Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial

Detalhes bibliográficos
Autor(a) principal: Tavares, M
Data de Publicação: 2021
Outros Autores: Farraia, M, Silva, S, Ribeiro, AM, Severo, M, Paciência, I, Ribeiro, R, Hespanhol, V, Guimarães, T, Almeida, J, Magro, F, Sarmento, A, Oliveira, AM, Moreira, A
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: https://hdl.handle.net/10216/149735
Resumo: Background: Montelukast, a safe drug widely use in asthmatic patients, may be an adjuvant in the treatment of Covid-19, either by improving lung injury and inflammation, or by acting as an anti-viral drug. We aim to assess the efficacy and safety of montelukast as add-on treatment in patients with Covid-19. Methods: We propose a randomized, controlled, parallel, open-label trial involving 160 hospitalized adult patients with confirmed Covid-19. Patients will be randomly assigned in a 1:1 ratio to receive either montelukast 10 mg, once a day for 14 days, in addition to standard of care (SoC), or SoC alone. SoC will follow the best practice for treating these patients, according to updated recommendations. The primary outcome is time to recovery. Participants will be assessed using diary cards to capture data on treatment-related improvements in an 8-point ordinal scale. Secondary endpoints will include changes in respiratory and inflammatory parameters, and adverse events. This phase IV clinical trial will take place at the University Hospital of São João, Porto. EudraCT number: 2020-001747-21. Results: This study intends to generate scientific evidence on efficacy and safety of montelukast as add-on treatment in Covid-19. The results will be essential to improve clinical outcomes which remains to be determined. Conclusion: Montelukast has been suggested as a potential drug with 2 main actions on Covid-19. The validation of montelukast as an adjuvant treatment may improve lung injury, inflammation, and symptoms leading to a better prognosis. The use of this drug may fulfil the existing gap on therapeutic options.
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spelling Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trialCovid-19SARS-CoV-2coronavirusmontelukastrandomized controlled trialtreatmentBackground: Montelukast, a safe drug widely use in asthmatic patients, may be an adjuvant in the treatment of Covid-19, either by improving lung injury and inflammation, or by acting as an anti-viral drug. We aim to assess the efficacy and safety of montelukast as add-on treatment in patients with Covid-19. Methods: We propose a randomized, controlled, parallel, open-label trial involving 160 hospitalized adult patients with confirmed Covid-19. Patients will be randomly assigned in a 1:1 ratio to receive either montelukast 10 mg, once a day for 14 days, in addition to standard of care (SoC), or SoC alone. SoC will follow the best practice for treating these patients, according to updated recommendations. The primary outcome is time to recovery. Participants will be assessed using diary cards to capture data on treatment-related improvements in an 8-point ordinal scale. Secondary endpoints will include changes in respiratory and inflammatory parameters, and adverse events. This phase IV clinical trial will take place at the University Hospital of São João, Porto. EudraCT number: 2020-001747-21. Results: This study intends to generate scientific evidence on efficacy and safety of montelukast as add-on treatment in Covid-19. The results will be essential to improve clinical outcomes which remains to be determined. Conclusion: Montelukast has been suggested as a potential drug with 2 main actions on Covid-19. The validation of montelukast as an adjuvant treatment may improve lung injury, inflammation, and symptoms leading to a better prognosis. The use of this drug may fulfil the existing gap on therapeutic options.Wolters Kluwer Health20212021-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10216/149735eng2444-866410.1097/j.pbj.0000000000000134Tavares, MFarraia, MSilva, SRibeiro, AMSevero, MPaciência, IRibeiro, RHespanhol, VGuimarães, TAlmeida, JMagro, FSarmento, AOliveira, AMMoreira, Ainfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-29T12:57:48Zoai:repositorio-aberto.up.pt:10216/149735Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T23:30:31.473309Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial
title Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial
spellingShingle Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial
Tavares, M
Covid-19
SARS-CoV-2
coronavirus
montelukast
randomized controlled trial
treatment
title_short Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial
title_full Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial
title_fullStr Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial
title_full_unstemmed Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial
title_sort Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial
author Tavares, M
author_facet Tavares, M
Farraia, M
Silva, S
Ribeiro, AM
Severo, M
Paciência, I
Ribeiro, R
Hespanhol, V
Guimarães, T
Almeida, J
Magro, F
Sarmento, A
Oliveira, AM
Moreira, A
author_role author
author2 Farraia, M
Silva, S
Ribeiro, AM
Severo, M
Paciência, I
Ribeiro, R
Hespanhol, V
Guimarães, T
Almeida, J
Magro, F
Sarmento, A
Oliveira, AM
Moreira, A
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Tavares, M
Farraia, M
Silva, S
Ribeiro, AM
Severo, M
Paciência, I
Ribeiro, R
Hespanhol, V
Guimarães, T
Almeida, J
Magro, F
Sarmento, A
Oliveira, AM
Moreira, A
dc.subject.por.fl_str_mv Covid-19
SARS-CoV-2
coronavirus
montelukast
randomized controlled trial
treatment
topic Covid-19
SARS-CoV-2
coronavirus
montelukast
randomized controlled trial
treatment
description Background: Montelukast, a safe drug widely use in asthmatic patients, may be an adjuvant in the treatment of Covid-19, either by improving lung injury and inflammation, or by acting as an anti-viral drug. We aim to assess the efficacy and safety of montelukast as add-on treatment in patients with Covid-19. Methods: We propose a randomized, controlled, parallel, open-label trial involving 160 hospitalized adult patients with confirmed Covid-19. Patients will be randomly assigned in a 1:1 ratio to receive either montelukast 10 mg, once a day for 14 days, in addition to standard of care (SoC), or SoC alone. SoC will follow the best practice for treating these patients, according to updated recommendations. The primary outcome is time to recovery. Participants will be assessed using diary cards to capture data on treatment-related improvements in an 8-point ordinal scale. Secondary endpoints will include changes in respiratory and inflammatory parameters, and adverse events. This phase IV clinical trial will take place at the University Hospital of São João, Porto. EudraCT number: 2020-001747-21. Results: This study intends to generate scientific evidence on efficacy and safety of montelukast as add-on treatment in Covid-19. The results will be essential to improve clinical outcomes which remains to be determined. Conclusion: Montelukast has been suggested as a potential drug with 2 main actions on Covid-19. The validation of montelukast as an adjuvant treatment may improve lung injury, inflammation, and symptoms leading to a better prognosis. The use of this drug may fulfil the existing gap on therapeutic options.
publishDate 2021
dc.date.none.fl_str_mv 2021
2021-01-01T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://hdl.handle.net/10216/149735
url https://hdl.handle.net/10216/149735
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 2444-8664
10.1097/j.pbj.0000000000000134
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Wolters Kluwer Health
publisher.none.fl_str_mv Wolters Kluwer Health
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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