Table 3.
Within-group and between-group hanges observed in Cohort 2.
| Endpoint per group | Day | Difference median* (95% CI) | Significant change in LCLT group (p value) | Significant change in Placebo group (p value) | LCLT vs. Placebo significant difference (p value) |
|---|---|---|---|---|---|
| Platelets (μL.10−3) in total group (n = 122) | 1 vs. 7 | 11.5 (7.0; 20.5) | Yes (0.009) | No (0.16) | No (0.56) |
| 1 vs. 14 | 7.5 (−1.5; 13.5) | No (0.33) | No (0.35) | No (0.71) | |
| 1 vs. 21 | 3.0 (−2.5; 11.0) | No (0.69) | No (0.91) | No (0.62) | |
| Platelets (μL.10−3) in subgroup (n = 23) | 1 vs. 7 | 91.0 (53.5; 141) | Yes (0.006) | Yes (0.018) | No (0.71) |
| 1 vs. 14 | 101.0 (41.5; 163.5) | Yes (0.018) | Yes (0.013) | No (0.68) | |
| 1 vs. 21 | 33.0 (10; 67.5) | No (0.23) | No (0.083) | No (0.54) | |
| Fibrinogen (mg/dL) in total group (n = 122) | 1 vs. 7 | −8.0 (−19.5; −3.5) | No (0.091) | No (0.072) | No (0.95) |
| 1 vs. 14 | −19.0 (−31.5; −11.5) | Yes (0.003) | Yes (0.048) | No (0.22) | |
| 1 vs. 21 | −20.5 (−34.5; −13.5) | Yes (0.001) | No (0.057) | No (0.30) | |
| Fibrinogen (mg/dL) in subgroup (n = 23) | 1 vs. 7 | −3.5 (−51.0; 57.5) | No (0.88) | No (0.88) | No (0.79) |
| 1 vs. 14 | −39.5 (−110.5; 10.0) | Yes (0.038) | No (0.83) | No (0.13) | |
| 1 vs. 21 | −47.0 (−96.0; −9.5) | No (0.12) | No (0.83) | No (0.36) | |
| ACE1 (ng/mL) in total group (n = 122) | 1 vs. 21 | 24.9 (19.6; 41.9) | Yes (0.029) | No (0.012) | Yes (0.009) |
| ACE1 (ng/mL) in subgroup (n = 23) | 1 vs. 21 | 18.0 (10.5; 47.0) | Yes (0.188) | No (0.846) | No (0.257) |
| CRP (mg/dL) in total group (n = 122) | 1 vs. 7 | −0.035 (−0.290; −0.015) | No (0.74) | No (0.12) | No (0.77) |
| 1 vs. 14 | 0.000 (−0.275; 0.020) | No (0.61) | No (0.29) | No (0.48) | |
| 1 vs. 21 | −0.010 (−0.335; 0.055) | No (0.30) | No (0.55) | No (0.47) | |
| CRP (mg/dL) in subgroup (n = 23) | 1 vs. 7 | −0.020 (−3.950; 0.665) | No (0.91) | No (0.75) | No (0.63) |
| 1 vs. 14 | −0.380 (−6.175; −0.115) | No (0.20) | No (0.96) | No (0.21) | |
| 1 vs. 21 | −0.160 (−6.185; −0.035) | No (0.17) | No (0.60) | No (0.47) |
*
The “Difference Median” column refers to the median of the observed differences between the values of the subjects’ biomarkers at a given date and the baseline (e.g., the median of the observed differences between the platelet count on days D14 and D01).
The 95% confidence intervals were calculated using the Wilcoxon signed rank statistic. Total group = 122 patients; Subgroup = 23 patients with progression of the infection (CT Scan); LCLT, L carnitine L-tartrate.