Nitazoxanide in patients hospitalized with COVID-19 pneumonia: a multicentre, randomized, double-blind, placebo-controlled trial
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2022
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Background: Nitazoxanide exerts antiviral activity in vitro and in vivo and
anti-inflammatory effects, but its impact on patients hospitalized with COVID-19
pneumonia is uncertain.
Methods: A multicentre, randomized, double-blind, placebo-controlled trial was
conducted in 19 hospitals in Brazil. Hospitalized adult patients requiring supplemental
oxygen, with COVID-19 symptoms and a chest computed tomography scan
suggestive of viral pneumonia or positive RT-PCR test for COVID-19 were
enrolled. Patients were randomized 1:1 to receive nitazoxanide (500 mg) or
placebo, 3 times daily, for 5 days, and were followed for 14 days. The
primary outcome was intensive care unit admission due to the need for invasive
mechanical ventilation. Secondary outcomes included clinical improvement, hospital
discharge, oxygen requirements, death, and adverse events within 14 days Results: Of the 498 patients, 405 (202 in the nitazoxanide group and 203 in the
placebo group) were included in the analyses. Admission to the intensive care unit did not
differ between the groups (hazard ratio [95% confidence interval], 0.68 [0.38–1.20], p =
0.179); death rates also did not differ. Nitazoxanide improved the clinical outcome (2.75
[2.21–3.43], p < 0.0001), time to hospital discharge (1.37 [1.11–1.71], p = 0.005), and
reduced oxygen requirements (0.77 [0.64–0.94], p = 0.011). C-reactive protein, D-dimer,
and ferritin levels were lower in the nitazoxanide group than the placebo group on day 7.
No serious adverse events were observed.
Conclusions: Nitazoxanide, compared with placebo, did not prevent admission to the
intensive care unit for patients hospitalized with COVID-19 pneumonia.
Clinical Trial Registration: Brazilian Registry of Clinical Trials (REBEC) RBR88bs9x;
ClinicalTrials.gov, NCT04561219.
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D-dimer, Oxygenation, Pneumonia, SARS-CoV-2, COVID-19
Citação
ROCCO, Patricia R. M. et. al. Nitazoxanide in patients hospitalized with COVID-19 pneumonia: a multicentre, randomized, double-blind, placebo-controlled trial. Frontiers in Medicine, Lausanne, v. 9, e844728, 2022. DOI: 10.3389/fmed.2022.844728. Disponível em: https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.844728/full. Acesso em: 17 jan. 2025.