The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges
Digital
- Autores:
-
Eikelboom, John
Rangarajan, Sumathy
Jolly, Sanjit S.
Belley-Cote, Emilie P.
Whitlock, Richard
Beresh, Heather
Lewis, Gayle
Xu, Lizhen
Chan, Noel
Bangdiwala, Shrikant
Diaz, Rafael
Orlandini, Andres
Hassany, Mohamed
Tarhuni, Wadea M.
Yusufali, A.M.
Sharma, Sanjib Kumar
Kontsevaya, Anna
Lopez-Jaramillo, Patricio
Avezum, Alvaro
Dans, Antonio L.
Wasserman, Sean
Felix, Camilo
Kazmi, Khawar
Pais, Prem
Xavier, Denis
Lopes, Renato D.
Berwanger, Otavio
Nkeshimana, Menelas
Harper, William
Loeb, Mark
Choudhri, Shurjeel
Farkouh, Michael E.
Bosch, Jackie
Anand, Sonia S.
Yusuf, Salim
- Tipo de recurso:
- Article of journal
- Fecha de publicación:
- 2022
- Institución:
- Universidad de Santander
- Repositorio:
- Repositorio Universidad de Santander
- Idioma:
- eng
- OAI Identifier:
- oai:repositorio.udes.edu.co:001/7446
- Acceso en línea:
- https://doi.org/10.1016/j.cjco.2022.02.010
https://repositorio.udes.edu.co/handle/001/7446
- Palabra clave:
- Rights
- openAccess
- License
- © 2022 The Authors. Published by Elsevier Inc. on behalf of the Canadian Cardiovascular Society.
| id |
RUDES2_7b30dde2761cf1e578cb7c4e5c4915d3 |
|---|---|
| oai_identifier_str |
oai:repositorio.udes.edu.co:001/7446 |
| network_acronym_str |
RUDES2 |
| network_name_str |
Repositorio Universidad de Santander |
| repository_id_str |
|
| dc.title.spa.fl_str_mv |
The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges |
| title |
The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges |
| spellingShingle |
The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges |
| title_short |
The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges |
| title_full |
The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges |
| title_fullStr |
The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges |
| title_full_unstemmed |
The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges |
| title_sort |
The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges |
| dc.creator.fl_str_mv |
Eikelboom, John Rangarajan, Sumathy Jolly, Sanjit S. Belley-Cote, Emilie P. Whitlock, Richard Beresh, Heather Lewis, Gayle Xu, Lizhen Chan, Noel Bangdiwala, Shrikant Diaz, Rafael Orlandini, Andres Hassany, Mohamed Tarhuni, Wadea M. Yusufali, A.M. Sharma, Sanjib Kumar Kontsevaya, Anna Lopez-Jaramillo, Patricio Avezum, Alvaro Dans, Antonio L. Wasserman, Sean Felix, Camilo Kazmi, Khawar Pais, Prem Xavier, Denis Lopes, Renato D. Berwanger, Otavio Nkeshimana, Menelas Harper, William Loeb, Mark Choudhri, Shurjeel Farkouh, Michael E. Bosch, Jackie Anand, Sonia S. Yusuf, Salim |
| dc.contributor.author.none.fl_str_mv |
Eikelboom, John Rangarajan, Sumathy Jolly, Sanjit S. Belley-Cote, Emilie P. Whitlock, Richard Beresh, Heather Lewis, Gayle Xu, Lizhen Chan, Noel Bangdiwala, Shrikant Diaz, Rafael Orlandini, Andres Hassany, Mohamed Tarhuni, Wadea M. Yusufali, A.M. Sharma, Sanjib Kumar Kontsevaya, Anna Lopez-Jaramillo, Patricio Avezum, Alvaro Dans, Antonio L. Wasserman, Sean Felix, Camilo Kazmi, Khawar Pais, Prem Xavier, Denis Lopes, Renato D. Berwanger, Otavio Nkeshimana, Menelas Harper, William Loeb, Mark Choudhri, Shurjeel Farkouh, Michael E. Bosch, Jackie Anand, Sonia S. Yusuf, Salim |
| dc.contributor.researchgroup.spa.fl_str_mv |
Masira |
| description |
Digital |
| publishDate |
2022 |
| dc.date.accessioned.none.fl_str_mv |
