Table 1.
Blinded, placebo-controlled, randomized clinical trials evaluating the efficacy and safety of nitazoxanide in treating COVID-19
| Author | Country | Design (protocol/phase) | Setting | Population | Intervention | Control | Outcomes of interest and follow-up period |
|---|---|---|---|---|---|---|---|
| Rocco et al. [23] | Brazil | Double-blinded, placebo-controlled trial (NCT04561219/Phase 2) | 19 hospitals | Patients with COVID-19 requiring supplemental oxygen (median age 56 years; 39% female) | NTZ 500 mg TID for 5 days (n = 202) |
Placebo (n = 203) |
Viral load and RT-PCR status (day 7), serum biomarkers of inflammation (day 7), ICU (day 14), mortality (day 14), and any adverse events |
| Rocco et al. [25] | Brazil | Double-blinded, placebo-controlled trial (NCT04552483/Phase 2) | Five freestanding urgent care centres and two hospitals | Patients with mild COVID-19 (94.4% less than 60 years old; 53.1% female) | NTZ 500 mg TID for 5 days (n = 194) |
Placebo (n = 198) |
Viral load, RT-PCR status, serum biomarkers of inflammation, ICU, mortality, and any adverse events. All outcomes were evaluated after 5 days of therapy |
| Blum et al. [27] | Brazil | Double-blinded, placebo-controlled trial (NCT04348409/Phase 2) | Six hospitals | Patients with mild COVID-19 (median age 64 years; 70% female) | NTZ 600 mg BID for 7 days (n = 25) |
Placebo (n = 25) |
RT-PCR status, serum biomarkers of inflammation, mortality, and any adverse events. All outcomes were evaluated after 21 days of therapy |
| Rossignol et al. [24] | USA and Puerto Rico | Double-blinded, placebo-controlled trial (NCT04486313/Phase 3) | 36 outpatient medical clinics | Patients with mild or moderate COVID-19 (median age 40 year; 56.5% female) | NTZ 600 mg BID for 5 days (n = 184) |
Placebo (n = 195) |
Viral load and RT-PCR status (day 10), mortality (day 28), and any adverse events |
| Silva et al. [26] | Argentina | Single-blinded, placebo-controlled trial (NCT04463264/Phase 2–3) | Two hospitals | Patients with mild or moderate COVID-19 (age range 19–68 years; 27.8% female) |
NTZ 500 mg, 4 × per day for 14 days (n = 23) |
Placebo (n = 13) |
Viral load, RT-PCR status, mortality, and gastrointestinal adverse events. All outcomes were evaluated after 7 days of therapy |
NTZ nitazoxanide