Characteristics of the Participants Testing Positive for SARS-CoV-2 on RT-PCR at Baseline
| Nitazoxanide (n=194) | Placebo (n=198) | p value | |
| Age range, n (%) | 0.891 | ||
| 18 to 39 years | 115 (59) | 113 (57) | |
| 40 to 59 years | 68 (35) | 74 (37) | |
| 60 to 77 years | 11 (6) | 11 (6) | |
| Sex, n (%) | 0.054 | ||
| Men | 101 (52) | 83 (42) | |
| Women | 93 (48) | 115 (58) | |
| Ethnicity, n (%) | 0.644 | ||
| White | 131 (68) | 138 (70) | |
| Asian | 5 (3) | 2 (1) | |
| Indigenous Brazilian | 0 (0) | 1 (0.5) | |
| Black | 31 (16) | 32 (16) | |
| Mixed | 27 (14) | 24 (12) | |
| BMI (kg/m2), n (%) | 1.000 | ||
| <29.9 | 134 (69) | 136 (69) | |
| ≥30.0 | 60 (31) | 62 (31) | |
| Comorbidities, n (%) | 0.091 | ||
| No | 171 (88) | 162 (82) | |
| Yes# | 23 (12) | 36 (18) | |
| Time from onset of symptoms to enrollment, n (%) | 0.241 | ||
| 1 day | 14 (7) | 18 (9) | |
| 2 days | 42 (22) | 55 (28) | |
| 3 days | 138 (71) | 125 (63) | |
| Time from onset of symptoms to the first dose of nitazoxanide or placebo, median (IQR), days | 5 (4–5) | 5 (4–5) | 0.124 |
| Concomitant medications, n (%) | |||
| None | 154 (80) | 158 (80) | 1.000 |
| Angiotensin-II receptor antagonists | 6 (3) | 12 (6) | 0.227 |
| Angiotensin-conversing enzyme inhibitors | 1 (1) | 1 (0.5) | 0.833 |
| Metformin | 1 (0.5) | 4 (2) | 0.372 |
| Statins | 0 (0) | 4 (2) | 0.123 |
| Symptoms at baseline, n (%) | |||
| Inclusion criteria | |||
| Dry cough | 141 (73) | 148 (75) | 0.574 |
| Fever | 109 (56) | 115 (58) | 0.760 |
| Fatigue | 95 (49) | 95 (48) | 0.920 |
| Secondary symptoms | |||
| Sore throat | 82 (42) | 68 (34) | 0.119 |
| Myalgia | 60 (31) | 53 (27) | 0.374 |
| Headache | 64 (33) | 81 (41) | 0.117 |
| Anosmia | 17 (9) | 18 (9) | 1.000 |
| Ageusia | 20 (10) | 17 (9) | 0.607 |
| Diarrhea | 14 (7) | 5 (3) | 0.035 |
| Nasopharyngeal swab RT-PCR viral load (Log10 copies/mL), median (IQR) | 7.06 (5.77–8.13) | 7.49 (6.15–8.32) | 0.065 |
| SpO2, mean (sd) | 97.3 (1.4) | 97.4 (1.3) | 0.835 |
| WBC (x103/mL), median (IQR) | 5.4 (4.3–6.6) | 5.3 (4.6–6.5) | 0.904 |
| Neutrophils (x103/mL), median (IQR) | 2.8 (2.1–3.9) | 2.9 (2.2–4.0) | 0.984 |
| Lymphocytes (x103/mL), median (IQR) | 1.9 (1.5–2.2) | 1.8 (1.4–2.4) | 0.423 |
| Platelets (x103/mL), median (IQR) | 245 (205–245) | 213 (177–257) | 0.243 |
| CRP (mg/L), median (IQR) | 6.0 (2.0–15.0) | 4.5 (2.0–12.2) | 0.190 |
| Cytokine concentration (pg/dL), median (IQR) | |||
| IL-6 | 0 (0–4.10) | 0 (0–8.34) | 0.471 |
| IL-8 | 2.79 (0–12.48) | 5.51 (0.38–17.91) | 0.090 |
| IL-1β | 0 (0–0) | 0 (0–19.45) | 0.088 |
| TNF-α | 0 (0–0) | 0 (0–0) | 0.179 |
| IFN-γ | 0 (0–16.24) | 0 (0–10.24) | 0.526 |
BMI: body mass index; CRP: C-reactive protein; IFN: interferon; IL: interleukin; IQR: interquartile range; sd: standard deviation; SpO2: peripheral oxyhemoglobin saturation; TNF: tumor necrosis factor. Interferon WBC: white blood cells.
#systemic arterial hypertension, diabetes mellitus, asthma. No significant differences were observed between the two groups.