2022-08-19T19:21:27Z |
| dc.date.available.none.fl_str_mv |
2022-08-19T19:21:27Z |
| dc.date.issued.none.fl_str_mv |
2022-06-05 |
| dc.type.spa.fl_str_mv |
Artículo de revista |
| dc.type.coar.fl_str_mv |
http://purl.org/coar/resource_type/c_2df8fbb1 |
| dc.type.coarversion.fl_str_mv |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.coar.spa.fl_str_mv |
http://purl.org/coar/resource_type/c_6501 |
| dc.type.content.spa.fl_str_mv |
Text |
| dc.type.driver.spa.fl_str_mv |
info:eu-repo/semantics/article |
| dc.type.redcol.spa.fl_str_mv |
http://purl.org/redcol/resource_type/ART |
| dc.type.version.spa.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
| format |
http://purl.org/coar/resource_type/c_6501 |
| status_str |
publishedVersion |
| dc.identifier.doi.none.fl_str_mv |
https://doi.org/10.1016/j.cjco.2022.02.010 |
| dc.identifier.eissn.spa.fl_str_mv |
2589-790X |
| dc.identifier.issn.spa.fl_str_mv |
2589-790X |
| dc.identifier.uri.none.fl_str_mv |
https://repositorio.udes.edu.co/handle/001/7446 |
| url |
https://doi.org/10.1016/j.cjco.2022.02.010 https://repositorio.udes.edu.co/handle/001/7446 |
| identifier_str_mv |
2589-790X |
| dc.language.iso.spa.fl_str_mv |
eng |
| language |
eng |
| dc.relation.citationendpage.spa.fl_str_mv |
576 |
| dc.relation.citationissue.spa.fl_str_mv |
6 |
| dc.relation.citationstartpage.spa.fl_str_mv |
568 |
| dc.relation.citationvolume.spa.fl_str_mv |
4 |
| dc.relation.cites.none.fl_str_mv |
John Eikelboom, Sumathy Rangarajan, Sanjit S. Jolly, Emilie P. Belley-Cote, Richard Whitlock, Heather Beresh, Gayle Lewis, Lizhen Xu, Noel Chan, Shrikant Bangdiwala, Rafael Diaz, Andres Orlandini, Mohamed Hassany, Wadea M. Tarhuni, A.M. Yusufali, Sanjib Kumar Sharma, Anna Kontsevaya, Patricio Lopez-Jaramillo, Alvaro Avezum, Antonio L. Dans, Sean Wasserman, Camilo Felix, Khawar Kazmi, Prem Pais, Denis Xavier, Renato D. Lopes, Otavio Berwanger, Menelas Nkeshimana, William Harper, Mark Loeb, Shurjeel Choudhri, Michael E. Farkouh, Jackie Bosch, Sonia S. Anand, Salim Yusuf, The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges, CJC Open, Volume 4, Issue 6, 2022, Pages 568-576, ISSN 2589-790X, https://doi.org/10.1016/j.cjco.2022.02.010. (https://www.sciencedirect.com/science/article/pii/S2589790X22000488) |
| dc.relation.indexed.spa.fl_str_mv |
Scopus |
| dc.relation.ispartofjournal.spa.fl_str_mv |
CJC Open |
| dc.rights.spa.fl_str_mv |
© 2022 The Authors. Published by Elsevier Inc. on behalf of the Canadian Cardiovascular Society. |
| dc.rights.coar.fl_str_mv |
http://purl.org/coar/access_right/c_abf2 |
| dc.rights.accessrights.spa.fl_str_mv |
info:eu-repo/semantics/openAccess |
| dc.rights.creativecommons.spa.fl_str_mv |
Atribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0) |
| dc.rights.uri.spa.fl_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0/ |
| rights_invalid_str_mv |
© 2022 The Authors. Published by Elsevier Inc. on behalf of the Canadian Cardiovascular Society. Atribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0) https://creativecommons.org/licenses/by-nc-nd/4.0/ http://purl.org/coar/access_right/c_abf2 |
| eu_rights_str_mv |
openAccess |
| dc.format.extent.spa.fl_str_mv |
9 p |
| dc.format.mimetype.spa.fl_str_mv |
application/pdf |
| dc.publisher.place.spa.fl_str_mv |
USA |
| dc.source.spa.fl_str_mv |
https://www.sciencedirect.com/science/article/pii/S2589790X22000488?via%3Dihub#! |
| institution |
