Efficacy and safety of nitazoxanide in treating SARS-CoV-2 infection. A
rapid and living systematic review and meta-analysis of blinded,
placebo-controlled, randomized clinical trials.
Abstract
Introduction Nitazoxanide is a broad-spectrum antiparasitic that has
been tested for COVID-19 due to the anti-inflammatory effects and in
vitro anti-viral activity and promising clinical benefits against
influenza and other viruses. The aim of this study was to synthesize the
best evidence on the efficacy and safety of nitazoxanide as treatment
for patients with COVID-19. Methods Searches for studies were performed
in peer-reviewed and gray literature. The following elements were used
to define eligibility criteria: (1) Population, individuals with
laboratory-confirmed SARS-CoV-2 infection; (2) Intervention,
nitazoxanide; (3) Comparison, placebo; (4) Outcomes: positive RT-PCR
status, composite measure of disease progression (severe COVID-19, ICU
admission or invasive mechanical ventilation), death, serum biomarkers
of inflammation (C-reactive protein, IL-6, and IL-8), and any adverse
events; (5) Study type: blinded, placebo-controlled, randomized clinical
trials (RCT). Treatment effects were reported as relative risk (RR) and
mean difference (MD) with 95% confidence intervals (CI). Results Four
blinded, placebo-controlled RCT were included in the meta-analysis and
enrolled individuals with mild or moderate SARS-CoV-2 infection. We
found no difference between nitazoxanide and placebo in the frequency of
positive RTP-PCR results (RR = 0.83; 95% CI 0.58 to 1.17) and there was
no decreased risk for disease progression (severe COVID-19, ICU
admission or invasive mechanical ventilation) (RR = 0.40; 95% CI 0.08
to 2.13) and deaths (RR = 0.55; 95% CI 0.18 to 1.68) among patients
receiving nitazoxanide. There were no differences for patients treated
with nitazoxanide and placebo in the levels of inflammatory markers.
Conclusions In this study, we found no current evidence from blinded,
placebo-controlled, RCT on the efficacy of nitazoxanide in treating
patients with COVID-19. This living systematic review should be updated
as soon as the results of ongoing RCT are published.