Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial
Q1
- Autores:
-
Gaitán-Duarte, H.G
Álvarez-Moreno, C.
Rincon, Carlos Javier
Yomayusa-González, N.
Cortés, J.A.
Villar, J.C.
Bravo-Ojeda, J.S
Garcia-Pena, A.A.
Adarme-Jaimes, W.
Rodriguez, Viviana
Villate-Soto, S.L.
Buitrago, G.
Chacón-Sarmiento, J.
Macias-Quintero, M.
Vaca, C.P.
Gomez-Restrepo, Carlos
Rodríguez, Nelcy
- Tipo de recurso:
- Article of investigation
- Fecha de publicación:
- 2021
- Institución:
- Pontificia Universidad Javeriana
- Repositorio:
- Repositorio Universidad Javeriana
- Idioma:
- eng
- OAI Identifier:
- oai:repository.javeriana.edu.co:10554/59031
- Acceso en línea:
- https://www.sciencedirect.com/science/article/pii/S258953702100523X?via%3Dihub#!
http://hdl.handle.net/10554/59031
https://doi.org/10.1016/j.eclinm.2021.101242
- Palabra clave:
- COVID-19
Ensayo
Hospitalized patients
SARS-CoV-2
COVID-19
Open-label randomized trial
Hospitalized patients
SARS-CoV-2
- Rights
- License
- Atribución-NoComercial 4.0 Internacional
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| dc.title.spa.fl_str_mv |
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial |
| title |
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial |
| spellingShingle |
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial COVID-19 Ensayo Hospitalized patients SARS-CoV-2 COVID-19 Open-label randomized trial Hospitalized patients SARS-CoV-2 |
| title_short |
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial |
| title_full |
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial |
| title_fullStr |
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial |
| title_full_unstemmed |
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial |
| title_sort |
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial |
| dc.creator.fl_str_mv |
Gaitán-Duarte, H.G Álvarez-Moreno, C. Rincon, Carlos Javier Yomayusa-González, N. Cortés, J.A. Villar, J.C. Bravo-Ojeda, J.S Garcia-Pena, A.A. Adarme-Jaimes, W. Rodriguez, Viviana Villate-Soto, S.L. Buitrago, G. Chacón-Sarmiento, J. Macias-Quintero, M. Vaca, C.P. Gomez-Restrepo, Carlos Rodríguez, Nelcy |
| dc.contributor.author.none.fl_str_mv |
Gaitán-Duarte, H.G Álvarez-Moreno, C. Rincon, Carlos Javier Yomayusa-González, N. Cortés, J.A. Villar, J.C. Bravo-Ojeda, J.S Garcia-Pena, A.A. Adarme-Jaimes, W. Rodriguez, Viviana Villate-Soto, S.L. Buitrago, G. Chacón-Sarmiento, J. Macias-Quintero, M. Vaca, C.P. Gomez-Restrepo, Carlos Rodríguez, Nelcy |
| dc.contributor.corporatename.spa.fl_str_mv |
Pontificia Universidad Javeriana. Facultad de Medicina. Departamento de Epidemiología Clínica y Bioestadística |
| dc.contributor.corporatename.none.fl_str_mv |
Pontificia Universidad Javeriana. Facultad de Medicina. Departamento de Medicina Interna. Cardiología |
| dc.contributor.javerianateacher.none.fl_str_mv |
Garcia-Pena, A.A. Rincon, Carlos Javier Rodriguez, Viviana Gomez-Restrepo, Carlos Rodríguez, Nelcy |
| dc.subject.spa.fl_str_mv |
COVID-19 Ensayo Hospitalized patients SARS-CoV-2 |
