TY - JOUR T1 - Early use of nitazoxanide in mild Covid-19 disease: randomised, placebo-controlled trial JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.03725-2020 SP - 2003725 AU - Patricia R. M. Rocco AU - Pedro L. Silva AU - Fernanda F. Cruz AU - Marco Antonio C. M. Junior AU - Paulo F. G. M. M. Tierno AU - Marcos A. Moura AU - Luís Frederico G. De Oliveira AU - Cristiano C. Lima AU - Ezequiel A. Dos Santos AU - Walter F. Junior AU - Ana Paula S. M. Fernandes AU - Kleber G. Franchini AU - Erick Magri AU - Nara F. de Moraes AU - José Mário J. Gonçalves AU - Melanie N. Carbonieri AU - Ivonise S. Dos Santos AU - Natália F. Paes AU - Paula V. M. Maciel AU - Raissa P. Rocha AU - Alex F. de Carvalho AU - Pedro Augusto Alves AU - José Luiz P. Modena AU - Artur T. Cordeiro AU - Daniela B. B. Trivella AU - Rafael E. Marques AU - Ronir R. Luiz AU - Paolo Pelosi AU - Jose Roberto Lapa e Silva A2 - , Y1 - 2020/01/01 UR - http://erj.ersjournals.com/content/early/2021/01/04/13993003.03725-2020.abstract N2 - Nitazoxanide 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.This was the first study to evaluate the effect of early nitazoxanide therapy in mild Covid-19. Nitazoxanide did not accelerate symptom resolution after 5 days of therapy but did reduce viral load significantly with no serious adverse events. ER -