Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

Frontiers in Medicine

article

Patricia R. M. Rocco¹  Pedro L. Silva¹  Fernanda F. Cruz¹  Paulo F. G. M. M. Tierno²  Eucir Rabello³  Jéfiton Cordeiro Junior⁴  Firmino Haag⁵  Renata E. de Ávila⁶  Joana D. G. da Silva⁷  Mariana M. S. Mamede⁸  Konrad S. Buchele⁹  Luiz C. V. Barbosa^1,10  Anna C. Cabral^1,11  Antônio A. F. Junqueira^1,12  João A. Araújo-Filho^1,13  Lucianna A. T. J. da Costa^1,14  Pedro P. M. Alvarenga^1,15  Alexandre S. Moura^1,16  Ricardo Carajeleascow^1,17  Mirella C. de Oliveira^1,18  Roberta G. F. Silva^1,19  Cynthia R. P. Soares^2,20  Ana Paula S. M. Fernandes^2,21  Flavio Guimarães Fonseca^2,21  Vidyleison Neves Camargos^2,21  Julia de Souza Reis^2,21  Kleber G. Franchini^2,22  Ronir R. Luiz¹  Sirlei Morais^2,23  Carlos Sverdloff^2,23  Camila Marinelli Martins^2,24  Nathane S. Felix¹  Paula Mattos-Silva¹  Caroline M. B. Nogueira¹  Dayene A. F. Caldeira¹  Paolo Pelosi^2,25  José R. Lapa-e-Silva¹ 

[1] Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro;Hospital Municipal de Barueri Dr. Francisco Moran;Hospital da Força Aérea do Galeão;Hospital Regional de Sorocaba Dr. Adib D Jatene- Bata Branca;Hospital Geral de São Mateus – Dr. Manoel Bifulco;Hospital Eduardo Menezes;Hospital Regional da Asa Norte;Hospital das Forças Armadas;Hospital Naval Marcilio Dias;Hospital das Clínicas Luzia de Pinho Melo;Hospital Universitário Pedro Ernesto;Hospital Central da Aeronáutica;Hospital Estadual de Doenças Tropicais Dr. Anuar Auad;Hospital Geral de Fortaleza;Hospital Mater Dei;Santa Casa de Misericórdia de Belo Horizonte;Complexo Hospitalar Municipal de São Caetano do Sul;Complexo do Trabalhador de Curitiba;Hospital da Força Aérea de São Paulo;Hospital das Clínicas da Universidade Federal do Pernambuco;Centro de Tecnologia de Vacinas, Universidade Federal de Minas Gerais;Brazilian Centre for Research in Energy and Materials;ATCGEN;AAC&T Research Consulting LTDA;Department of Surgical Sciences and Integrated Diagnostics, University of Genoa;Anesthesia and Critical Care, San Martino Policlinico Hospital, Istituto di Ricovero e Cura a Carattere Scientifico ,(IRCCS) for Oncology and Neurosciences

关键词: D-dimer;    oxygenation;    pneumonia;    SARS-CoV-2;    COVID-19;   

DOI  :  10.3389/fmed.2022.844728

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

CC BY