Universidad de Santander |
| bitstream.url.fl_str_mv |
https://repositorio.udes.edu.co/bitstreams/40abae68-9eaf-452c-bdcd-b02a57eeb81f/download https://repositorio.udes.edu.co/bitstreams/ff0d67e3-a56b-4361-82d2-de1d943c8f31/download https://repositorio.udes.edu.co/bitstreams/325930dc-8a54-426b-b2dd-961f578d2c7c/download https://repositorio.udes.edu.co/bitstreams/7794c1f8-7bb5-4ab9-945c-bc981eeb8444/download |
| bitstream.checksum.fl_str_mv |
5f6b408dc3015f60f4a2f76e41e8153a 38d94cf55aa1bf2dac1a736ac45c881c 5dbe86c1111d64f45ba435df98fdc825 8dc400efbb3752a52be209976a34469b |
| bitstream.checksumAlgorithm.fl_str_mv |
MD5 MD5 MD5 MD5 |
| repository.name.fl_str_mv |
Repositorio Universidad de Santander |
| repository.mail.fl_str_mv |
soporte@metabiblioteca.com |
| _version_ |
1818101371809824768 |
| spelling |
Eikelboom, Johnc137b240-0c34-4382-97b6-d10a171727b5-1Rangarajan, Sumathy5466c363-e515-4bd2-8537-eb839320f385-1Jolly, Sanjit S.96c04383-b5f0-467c-b752-84487863d81e-1Belley-Cote, Emilie P.3ad9ec11-e491-4d85-b39a-feda22cc145d-1Whitlock, Richard3a10a790-c16b-4a4f-baff-775f57f99a9d-1Beresh, Heather0c3971d8-c4f1-4268-9e46-b76217f49bcf-1Lewis, Gayleb6e3bc5f-197d-4ff1-8943-3134bbd6cbe4-1Xu, Lizhen2811a8be-1770-4d90-b833-1e87d84da140-1Chan, Noelc199481b-a8fe-4dbf-905d-d4158b0bbf84-1Bangdiwala, Shrikante719a52d-08ef-4d4a-b40e-b8436e546307-1Diaz, Rafaelf2be4a74-501a-4e63-8bbd-965cbcf8c57b-1Orlandini, Andrescbafea09-3a82-4064-a22f-d34a0e7583d4-1Hassany, Mohamed52aa83b9-acd3-4b95-a902-94e27d787f3a-1Tarhuni, Wadea M.f0ce9dde-a5f1-4600-bc0b-33f701df22a4-1Yusufali, A.M.0d61b24d-19d7-495d-874e-b0f9394d6e35-1Sharma, Sanjib Kumar8ef84624-ad76-4848-bc73-faae8e886ca2-1Kontsevaya, Anna0730c19a-0095-436b-b889-e18dd7089328-1Lopez-Jaramillo, Patricio9a71267b-dcb0-4d31-b37d-2d30be58d4d2-1Avezum, Alvaro8b920360-abb2-4ec8-b5ee-4e3f4e0b11eb-1Dans, Antonio L.d12865ad-4f3c-47bb-85b5-3f7e16c5cc30-1Wasserman, Seanaeb82d48-02f6-466a-b10a-8d43aa48067f-1Felix, Camilo8f963374-f605-4ca6-8884-7cdaa10d0c3e-1Kazmi, Khawar69af1dac-e1e0-45dd-91e9-6add426eb64e-1Pais, Prem5abdbf77-3c3f-4396-8634-83723aa215b9-1Xavier, Denis88c9cf48-fa3b-45c6-be03-2cc79e59289d-1Lopes, Renato D.0126ea81-3276-4d15-8a42-45344ed27512-1Berwanger, Otavio924bc8b6-8ce9-4633-a2f7-d2bb72b1a988-1Nkeshimana, Menelasf67571f8-1d49-43d2-9dd7-3be51d100991-1Harper, William6147a518-e762-4fab-b9e0-9eb1e4b82498-1Loeb, Mark66be6454-ce21-4cc7-b429-5e6b7191bbfd-1Choudhri, Shurjeel8e12815e-a3be-4a4a-9702-86493f9d7d5c-1Farkouh, Michael E.9ce787ba-feed-48b0-a636-eb33949f2c24-1Bosch, Jackie503f2202-0dda-463c-acc9-f5888e895278-1Anand, Sonia S.76cdf575-775c-4053-960b-9820a2f9db2d-1Yusuf, Salim06a836b5-f5e3-41d9-a516-9cc46e5d7948-1Masira2022-08-19T19:21:27Z2022-08-19T19:21:27Z2022-06-05DigitalBackground: Effective treatments for COVID-19 are urgently needed, but conducting randomized trials during the pandemic has been challenging.Methods: The Anti-Coronavirus Therapy (ACT) trials are parallel factorial international trials that aimed to enroll 3500 outpatients and 2500 inpatients with symptomatic COVID-19. The outpatient trial is evaluating colchicine vs usual care, and aspirin vs usual care. The primary outcome for the colchicine randomization is hospitalization or death, and for the aspirin randomization, it is major thrombosis, hospitalization, or death. The inpatient trial is evaluating colchicine vs usual care, and