Table 1.
Patient Characteristics and clinical, inflammatory, and virological Results.
| Arm |
||||||||
|---|---|---|---|---|---|---|---|---|
| Day 21 Difference |
||||||||
| Level | Nitazoxanide | Placebo | Rate Ratio | p-Value | Rate Ratio | p-Value | ||
| Number | 25 | 25 | ||||||
| Gender (%) | Masculine | 7 (28) | 8 (32) | 1143 | ||||
| Feminine | 18 (72) | 17 (68) | 0,944 | |||||
| Race (%) | White | 21 (42) | 16 (32) | 0,762 | ||||
| Mixed | 3 (6) | 7 (14) | 2333 | |||||
| Black | 1 (2) | 2 (4) | 2000 | |||||
| Median Age (median (IQR)) | 64 (17) | 64 (21) | 1000 | |||||
| Age Group (%) | less than 65 | 14 (28) | 13 (26) | 0,929 | ||||
| 65 and older | 11 (22) | 12 (24) | 1091 | |||||
| Height (mean (sd)) | 1.71 (0.08) | 1.68 (0.1) | 0,982 | |||||
| Weight (mean (sd)) | 89.2 (17) | 76.18 (13.04) | 0,854 | |||||
| BMI (mean (sd)) | 30.41 (4.12) | 27.06 (3.7) | 0,890 | |||||
| Day of Release (mean (sd)) | 6.16 (4.07) | 9.12 (4.33) | 1481 | 0,021 | ||||
| Severity of the disease scale score (mean (sd)) | 1.7 (0.8) | 2.13 (1.03) | 1253 | 0,001 | ||||
| Viral Load at Day 1 (mean(sd)) | 29.03 (4.84) | 28.88 (4.89) | 0,995 | 0,984 | ||||
| RT-PCR Difference Day 1 - 21 (mean (sd)) | −30.15 (4.50) | −22.17 (12.67) | 0,735 | 0,035 | ||||
| Removed from Supplemental O2 (mean (sd)) | 3.72 (3.29) | 5.88 (4.14) | 1580 | 0,082 | ||||
| O2 Saturation at Day 1 (Oximeter) (mean(sd)) | 93.00 (1.68) | 93.80 (1.94) | 1009 | 0,984 | ||||
| Patients Hospitalized (#) | Day 4 | 12 | 16 | 1481 | 0,300 | |||
| Day 7 | 5 | 10 | 2222 | 0,134 | ||||
| Day 14 | 2 | 5 | 2778 | 0,202 | ||||
| Day 21 | 1 | 2 | 2222 | 0,503 | ||||
| Oxygen supplementation (#) | Day 4 | 8 | 10 | 1389 | 0,487 | |||
| Day 7 | 5 | 6 | 1333 | 0,634 | ||||
| Day 14 | 2 | 3 | 1667 | 0,572 | ||||
| Day 21 | 1 | 2 | 2222 | 0,503 | ||||
| Invasive mechanical ventilation | Day 4 | 1 | 3 | 3333 | 0,268 | |||
| Day 7 | 1 | 4 | 4444 | 0,144 | ||||
| Day 14 | 1 | 1 | 1111 | 0,941 | ||||
| Day 21 | 0 | 0 | ||||||
| Death | Day 7 | 2 | 3 | 2000 | 0,564 | |||
| Day 14 | 0 | 2 | NA | 0,157 | ||||
| Day 21 | 0 | 1 | 2000 | 0,564 | ||||
| Lymphocytes (mean(sd)) | Day 1 | 1029.36 (526.66) | 944.88 (619.43) | |||||
| Day 7 | 1162.36 (689.14) | 1188.57 (615.77 | ||||||
| D-Dimer (mean (sd)) | Day 1 | 1.15 (1.66) | 1.71 (1.83) | |||||
| Day 10 | 1.16 (1.67) | 1.65 (1.79) | ||||||
| Day 21 | 1.18 (1.71) | 1.82 (1.96) | 0.026€ | 1943 | 0,001 | |||
| US- C Reactive Protein (mean (sd)) | Day 1 | 47.11 (70.51) | 96.23 (110.43) | |||||
| Day 10 | 46.33 (70.56) | 87.85 (106.53) | ||||||
| Day 21 | 45.35 (71.26) | 88.13 (101.72) | <0.001€ | 1544 | 0,002 | |||
| TNF-α (MFI (sd)) | Day 1 | 155.54 (53.46) | 196.17 (62.97) | |||||
| Day 10 | 126.06 (33.76) | 167.69 (132.92) | ||||||
| Day 21 | 136.17 (38.38) | 149.12 (45.88) | <0.001€ | 1095 | 0,038 | |||
| IL-6 (MFI (sd)) | Day 1 | 571.19 (557.70) | 1024.55 (1242.96) | |||||
| Day 10 | 323.14 (685.86) | 943.60 (1395.63) | ||||||
| Day 21 | 114.19 (61.02) | 412.86 (407.52) | <0.001€ | 3616 | <0.001 | |||
| IL-8 (MFI (sd)) | Day 1 | 291.72 (145.17) | 205.88 (167.34) | |||||
| Day 10 | 196.65 (85.82) | 164.25 (56.53) | ||||||
| Day 21 | 180.06 (72.12) | 250.57 (133.17) | <0.001€ | 1392 | 0,014 | |||
Ratio: numbers above 1.0 wt toward the Placebo arm. p-value: non-parametric, Wilcoxon test. Sd = standard deviation.
€
= Evolution p-value. MFI = Media Intensity Fluorescence.