Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia : A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
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..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
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| Enthalten in: |
Frontiers in medicine - 9(2022) vom: 01., Seite 844728 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
COVID-19 |
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| Anmerkungen: |
Date Revised 03.05.2022 published: Electronic-eCollection ClinicalTrials.gov: NCT04561219 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.3389/fmed.2022.844728 |
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NLM340211059 |
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| 100 | 1 | |a Rocco, Patricia R M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia |b A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Revised 03.05.2022 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a ClinicalTrials.gov: NCT04561219 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a 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. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a Conclusions: Nitazoxanide, compared with placebo, did not prevent admission to the intensive care unit for patients hospitalized with COVID-19 pneumonia | ||
| 520 | |a Clinical Trial Registration: Brazilian Registry of Clinical Trials (REBEC) RBR88bs9x; ClinicalTrials.gov, NCT04561219 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a D-dimer | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a oxygenation | |
| 650 | 4 | |a pneumonia | |
| 700 | 1 | |a Silva, Pedro L |e verfasserin |4 aut | |
| 700 | 1 | |a Cruz, Fernanda F |e verfasserin |4 aut | |
| 700 | 1 | |a Tierno, Paulo F G M M |e verfasserin |4 aut | |
| 700 | 1 | |a Rabello, Eucir |e verfasserin |4 aut | |
| 700 | 1 | |a Junior, Jéfiton Cordeiro |e verfasserin |4 aut | |
| 700 | 1 | |a Haag, Firmino |e verfasserin |4 aut | |
| 700 | 1 | |a de Ávila, Renata E |e verfasserin |4 aut | |
| 700 | 1 | |a da Silva, Joana D G |e verfasserin |4 aut | |
| 700 | 1 | |a Mamede, Mariana M S |e verfasserin |4 aut | |
| 700 | 1 | |a Buchele, Konrad S |e verfasserin |4 aut | |
| 700 | 1 | |a Barbosa, Luiz C V |e verfasserin |4 aut | |
| 700 | 1 | |a Cabral, Anna C |e verfasserin |4 aut | |
| 700 | 1 | |a Junqueira, Antônio A F |e verfasserin |4 aut | |
| 700 | 1 | |a Araújo-Filho, João A |e verfasserin |4 aut | |
| 700 | 1 | |a da Costa, Lucianna A T J |e verfasserin |4 aut | |
| 700 | 1 | |a Alvarenga, Pedro P M |e verfasserin |4 aut | |
| 700 | 1 | |a Moura, Alexandre S |e verfasserin |4 aut | |
| 700 | 1 | |a Carajeleascow, Ricardo |e verfasserin |4 aut | |
| 700 | 1 | |a de Oliveira, Mirella C |e verfasserin |4 aut | |
| 700 | 1 | |a Silva, Roberta G F |e verfasserin |4 aut | |
| 700 | 1 | |a Soares, Cynthia R P |e verfasserin |4 aut | |
| 700 | 1 | |a Fernandes, Ana Paula S M |e verfasserin |4 aut | |
| 700 | 1 | |a Fonseca, Flavio Guimarães |e verfasserin |4 aut | |
| 700 | 1 | |a Camargos, Vidyleison Neves |e verfasserin |4 aut | |
| 700 | 1 | |a Reis, Julia de Souza |e verfasserin |4 aut | |
| 700 | 1 | |a Franchini, Kleber G |e verfasserin |4 aut | |
| 700 | 1 | |a Luiz, Ronir R |e verfasserin |4 aut | |
| 700 | 1 | |a Morais, Sirlei |e verfasserin |4 aut | |
| 700 | 1 | |a Sverdloff, Carlos |e verfasserin |4 aut | |
| 700 | 1 | |a Martins, Camila Marinelli |e verfasserin |4 aut | |
| 700 | 1 | |a Felix, Nathane S |e verfasserin |4 aut | |
| 700 | 1 | |a Mattos-Silva, Paula |e verfasserin |4 aut | |
| 700 | 1 | |a Nogueira, Caroline M B |e verfasserin |4 aut | |
| 700 | 1 | |a Caldeira, Dayene A F |e verfasserin |4 aut | |
| 700 | 1 | |a Pelosi, Paolo |e verfasserin |4 aut | |
| 700 | 1 | |a Lapa-E-Silva, José R |e verfasserin |4 aut | |
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