Table 2.
Clinical and Disease-related Characteristics at Baseline
| Parameter | NTZ + SOC (n = 130) | Placebo + SOC (n = 127) | Total (N = 257) | P Valuea |
|---|---|---|---|---|
| Presence of symptoms | ||||
| Cough | 71 (54.6) | 75 (59.1) | 146 (56.8) | .43 |
| Fatigue | 60 (46.2) | 54 (42.5) | 114 (44.4) | .60 |
| Difficulty breathing | 54 (41.5) | 51 (40.2) | 105 (40.9) | .86 |
| Nasal discharge | 40 (30.8) | 25 (19.7) | 65 (25.3) | .045 |
| Sore throat | 29 (22.3) | 23 (18.1) | 52 (20.2) | .40 |
| Muscle pain | 28 (21.5) | 18 (14.2) | 46 (17.9) | .12 |
| Headache | 21 (16.2) | 13 (10.2) | 34 (13.2) | .16 |
| Nausea | 4 (3.1) | 8 (6.3) | 12 (4.7) | .22 |
| Vomiting | 5 (3.9) | 7 (5.6) | 12 (4.7) | .52 |
| Diarrhea | 4 (3.1) | 5 (3.9) | 9 (3.5) | .70 |
| Children | (n = 67) | (n = 64) | (n = 131) | |
| Cough | 41 (61.2) | 44 (68.8) | 85 (64.9) | .37 |
| Sore throat | 16 (23.9) | 14 (21.9) | 30 (22.9) | .75 |
| Fatigue | 30 (44.8) | 25 (39.1) | 55 (42.0) | .51 |
| Nasal discharge | 27 (40.3) | 15 (23.4) | 42 (32.1) | .04 |
| Difficulty breathing | 25 (37.3) | 27 (42.2) | 52 (39.7) | .57 |
| Headache | 10 (14.9) | 2 (3.1) | 12 (9.2) | .02 |
| Muscle pain | 11 (16.4) | 5 (7.8) | 16 (12.2) | .12 |
| Nausea | 3 (4.5) | 5 (7.8) | 8 (6.1) | .43 |
| Vomiting | 3 (4.5) | 4 (6.3) | 7 (5.3) | .65 |
| Diarrhea | 2 (3.0) | 2 (3.1) | 4 (3.1) | .96 |
| Adults | (n = 63) | (n = 63) | (n = 126) | |
| Cough | 30 (47.6) | 31 (49.2) | 61 (48.4) | .79 |
| Sore throat | 13 (20.6) | 9 (14.3) | 22 (17.5) | .37 |
| Fatigue | 30 (47.6) | 29 (46.0) | 59 (46.8) | .92 |
| Nasal discharge | 13 (20.6) | 10 (15.9) | 23 (18.3) | .51 |
| Difficulty breathing | 29 (46.0) | 24 (38.1) | 53 (42.1) | .40 |
| Headache | 11 (17.5) | 11 (17.5) | 22 (17.5) | .97 |
| Muscle pain | 17 (27.0) | 13 (20.6) | 30 (23.8) | .43 |
| Nausea | 1 (1.6) | 3 (4.8) | 4 (3.2) | .30 |
| Vomiting | 2 (3.2) | 3 (4.8) | 5 (4.0) | .63 |
| Diarrhea | 2 (3.2) | 3 (4.8) | 5 (4.0) | .63 |
| Scores | ||||
| Oxygen saturationb, median (IQR) | 89.0 (85.0–92.0) | 89.0 (88.6–92.0) | 89.0 (85.0–92.0) | .86c |
| SOFA score, median (IQR) | 0.0 (0.0–7.0) | 0.0 (0.0–6.0) | 0.0 (0.0–7.0) | .82c |
| Tal bronchitis score (<24 mo old), median (IQR) | 2.0 (1.0–3.0) | 2.0 (1.0–3.0) | 2.0 (1.0–3.0) | .86c |
| Charlson comorbidity index, median (IQR) | 0.0 (0.0–1.5) | 0.0 (0.0–2.0) | 0.0 (0.0–2.0) | .12c |
| Chronic oxygen use | 7 (5.4) | 6 (4.7) | 13 (5.1) | .79 |
| Supplemental oxygen required | 119 (91.5) | 118 (92.9) | 237 (92.2) | .68 |
| ICU admission required | 3 (2.3) | 2 (1.6) | 5 (2.0) | .67 |
| Presence of complications | ||||
| Pneumonia | 74 (56.9) | 73 (57.5) | 147 (57.2) | .93 |
| Respiratory failure requiring mechanical ventilation | 0 (0.0) | 0 (0.0) | 0 (0.0) | … |
| ARDS | 6 (4.6) | 6 (4.7) | 12 (4.7) | .97 |
| Sepsis | 0 (0.0) | 0 (0.0) | 0 (0.0) | … |
| Bronchitis | 2 (1.5) | 7 (5.5) | 9 (3.5) | .08 |
| Global assessment | ||||
| Participants ≥18 y old | ||||
| Felt as good as before illness? (yes) | 12 (19.1) | 11 (17.5) | 23 (18.3) | .85 |
| Functioning as well as before illness? (yes) | 10 (15.9) | 6 (9.5) | 16 (12.7) | .30 |
| Participants <18 y old | ||||
| Is child as active as before illness? (yes) | 6 (9.0) | 12 (18.8) | 18 (13.7) | .10 |
| Is the child eating as much as before illness? (yes) | 10 (14.9) | 12 (18.8) | 22 (16.8) | .56 |
Data are presented as no. (%) unless otherwise indicated.
Abbreviations: ARDS, acute respiratory distress syndrome; ICU, intensive care unit; IQR, interquartile range; NTZ, nitazoxanide; SARI, severe acute respiratory illness; SOC, standard of care; SOFA, Sequential Organ Failure Assessment.
aTest of proportions for binary endpoints unless otherwise noted.
bNormal oxygen saturation in Mexico City is 95%–99% per Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán hospital reference ranges but has been reported as a median of 91% in the literature [21].
cTest of means for continuous variables.