| topic |
COVID-19 Ensayo Hospitalized patients SARS-CoV-2 COVID-19 Open-label randomized trial Hospitalized patients SARS-CoV-2 |
| dc.subject.keyword.spa.fl_str_mv |
COVID-19 Open-label randomized trial Hospitalized patients SARS-CoV-2 |
| description |
Q1 |
| publishDate |
2021 |
| dc.date.created.none.fl_str_mv |
2021-12-20 |
| dc.date.accessioned.none.fl_str_mv |
2022-02-09T14:46:29Z |
| dc.date.available.none.fl_str_mv |
2022-02-09T14:46:29Z |
| dc.type.local.spa.fl_str_mv |
Artículo de revista |
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http://purl.org/coar/resource_type/c_2df8fbb1 |
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http://purl.org/coar/resource_type/c_2df8fbb1 |
| dc.identifier.spa.fl_str_mv |
https://www.sciencedirect.com/science/article/pii/S258953702100523X?via%3Dihub#! |
| dc.identifier.issn.spa.fl_str_mv |
2589-5370 |
| dc.identifier.uri.none.fl_str_mv |
http://hdl.handle.net/10554/59031 |
| dc.identifier.doi.spa.fl_str_mv |
https://doi.org/10.1016/j.eclinm.2021.101242 |
| dc.identifier.instname.spa.fl_str_mv |
instname:Pontificia Universidad Javeriana |
| dc.identifier.reponame.spa.fl_str_mv |
reponame:Repositorio Institucional - Pontificia Universidad Javeriana |
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repourl:https://repository.javeriana.edu.co |
| url |
https://www.sciencedirect.com/science/article/pii/S258953702100523X?via%3Dihub#! http://hdl.handle.net/10554/59031 https://doi.org/10.1016/j.eclinm.2021.101242 |
| identifier_str_mv |
2589-5370 instname:Pontificia Universidad Javeriana reponame:Repositorio Institucional - Pontificia Universidad Javeriana repourl:https://repository.javeriana.edu.co |
| dc.language.iso.spa.fl_str_mv |
eng |
| language |
eng |
| dc.relation.citationstartpage.spa.fl_str_mv |
1 |
| dc.relation.citationendpage.spa.fl_str_mv |
12 |
| dc.relation.ispartofjournal.spa.fl_str_mv |
EClinicalMedicine |
| dc.relation.citationvolume.spa.fl_str_mv |
43 |
| dc.rights.licence.*.fl_str_mv |
Atribución-NoComercial 4.0 Internacional |
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http://creativecommons.org/licenses/by-nc/4.0/ |
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http://purl.org/coar/access_right/c_abf2 |
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Atribución-NoComercial 4.0 Internacional http://creativecommons.org/licenses/by-nc/4.0/ http://purl.org/coar/access_right/c_abf2 |
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PDF |
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application/pdf |
| dc.coverage.spatial.spa.fl_str_mv |
Colombia |
| dc.coverage.city.spa.fl_str_mv |
Bogotá (Colombia) |
| institution |
Pontificia Universidad Javeriana |
| bitstream.url.fl_str_mv |
