COVID NT-300
Trial question
What is the role of nitazoxanide in outpatients with mild to moderate COVID-19?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 379
379 patients (214 female, 165 male).
Inclusion criteria: patients presenting within 72-hour onset of mild or moderate COVID-19.
Key exclusion criteria: signs or symptoms suggestive of severe COVID-19 including resting respiratory rate ≥ 30 breaths/min, resting pulse rate ≥ 125 beats/min, or blood oxygen saturation ≤ 93%; previous COVID-19 infection; immunodeficiency.
Interventions
N=184 nitazoxanide (600 mg PO BID for 5 days).
N=195 placebo (matching placebo tablets PO BID for 5 days).
Primary outcome
Time to sustained clinical recovery
13.3 days
12.4 days
13.3 days
10.0 days
6.7 days
3.3 days
0.0 days
Nitazoxanide
Placebo
No significant
difference ↔
No significant difference in time to sustained clinical recovery (13.3 days vs. 12.4 days; AD 0.9 days, 95% CI -9.93 to 11.73).
Secondary outcomes
No significant difference in patients who progressed to severe COVID-19 (0.5% vs. 3.6%; OR 5.6, 95% CI 0.7 to 46.1).
No significant difference in composite outcome of hospitalization, emergency room visit, or death at 28 days (0.5% vs. 3.1%; OR 4.7, 95% CI 0.6 to 39.7).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients presenting within 72-hour onset of mild or moderate COVID-19, nitazoxanide was not superior to placebo with respect to time to sustained clinical recovery.
Reference
Jean-François Rossignol, Matthew C Bardin, Jessica Fulgencio et al. A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19. EClinicalMedicine. 2022 Feb 28;45:101310.
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