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

dc.creatorRocco, Patricia R. M.
dc.creatorSilva, Pedro L.
dc.creatorCruz, Fernanda F.
dc.creatorM. Junior, Marco Antonio C.
dc.creatorTierno, Paulo F. G. M. M.
dc.creatorMoura, Marcos A.
dc.creatorOliveira, Luís Frederico G. de
dc.creatorLima, Cristiano C.
dc.creatorSantos, Ezequiel A. dos
dc.creatorF. Junior, Walter
dc.creatorFernandes, Ana Paula S. M.
dc.creatorFranchini, Kleber G.
dc.creatorMagri, Erick
dc.creatorMoraes, Nara F. de
dc.creatorGonçalves, José Mário J.
dc.creatorCarbonieri, Melanie N.
dc.creatorSantos, Ivonise S. dos
dc.creatorPaes, Natália F.
dc.creatorMaciel, Paula V. M.
dc.creatorRocha, Raissa P.
dc.creatorCarvalho, Alex F. de
dc.creatorAlves, Pedro Augusto
dc.creatorModena, José Luiz P.
dc.creatorCordeiro, Artur T.
dc.creatorTrivella, Daniela B. B.
dc.creatorMarques, Rafael E.
dc.creatorLuiz, Ronir R.
dc.creatorPelosi, Paolo
dc.creatorSilva, Jose Roberto Lapa e
dc.date2022-03-17T16:49:55Z
dc.date2022-03-17T16:49:55Z
dc.date2021
dc.date.accessioned2023-09-26T22:29:47Z
dc.date.available2023-09-26T22:29:47Z
dc.identifierROCCO, Patrícia R. M. et al. Early use of nitazoxanide in mild Covid-19 disease: randomised, placebo-controlled trial. The European Respiratory Journal, p. 1-67, 2020.
dc.identifier0903-1936
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/51724
dc.identifier10.1183/13993003.03725-2020
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8879972
dc.descriptionNitazoxanide is widely available and exerts broad-spectrum antiviral activity in vitro. 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 versus 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.
dc.formatapplication/pdf
dc.languageeng
dc.publisherEuropean Respiratory Society
dc.relationhttps://www.arca.fiocruz.br/handle/icict/46293
dc.rightsopen access
dc.subjectSARS-CoV-2
dc.subjectCOVID-19
dc.subjectDrugs
dc.subjectNitazoxanide
dc.titleEarly use of nitazoxanide in mild Covid-19 disease: randomised, placebo-controlled trial
dc.typeArticle


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