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Atribución-NoComercial 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc/4.0/http://purl.org/coar/access_right/c_abf2Gaitán-Duarte, H.GÁlvarez-Moreno, C.Rincon, Carlos JavierYomayusa-González, N.Cortés, J.A.Villar, J.C.Bravo-Ojeda, J.SGarcia-Pena, A.A.Adarme-Jaimes, W.Rodriguez, VivianaVillate-Soto, S.L.Buitrago, G.Chacón-Sarmiento, J.Macias-Quintero, M.Vaca, C.P.Gomez-Restrepo, CarlosRodríguez, NelcyPontificia Universidad Javeriana. Facultad de Medicina. Departamento de Epidemiología Clínica y BioestadísticaPontificia Universidad Javeriana. Facultad de Medicina. Departamento de Medicina Interna. CardiologíaGarcia-Pena, A.A.Rincon, Carlos JavierRodriguez, VivianaGomez-Restrepo, CarlosRodríguez, NelcyColombiaBogotá (Colombia)2022-02-09T14:46:29Z2022-02-09T14:46:29Z2021-12-20https://www.sciencedirect.com/science/article/pii/S258953702100523X?via%3Dihub#!2589-5370http://hdl.handle.net/10554/59031https://doi.org/10.1016/j.eclinm.2021.101242instname:Pontificia Universidad Javerianareponame:Repositorio Institucional - Pontificia Universidad Javerianarepourl:https://repository.javeriana.edu.coPDFapplication/pdfengCOVID-19EnsayoHospitalized patientsSARS-CoV-2COVID-19Open-label randomized trialHospitalized patientsSARS-CoV-2Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trialArtículo de revistahttp://purl.org/coar/resource_type/c_2df8fbb1Q1Q1Pacientes con COVID-19Background: The use of rosuvastatin plus colchicine and emtricitabine/tenofovir in hospitalized patients with SARS- CoV-2 disease (COVID-19) has not been assessed. The objective of this study was to assess the effectiveness and safety of rosuvastatin plus colchicine, emtricitabine/tenofovir, and their combined use in these patients. Methods: This was a randomized, controlled, open-label, multicentre, parallel, pragmatic study conducted in six referral hospitals in Bogotá, Colombia. The study enrolled hospitalized patients over 18 years of age with a confirmed diagnosis of COVID-19 complicated with pneumonia, not on chronic treatment with the study medications, and with no contraindications for their use. Patients were assigned 1:1:1:1. 1) emtricitabine with tenofovir disoproxil fumarate (FTC/TDF, 200/300 mg given orally for 10 days); 2) colchicine plus rosuvastatin (COLCH+ROSU, 0.5 mg and 40 mg given orally for 14 days); 3) emtricitabine with tenofovir disoproxil plus colchicine and rosuvastatin at the same doses and for the same period of time (FTC/TDF+COLCH+ROSU); or 4) the Colombian consensus standard of care, including a corticosteroid (SOC). The primary endpoint was 28-day all-cause mortality. A modified intention-to-treat analysis was used together with a usefulness analysis to determine which could be the best treatment. The trial was registered at ClinicalTrials.gov: NCT04359095. Findings: Out of 994 candidates considered between August 2020 and March 2021, 649 (65.3%) patients agreed to participate and were enrolled in this study; among them, 633 (97.5%) were included in the analysis. The mean age was 55.4 years (SD § 12.8 years), and 428 (68%) were men; 28-day mortality was significantly lower in the FTC/ TDF+COLCH+ROSUV group than in the SOC group, 10.7% (17/159) vs. 17.4% (28/161) (hazard ratio [HR] 