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

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

Rocco et al., Frontiers in Medicine, doi:10.3389/fmed.2022.844728, NCT04561219 (history)

Rocco et al., Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind,.., Frontiers in Medicine, doi:10.3389/fmed.2022.844728, NCT04561219

Apr 2022 Source PDF

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RCT late stage patients with COVID-19 pneumonia, 202 treated with nitazoxanide and 203 placebo patients, showing improved recovery, but no significant difference in mortality.

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risk of death, 4.9% higher, RR 1.05, p = 0.94, treatment 6 of 202 (3.0%), control 5 of 203 (2.5%), adjusted per study, odds ratio converted to relative risk, multivariable, day 14.

risk of ICU admission, 30.5% lower, RR 0.69, p = 0.18, treatment 20 of 202 (9.9%), control 30 of 203 (14.8%), NNT 21, adjusted per study, odds ratio converted to relative risk, multivariable, day 14.

risk of oxygen therapy, 39.7% lower, RR 0.60, p = 0.06, treatment 22 of 202 (10.9%), control 33 of 203 (16.3%), NNT 19, adjusted per study, odds ratio converted to relative risk, multivariable, day 14.

time to improvement, 63.6% lower, HR 0.36, p < 0.001, treatment 202, control 203, inverted to make HR<1 favor treatment, Kaplan–Meier.

improvement, 34.2% better, OR 0.66, p = 0.14, treatment 202, control 203, adjusted per study, inverted to make OR<1 favor treatment, multivariable, day 14, RR approximated with OR.

time to discharge, 27.0% lower, HR 0.73, p = 0.004, treatment 202, control 203, inverted to make HR<1 favor treatment, Kaplan–Meier.

discharge, 8.3% lower, OR 0.92, p = 0.82, treatment 202, control 203, adjusted per study, inverted to make OR<1 favor treatment, multivariable, day 14, RR approximated with OR.

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Rocco et al., 13 Apr 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Brazil, peer-reviewed, median age 56.0, 37 authors, study period 20 April, 2020 - 2 October, 2020, trial NCT04561219 (history).

Contact: prmrocco@biof.ufrj.br.

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Abstract: ORIGINAL RESEARCH published: 13 April 2022 doi: 10.3389/fmed.2022.844728 Edited by: Mehdi Mirsaeidi, University of Florida, United States Reviewed by: Jennifer Tom, GRAIL, United States Abdolrazagh Hashemi Shahraki, University of Florida, United States *Correspondence: Patricia R. M. Rocco prmrocco@biof.ufrj.br † These authors have contributed equally to this work ‡ The SARITA Investigators are listed in the Supplementary Information Specialty section: This article was submitted to Pulmonary Medicine, a section of the journal Frontiers in Medicine Received: 28 December 2021 Accepted: 22 March 2022 Published: 13 April 2022 Citation: Rocco PRM, Silva PL, Cruz FF, Tierno PFGMM, Rabello E, Junior JC, Haag F, de Ávila RE, da Silva JDG, Mamede MMS, Buchele KS, Barbosa LCV, Cabral AC, Junqueira AAF, Araújo-Filho JA, da Costa LATJ, Alvarenga PPM, Moura AS, Carajeleascow R, de Oliveira MC, Silva RGF, Soares CRP, Fernandes APSM, Fonseca FG, Camargos VN, Reis JdS, Franchini KG, Luiz RR, Morais S, Sverdloff C, Martins CM, Felix NS, Mattos-Silva P, Nogueira CMB, Caldeira DAF, Pelosi P and Lapa-e-Silva JR (2022) Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Front. Med. 9:844728. doi: 10.3389/fmed.2022.844728 Frontiers in Medicine | www.frontiersin.org Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial Patricia R. M. Rocco 1*† , Pedro L. Silva 1† , Fernanda F. Cruz 1† , Paulo F. G. M. M. Tierno 2 , Eucir Rabello 3 , Jéfiton Cordeiro Junior 4 , Firmino Haag 5 , Renata E. de Ávila 6 , Joana D. G. da Silva 7 , Mariana M. S. Mamede 8 , Konrad S. Buchele 9 , Luiz C. V. Barbosa 10 , Anna C. Cabral 11 , Antônio A. F. Junqueira 12 , João A. Araújo-Filho 13 , Lucianna A. T. J. da Costa 14 , Pedro P. M. Alvarenga 15 , Alexandre S. Moura 16 , Ricardo Carajeleascow 17 , Mirella C. de Oliveira 18 , Roberta G. F. Silva 19 , Cynthia R. P. Soares 20 , Ana Paula S. M. Fernandes 21 , Flavio Guimarães Fonseca 21 , Vidyleison Neves Camargos 21 , Julia de Souza Reis 21 , Kleber G. Franchini 22 , Ronir R. Luiz 1 , Sirlei Morais 23 , Carlos Sverdloff 23 , Camila Marinelli Martins 24 , Nathane S. Felix 1 , Paula Mattos-Silva 1 , Caroline M. B. Nogueira 1 , Dayene A. F. Caldeira 1 , Paolo Pelosi 25,26 and José R. Lapa-e-Silva 1 on behalf of the SARITA-1 Investigators‡ Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil, 2 Hospital Municipal de Barueri Dr. Francisco Moran, Barueri, Brazil, 3 Hospital da Força Aérea do Galeão, Rio de Janeiro, Brazil, 4 Hospital Regional de Sorocaba Dr. Adib D Jatene- Bata Branca, São Paulo, Brazil, 5 Hospital Geral de São Mateus – Dr. Manoel Bifulco, São Mateus, Brazil, 6 Hospital Eduardo Menezes, Belo Horizonte, Brazil, 7 Hospital Regional da Asa Norte, Brasília, Brazil, 8 Hospital das Forças Armadas, Brasília, Brazil, 9 Hospital Naval Marcilio Dias, Rio de Janeiro, Brazil, 10 Hospital das Clínicas Luzia de Pinho Melo, Mogi das Cruzes, Brazil, 11 Hospital Universitário Pedro Ernesto, Rio de Janeiro, Brazil, 12 Hospital Central da Aeronáutica, Rio de Janeiro, Brazil, 13 Hospital Estadual de Doenças Tropicais Dr. Anuar Auad, Anápolis, Brazil, 14 Hospital Geral de Fortaleza, Fortaleza, Brazil, 15 Hospital Mater Dei, Belo Horizonte, Brazil, 16 Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte, Brazil, 17 Complexo..

Late treatment
is less effective

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