Details

Autor(en) / Beteiligte

• 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

Titel

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

Ist Teil von

• The European respiratory journal, 2021, Vol.58 (1), p.2003725

Ort / Verlag

England: European Respiratory Society

Erscheinungsjahr

2021

Quelle

EZB Free E-Journals

Beschreibungen/Notizen

• 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.