0.53; 95% CI 0.29 to 0.96). Mortality in the FTC/TDF group was 13.8% (22/160, HR 0.68, 95% CI 0.39 to 1.20) and 14.4% in the COLCH+ROSU group (22/153) (HR 0.78, 95% CI 0.44 to 1.36). A lower need for invasive mechanical ventilation was observed in the FTC/TDF+COLCH+ROSUV group than in the SOC group (risk difference [RD] - 0.08, 95% CI 0.11 to 0.04). Three patients presented severe adverse events, one severe diarrhoea in the COLCH +ROSU and one in the FTC/TDF+COLCH+ROSU group and one general exanthema in the FTC/TDF group. Interpretation: The combined use of FTC/TDF+COLCH+ROSU reduces the risk of 28-day mortality and the need for invasive mechanical ventilation in hospitalized patients with pulmonary compromise from COVID-19. More randomized controlled trials are needed to compare the effectiveness and cost of treatment with this combination versus other drugs that have been shown to reduce mortality from SARS-CoV-2 infection and its usefulness in patients with chronic statin use.https://orcid.org/0000-0002-3606-2102https://orcid.org/0000-0002-0477-1908https://orcid.org/0000-0001-8487-0676https://orcid.org/0000-0002-9013-5384https://orcid.org/0000-0003-4320-695XRevista Internacional - IndexadaA1112EClinicalMedicine43LICENSElicense.txtlicense.txttext/plain; charset=utf-82603http://repository.javeriana.edu.co/bitstream/10554/59031/2/license.txt2070d280cc89439d983d9eee1b17df53MD52open accessORIGINALEffectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trialEffectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trialArtículoapplication/pdf991994http://repository.javeriana.edu.co/bitstream/10554/59031/1/Effectiveness%20of%20rosuvastatin%20plus%20colchicine%2c%20emtricitabine/tenofovir%20and%20combinations%20thereof%20in%20hospitalized%20patients%20with%20COVID-19%3a%20a%20pragmatic%2c%20open-label%20randomized%20trial27da64adbc9704a648e911e937624c71MD51open accessTHUMBNAILEffectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial.jpgEffectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial.jpgIM Thumbnailimage/jpeg9573http://repository.javeriana.edu.co/bitstream/10554/59031/3/Effectiveness%20of%20rosuvastatin%20plus%20colchicine%2c%20emtricitabine/tenofovir%20and%20combinations%20thereof%20in%20hospitalized%20patients%20with%20COVID-19%3a%20a%20pragmatic%2c%20open-label%20randomized%20trial.jpga01b0f45a2a5cab275837bc971e0ee60MD53open access10554/59031oai:repository.javeriana.edu.co:10554/590312023-05-18 15:22:11.638Repositorio Institucional - Pontificia Universidad Javerianarepositorio@javeriana.edu.coTElDRU5DSUEgWSBBVVRPUklaQUNJw5NOIERFIExPUyBBVVRPUkVTIFBBUkEgUFVCTElDQVIgWSBQRVJNSVRJUiBMQSBDT05TVUxUQSBZIFVTTy4KClBhcnRlIDEuIFTDqXJtaW5vcyBkZSBsYSBsaWNlbmNpYSBnZW5lcmFsIHBhcmEgcHVibGljYWNpw7NuIGRlIG9icmFzIGVuIGVsIHJlcG9zaXRvcmlvIGluc3RpdHVjaW9uYWwKQ29tbyB0aXR1bGFyIChlcykgZGVsIGRlcmVjaG8gZGUgYXV0b3IsIGNvbmZpZXJvIChlcmltb3MpIGEgbGEgUG9udGlmaWNpYSBVbml2ZXJzaWRhZCBKYXZlcmlhbmEgdW5hIGxpY2VuY2lhIG5vIGV4Y2x1c2l2YSwgbGltaXRhZGEgeSBncmF0dWl0YSBzb2JyZSBsYSBvYnJhIHF1ZSBzZSBpbnRlZ3JhcsOhIGVuIGVsIFJlcG9zaXRvcmlvIEluc3RpdHVjaW9uYWwsIHF1ZSBzZSBhanVzdGEgYSBsYXMgc2lndWllbnRlcyBjYXJhY3RlcsOtc3RpY2FzOgphKSAgICAgIEVzdGFyw6EgdmlnZW50ZSBhIHBhcnRpciBkZSBsYSBmZWNoYSBkZSBpbmNsdXNpw7NuIGVuIGVsIHJlcG9zaXRvcmlvLCBwb3IgdW4gcGxhem8gZGUgNSBhw7FvcywgcXVlIHNlcsOhbiBwcm9ycm9nYWJsZXMgaW5kZWZpbmlkYW1lbnRlIHBvciBlbCB0aWVtcG8gcXVlIGR1cmUgZWwgZGVyZWNobyBwYXRyaW1vbmlhbCBkZWwgYXV0b3IuIEVsIGF1dG9yIHBvZHLDoSBkYXIgcG9yIHRlcm1pbmFkYSBsYSBsaWNlbmNpYSBzb2xpY2l0w6FuZG9sbyBhIGxhIFVuaXZlcnNpZGFkIHBvciBlc2NyaXRvLgpiKSAgICAgIEF1dG9yaXphIGEgbGEgUG9udGlmaWNpYSBVbml2ZXJzaWRhZCBKYXZlcmlhbmEgYSBwdWJsaWNhciBsYSBvYnJhIGVuIGRpZ2l0YWwsIGNvbm9jaWVuZG8gcXVlLCBkYWRvIHF1ZSBzZSBwdWJsaWNhIGVuIEludGVybmV0LCBwb3IgZXN0ZSBoZWNobyBjaXJjdWxhIGNvbiB1biBhbGNhbmNlIG11bmRpYWwuCmMpICAgICAgTG9zIGF1dG9yZXMgYWNlcHRhbiBxdWUgbGEgYXV0b3JpemFjacOzbiBzZSBoYWNlIGEgdMOtdHVsbyBncmF0dWl0bywgcG9yIGxvIHRhbnRvIHJlbnVuY2lhbiBhIHJlY2liaXIgYmVuZWZpY2lvIGFsZ3VubyBwb3IgbGEgcHVibGljYWNpw7NuLCBkaXN0cmlidWNpw7NuLCBjb211bmljYWNpw7NuIHDDumJsaWNhIHkgY3VhbHF1aWVyIG90cm8gdXNvIHF1ZSBzZSBoYWdhIGVuIGxvcyB0w6lybWlub3MgZGUgbGEgcHJlc2VudGUgbGljZW5jaWEgeSBkZSBsYSBsaWNlbmNpYSBkZSB1c28gY29uIHF1ZSBzZSBwdWJsaWNhLgpkKSAgICAgIExvcyBhdXRvcmVzIG1hbmlmaWVzdGFuIHF1ZSBzZSB0cmF0YSBkZSB1bmEgb2JyYSBvcmlnaW5hbCBzb2JyZSBsYSBxdWUgdGllbmVuIGxvcyBkZXJlY2hvcyBxdWUgYXV0b3JpemFuIHkgcXVlIHNvbiBlbGxvcyBxdWllbmVzIGFzdW1lbiB0b3RhbCByZXNwb25zYWJpbGlkYWQgcG9yIGVsIGNvbnRlbmlkbyBkZSBzdSBvYnJhIGFudGUgbGEgUG9udGlmaWNpYSBVbml2ZXJzaWRhZCBKYXZlcmlhbmEgeSBhbnRlIHRlcmNlcm9zLiBFbiB0b2RvIGNhc28gbGEgUG9udGlmaWNpYSBVbml2ZXJzaWRhZCBKYXZlcmlhbmEgc2UgY29tcHJvbWV0ZSBhIGluZGljYXIgc2llbXByZSBsYSBhdXRvcsOtYSBpbmNsdXllbmRvIGVsIG5vbWJyZSBkZWwgYXV0b3IgeSBsYSBmZWNoYSBkZSBwdWJsaWNhY2nDs24uCmUpICAgICAgQXV0b3Jpem8gKGFtb3MpIGEgbGEgVW5pdmVyc2lkYWQgcGFyYSBpbmNsdWlyIGxhIG9icmEgZW4gbG9zIMOtbmRpY2VzIHkgYnVzY2Fkb3JlcyBxdWUgZXN0aW1lbiBuZWNlc2FyaW9zIHBhcmEgcHJvbW92ZXIgc3UgZGlmdXNpw7NuLgpmKSAgICAgIEFjZXB0byAoYW1vcykgcXVlIGxhIFBvbnRpZmljaWEgVW5pdmVyc2lkYWQgSmF2ZXJpYW5hIHB1ZWRhIGNvbnZlcnRpciBlbCBkb2N1bWVudG8gYSBjdWFscXVpZXIgbWVkaW8gbyBmb3JtYXRvIHBhcmEgcHJvcMOzc2l0b3MgZGUgcHJlc2VydmFjacOzbiBkaWdpdGFsLgpnKSAgICAgIEF1dG9yaXpvIChhbW9zKSBxdWUgbGEgb2JyYSBzZWEgcHVlc3RhIGEgZGlzcG9zaWNpw7NuIGRlbCBww7pibGljbyBlbiBsb3MgdMOpcm1pbm9zIGF1dG9yaXphZG9zIGVuIGxvcyBsaXRlcmFsZXMgYW50ZXJpb3JlcyBiYWpvIGxvcyBsw61taXRlcyBkZWZpbmlkb3MgcG9yIGxhIHVuaXZlcnNpZGFkIGVuIGxhcyDigJxDb25kaWNpb25lcyBkZSB1c28gZGUgZXN0cmljdG8gY3VtcGxpbWllbnRv4oCdIGRlIGxvcyByZWN1cnNvcyBwdWJsaWNhZG9zIGVuIFJlcG9zaXRvcmlvIEluc3RpdHVjaW9uYWwgUFVKICwgY3V5byB0ZXh0byBjb21wbGV0byBzZSBwdWVkZSBjb25zdWx0YXIgZW4gaHR0cDovL3JlcG9zaXRvcnkuamF2ZXJpYW5hLmVkdS5jby8KClNJIEVMIERPQ1VNRU5UTyBTRSBCQVNBIEVOIFVOIFRSQUJBSk8gUVVFIEhBIFNJRE8gUEFUUk9DSU5BRE8gTyBBUE9ZQURPIFBPUiBVTkEgQUdFTkNJQSBPIFVOQSBPUkdBTklaQUNJw5NOLCBDT04gRVhDRVBDScOTTiBERSBMQSBQT05USUZJQ0lBIFVOSVZFUlNJREFEIEpBVkVSSUFOQSwgRUwgKExPUykgQVVUT1IoRVMpIEdBUkFOVElaQShNT1MpIFFVRSBTRSBIQSBDVU1QTElETyBDT04gTE9TIERFUkVDSE9TIFkgT0JMSUdBQ0lPTkVTIFJFUVVFUklET1MgUE9SIEVMIFJFU1BFQ1RJVk8gQ09OVFJBVE8gTyBBQ1VFUkRPLgo= |