TY - JOUR
T1 - Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia
T2 - A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
AU - The SARITA-1 Investigators
AU - Rocco, Patricia R.M.
AU - Silva, Pedro L.
AU - Cruz, Fernanda F.
AU - Tierno, Paulo F.G.M.M.
AU - Rabello, Eucir
AU - Junior, Jéfiton Cordeiro
AU - Haag, Firmino
AU - de Ávila, Renata E.
AU - da Silva, Joana D.G.
AU - Mamede, Mariana M.S.
AU - Buchele, Konrad S.
AU - Barbosa, Luiz C.V.
AU - Cabral, Anna C.
AU - Junqueira, Antônio A.F.
AU - Araújo-Filho, João A.
AU - da Costa, Lucianna A.T.J.
AU - Alvarenga, Pedro P.M.
AU - Moura, Alexandre S.
AU - Carajeleascow, Ricardo
AU - de Oliveira, Mirella C.
AU - Silva, Roberta G.F.
AU - Soares, Cynthia R.P.
AU - Fernandes, Ana Paula S.M.
AU - Fonseca, Flavio Guimarães
AU - Camargos, Vidyleison Neves
AU - Reis, Julia de Souza
AU - Franchini, Kleber G.
AU - Luiz, Ronir R.
AU - Morais, Sirlei
AU - Sverdloff, Carlos
AU - Martins, Camila Marinelli
AU - Felix, Nathane S.
AU - Mattos-Silva, Paula
AU - Nogueira, Caroline M.B.
AU - Caldeira, Dayene A.F.
AU - Pelosi, Paolo
AU - Lapa-e-Silva, José R.
N1 - Publisher Copyright:
Copyright © 2022 Rocco, Silva, Cruz, Tierno, Rabello, Junior, Haag, de Ávila, da Silva, Mamede, Buchele, Barbosa, Cabral, Junqueira, Araújo-Filho, da Costa, Alvarenga, Moura, Carajeleascow, de Oliveira, Silva, Soares, Fernandes, Fonseca, Camargos, Reis, Franchini, Luiz, Morais, Sverdloff, Martins, Felix, Mattos-Silva, Nogueira, Caldeira, Pelosi and Lapa-e-Silva.
PY - 2022/4/13
Y1 - 2022/4/13
N2 - 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. Clinical Trial Registration: Brazilian Registry of Clinical Trials (REBEC) RBR88bs9x; ClinicalTrials.gov, NCT04561219.
AB - 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. Clinical Trial Registration: Brazilian Registry of Clinical Trials (REBEC) RBR88bs9x; ClinicalTrials.gov, NCT04561219.
KW - COVID-19
KW - D-dimer
KW - SARS-CoV-2
KW - oxygenation
KW - pneumonia
UR - http://www.scopus.com/inward/record.url?scp=85133933993&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85133933993&partnerID=8YFLogxK
U2 - 10.3389/fmed.2022.844728
DO - 10.3389/fmed.2022.844728
M3 - Article
C2 - 35492335
AN - SCOPUS:85133933993
SN - 2296-858X
VL - 9
JO - Frontiers in Medicine
JF - Frontiers in Medicine
M1 - 844728
ER -