the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily vs usual care. The primary outcome for the colchicine randomization is need for high-flow oxygen, need for mechanical ventilation, or death, and for the rivaroxaban plus aspirin randomization, it is major thrombotic events, need for high-flow oxygen, need for mechanical ventilation, or death. Results: At the completion of enrollment on February 10, 2022, the outpatient trial had enrolled 3917 patients, and the inpatient trial had enrolled 2611 patients. Challenges encountered included lack of preliminary data about the interventions under evaluation, uncertainties related to the expected event rates, delays in regulatory and ethics approvals, and in obtaining study interventions, as well as the changing pattern of the COVID-19 pandemic. Conclusions: The ACT trials will determine the efficacy of antiinflammatory therapy with colchicine, and antithrombotic therapy with aspirin given alone or in combination with rivaroxaban, across the spectrum of mild, moderate, and severe COVID-19. Lessons learned from the conduct of these trials will inform planning of future trials.Contexte : Il est urgent de mettre au point des traitements efficaces contre la COVID-19, mais il n’est pas facile de realiser des essais à repartition aleatoire dans un contexte pandemique.Methodologie : Les essais internationaux factoriels ACT (Anti-Coronavirus Therapy) avaient un objectif d’inscription de 3 500 patients externes et de 2 500 patients hospitalises presentant une COVID-19 symptomatique. L’essai mene auprès de patients externes visait à evaluer la colchicine par rapport aux soins habituels, et l’aspirine par rapport aux soins habituels. Le paramètre d’evaluation principal au terme de la repartition aleatoire des patients etait l’hospitalisation ou le decès dans le groupe traite par la colchicine, et la thrombose majeure, l’hospitalisation ou le decès dans le groupe traite par l’aspirine. L’essai mene auprès de patients hospitalises visant à evaluer la colchicine par rapport aux soins habituels, et un traitement associant le rivaroxaban à 2,5 mg deux fois par jour et l’aspirine à 100 mg une fois par jour par rapport aux soins habituels. Le paramètre d’evaluation principal au terme de la repartition aleatoire des patients etait le recours à l’oxygenotherapie à haut debit ou à la ventilation mecanique ou le decès dans le groupe traite par la colchicine, et la survenue de manifestations thrombotiques majeures, le recours à l’oxyg enotherapie à haut debit ou à la ventilation m ecanique ou le decès dans le groupe traite par l’association rivaroxaban-aspirine. Resultats : À la fin de la periode d’inscription, le 10 fevrier 2022, 3 917 patients externes et 2 611 patients hospitalises formaient la population des essais. Certains aspects se sont reveles problematiques, notamment le manque de donnees preliminaires sur les interventions à evaluer, les incertitudes liees aux taux d´evenements prevus, les retards touchant les approbations reglementaires et ethiques et les interventions de recherche, de même que l’evolution de la pandemie de COVID-19. Conclusions : Les essais ACT d etermineront l’efficacite du traitement anti-inflammatoire par la colchicine et du traitement antithrombotique par l’aspirine, administree seule ou en association avec le rivaroxaban, contre la COVID-19 legère, moderee ou sevère. Les leçons tirees de ces essais