |
Length of hospital stay, Median (Q1; Q3) | 10.0 (6.0; 17.0) | 9.5 (6.0; 24.0) | 11.0 (6.0; 14.0) | - | - | 0.96 4 |
Major bleeding N (%) |
- | - | - | - | - | - |
Clinically relevant non major bleeding, N (%) | 4 (3.8) | 3 (3.3) | 3 (2.9) | * 1 ** 1 |
* 0.5% (−4.7%, 5.6%) ** 0.9% (−4.0%, 5.7%) |
1.00 2 |
* Primary endpoint was composite outcome of death, intensive care unit admission, need for mechanical ventilation (invasive or noninvasive or high-flow therapy via nasal cannula), and venous or arterial thrombosis within 30 days after randomization. Secondary outcomes were measured at 90 days after randomization. 1 Chi-square test p-value. 2 Fisher’s exact test p-value. 3 Wilcoxon’s test p-value. 4 Kruskal–Wallis’ test p-value. ** Therapeutic Dose vs. Prophylactic.