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Early use of nitazoxanide in mild Covid-19 disease: randomised, placebo-controlled trial

European Respiratory Journal, 2021, Vol.57 (1), p.2003725 [Peer Reviewed Journal]

Copyright ©ERS 2020. ;2020. This work is licensed under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;2021. This work is licensed under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Copyright ©ERS 2021 2021 ;ISSN: 0903-1936 ;EISSN: 1399-3003 ;DOI: 10.1183/13993003.03725-2020 ;PMID: 33361100

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Title:
Early use of nitazoxanide in mild Covid-19 disease: randomised, placebo-controlled trial
Author: Rocco, Patricia R M ; Silva, Pedro L ; Cruz, Fernanda F ; Junior, Marco Antonio C M ; Tierno, Paulo F G M M ; Moura, Marcos A ; De Oliveira, Luís Frederico G ; Lima, Cristiano C ; Dos Santos, Ezequiel A ; Junior, Walter F ; Fernandes, Ana Paula S M ; Franchini, Kleber G ; Magri, Erick ; de Moraes, Nara F ; Gonçalves, José Mário J ; Carbonieri, Melanie N ; Dos Santos, Ivonise S ; Paes, Natália F ; Maciel, Paula V M ; Rocha, Raissa P ; de Carvalho, Alex F ; Alves, Pedro Augusto ; Modena, José Luiz P ; Cordeiro, Artur T ; Trivella, Daniela B B ; Marques, Rafael E ; Luiz, Ronir R ; Pelosi, Paolo ; Lapa E Silva, Jose Roberto
Subjects: Original s
Is Part Of: European Respiratory Journal, 2021, Vol.57 (1), p.2003725
Description: Nitazoxanide is widely available and exerts broad-spectrum antiviral activity However, there is no evidence of its impact on SARS-CoV-2 infection.In a multicenter, randomised, double-blind, placebo-controlled trial, adult patients presenting up to 3 days after onset of Covid-19 symptoms (dry cough, fever, and/or fatigue) were enrolled. After confirmation of SARS-CoV2 infection by RT-PCR on a nasopharyngeal swab, patients were randomised 1:1 to receive either nitazoxanide (500 mg) or placebo, TID, 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.From June 8 to August 20, 2020, 1575 patients were screened. Of these, 392 (198 placebo, 194 nitazoxanide) were analysed. Median 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 18.2% in the placebo arm (p=0.009). Viral load was also reduced after nitazoxanide compared to placebo (p=0.006). The percent 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.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.
Publisher: England: European Respiratory Society Journals Ltd
Language: English
Identifier: ISSN: 0903-1936
EISSN: 1399-3003
DOI: 10.1183/13993003.03725-2020
PMID: 33361100
Source: Coronavirus Research Database

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Early use of nitazoxanide in mild Covid-19 disease: randomised, placebo-controlled trial

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