orienteront la planification d’essais ulterieurs.Ciencias Médicas y de la Salud9 papplication/pdfhttps://doi.org/10.1016/j.cjco.2022.02.0102589-790X2589-790Xhttps://repositorio.udes.edu.co/handle/001/7446engUSA57665684John Eikelboom, Sumathy Rangarajan, Sanjit S. Jolly, Emilie P. Belley-Cote, Richard Whitlock, Heather Beresh, Gayle Lewis, Lizhen Xu, Noel Chan, Shrikant Bangdiwala, Rafael Diaz, Andres Orlandini, Mohamed Hassany, Wadea M. Tarhuni, A.M. Yusufali, Sanjib Kumar Sharma, Anna Kontsevaya, Patricio Lopez-Jaramillo, Alvaro Avezum, Antonio L. Dans, Sean Wasserman, Camilo Felix, Khawar Kazmi, Prem Pais, Denis Xavier, Renato D. Lopes, Otavio Berwanger, Menelas Nkeshimana, William Harper, Mark Loeb, Shurjeel Choudhri, Michael E. Farkouh, Jackie Bosch, Sonia S. Anand, Salim Yusuf, The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges, CJC Open, Volume 4, Issue 6, 2022, Pages 568-576, ISSN 2589-790X, https://doi.org/10.1016/j.cjco.2022.02.010. (https://www.sciencedirect.com/science/article/pii/S2589790X22000488)ScopusCJC Open© 2022 The Authors. Published by Elsevier Inc. on behalf of the Canadian Cardiovascular Society.info:eu-repo/semantics/openAccessAtribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0)https://creativecommons.org/licenses/by-nc-nd/4.0/http://purl.org/coar/access_right/c_abf2https://www.sciencedirect.com/science/article/pii/S2589790X22000488?via%3Dihub#!The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and ChallengesArtículo de revistahttp://purl.org/coar/resource_type/c_6501http://purl.org/coar/resource_type/c_2df8fbb1Textinfo:eu-repo/semantics/articlehttp://purl.org/redcol/resource_type/ARTinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/version/c_970fb48d4fbd8a85Todas las AudienciasPublicationORIGINALThe Anti-Coronavirus Therapies (ACT) Trials. Design, Baseline Characteristics, and Challenges.pdfThe Anti-Coronavirus Therapies (ACT) Trials. Design, Baseline Characteristics, and Challenges.pdfapplication/pdf271930https://repositorio.udes.edu.co/bitstreams/40abae68-9eaf-452c-bdcd-b02a57eeb81f/download5f6b408dc3015f60f4a2f76e41e8153aMD51LICENSElicense.txtlicense.txttext/plain; charset=utf-859https://repositorio.udes.edu.co/bitstreams/ff0d67e3-a56b-4361-82d2-de1d943c8f31/download38d94cf55aa1bf2dac1a736ac45c881cMD52TEXTThe Anti-Coronavirus Therapies (ACT) Trials. Design, Baseline Characteristics, and Challenges.pdf.txtThe Anti-Coronavirus Therapies (ACT) Trials. Design, Baseline Characteristics, and Challenges.pdf.txtExtracted texttext/plain5https://repositorio.udes.edu.co/bitstreams/325930dc-8a54-426b-b2dd-961f578d2c7c/download5dbe86c1111d64f45ba435df98fdc825MD53THUMBNAILThe Anti-Coronavirus Therapies (ACT) Trials. Design, Baseline Characteristics, and Challenges.pdf.jpgThe Anti-Coronavirus Therapies (ACT) Trials. Design, Baseline Characteristics, and Challenges.pdf.jpgGenerated Thumbnailimage/jpeg13151https://repositorio.udes.edu.co/bitstreams/7794c1f8-7bb5-4ab9-945c-bc981eeb8444/download8dc400efbb3752a52be209976a34469bMD54001/7446oai:repositorio.udes.edu.co:001/74462023-10-09 16:30:10.698https://creativecommons.org/licenses/by-nc-nd/4.0/© 2022 The Authors. Published by Elsevier Inc. on behalf of the Canadian Cardiovascular Society.https://repositorio.udes.edu.coRepositorio Universidad de Santandersoporte@metabiblioteca.comTGljZW5jaWEgZGUgUHVibGljYWNpw7NuIFVERVMKRGlyZWN0cmljZXMgZGUgVVNPIHkgQUNDRVNPCgo= |