Current best evidence for clinical care (more info)
BACKGROUND: Nitazoxanide is widely available and exerts broad-spectrum antiviral activity in vitro. However, there is no evidence of its impact on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
METHODS: In a multicentre, randomised, double-blind, placebo-controlled trial, adult patients presenting up to 3 days after onset of coronavirus disease 2019 (COVID-19) symptoms (dry cough, fever and/or fatigue) were enrolled. After confirmation of SARS-CoV-2 infection using reverse transcriptase PCR on a nasopharyngeal swab, patients were randomised 1:1 to receive either nitazoxanide (500 mg) or placebo, three times daily, for 5 days. The primary outcome was complete resolution of symptoms. Secondary outcomes were viral load, laboratory tests, serum biomarkers of inflammation and hospitalisation rate. Adverse events were also assessed.
RESULTS: From June 8 to August 20, 2020, 1575 patients were screened. Of these, 392 (198 placebo, 194 nitazoxanide) were analysed. Median (interquartile range) time from symptom onset to first dose of study drug was 5 (4-5) days. At the 5-day study visit, symptom resolution did not differ between the nitazoxanide and placebo arms. Swabs collected were negative for SARS-CoV-2 in 29.9% of patients in the nitazoxanide arm versus 18.2% in the placebo arm (p=0.009). Viral load was reduced after nitazoxanide compared to placebo (p=0.006). The percentage viral load reduction from onset to end of therapy was higher with nitazoxanide (55%) than placebo (45%) (p=0.013). Other secondary outcomes were not significantly different. No serious adverse events were observed.
CONCLUSIONS: In patients with mild COVID-19, symptom resolution did not differ between nitazoxanide and placebo groups after 5 days of therapy. However, early nitazoxanide therapy was safe and reduced viral load significantly.
| Discipline / Specialty Area | Score |
|---|---|
| Emergency Medicine | |
| General Internal Medicine-Primary Care(US) | |
| Family Medicine (FM)/General Practice (GP) | |
This moderate sized randomized trial with a significant number of patients lost to follow up failed to find any hint of clinical benefit with nitazoxanide for COVID-19 patients. Small decreases in viral load compared to placebo are likely clinically meaningless. This is a another fail at identifying a breakthrough treatment for COVID-19.
This is useful information for every physician working at COVID-19 clinics.
If this was being purported widespread as a treatment, it may be newsworthy. However, with lack of a seeming clinically important outcome and lack of intention to treat analysis, I don't see this as specifically newsworthy unless these results are noted as a review of current treatment possibilities that have been studied.