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Colchicine and aspirin in community patients with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial.
Eikelboom, John W; Jolly, Sanjit S; Belley-Cote, Emilie P; Whitlock, Richard P; Rangarajan, Sumathy; Xu, Lizhen; Heenan, Laura; Bangdiwala, Shrikant I; Tarhuni, Wadea M; Hassany, Mohamed; Kontsevaya, Anna; Harper, William; Sharma, Sanjib Kumar; Lopez-Jaramillo, Patricio; Dans, Antonio L; Palileo-Villanueva, Lia M; Avezum, Alvaro; Pais, Prem; Xavier, Denis; Felix, Camilo; Yusufali, Afzalhussein; Lopes, Renato D; Berwanger, Otavio; Ali, Zeeshan; Wasserman, Sean; Anand, Sonia S; Bosch, Jackie; Choudhri, Shurjeel; Farkouh, Michael E; Loeb, Mark; Yusuf, Salim.
  • Eikelboom JW; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada. Electronic address: eikelbj@mcmaster.ca.
  • Jolly SS; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.
  • Belley-Cote EP; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.
  • Whitlock RP; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada; Department of Surgery, McMaster University, Hamilton, ON, Canada.
  • Rangarajan S; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada.
  • Xu L; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada.
  • Heenan L; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada.
  • Bangdiwala SI; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.
  • Tarhuni WM; Department of Medicine, University of Saskatchewan, Saskatoon, SK, Canada; Department of Medicine, Western University, Clinical Skills Building London, ON, Canada; Windsor Cardiac Centre, Windsor, ON, Canada.
  • Hassany M; National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
  • Kontsevaya A; National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia.
  • Harper W; Department of Medicine, McMaster University, Hamilton, ON, Canada.
  • Sharma SK; BP Koirala Institute of Health Sciences, Dharan, Nepal.
  • Lopez-Jaramillo P; Masira Research Institute, Medical School, Universidad de Santander, Bucaramanga, Colombia.
  • Dans AL; UP College of Medicine, University of the Philippines Manila, Manila, Philippines.
  • Palileo-Villanueva LM; UP College of Medicine, University of the Philippines Manila, Manila, Philippines.
  • Avezum A; International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.
  • Pais P; St John's Research Institute, Bangalore, India.
  • Xavier D; St John's Medical College, St John's Research Institute, Bangalore, India.
  • Felix C; Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Ecuador.
  • Yusufali A; Hatta Hospital, Dubai Medical College, Dubai Health Authority, Dubai, United Arab Emirates.
  • Lopes RD; Division of Cardiology, Duke University Medical Center, Duke Clinical Research Institute, NC, USA.
  • Berwanger O; Hospital Israelita Albert Einstein, São Paulo, Brazil.
  • Ali Z; Jinnah Sindh Medical University and Jinnah Postgraduate Medical Center, Karachi, Pakistan.
  • Wasserman S; Wellcome Centre for Infectious Diseases Research in Africa, Institute for Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa; Division of Infectious Diseases and HIV Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
  • Anand SS; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.
  • Bosch J; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada; School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada.
  • Choudhri S; Bayer, Medical & Scientific Affairs, Mississauga, ON, Canada.
  • Farkouh ME; Peter Munk Cardiac Centre, University of Toronto, Toronto, ON, Canada.
  • Loeb M; Departments of Pathology and Molecular Medicine and Health Evidence Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
  • Yusuf S; Population Health Research Institute, McMaster University and Hamilton Health Sciences Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.
Lancet Respir Med ; 10(12): 1160-1168, 2022 Dec.
Статья в английский | MEDLINE | ID: covidwho-2062045
ABSTRACT

BACKGROUND:

The large number of patients worldwide infected with the SARS-CoV-2 virus has overwhelmed health-care systems globally. The Anti-Coronavirus Therapies (ACT) outpatient trial aimed to evaluate anti-inflammatory therapy with colchicine and antithrombotic therapy with aspirin for prevention of disease progression in community patients with COVID-19.

METHODS:

The ACT outpatient, open-label, 2 × 2 factorial, randomised, controlled trial, was done at 48 clinical sites in 11 countries. Patients in the community aged 30 years and older with symptomatic, laboratory confirmed COVID-19 who were within 7 days of diagnosis and at high risk of disease progression were randomly assigned (11) to receive colchicine 0·6 mg twice daily for 3 days and then 0·6 mg once daily for 25 days versus usual care, and in a second (11) randomisation to receive aspirin 100 mg once daily for 28 days versus usual care. Investigators and patients were not masked to treatment allocation. The primary outcome was assessed at 45 days in the intention-to-treat population; for the colchicine randomisation it was hospitalisation or death, and for the aspirin randomisation it was major thrombosis, hospitalisation, or death. The ACT outpatient trial is registered at ClinicalTrials.gov, NCT04324463 and is ongoing.

FINDINGS:

Between Aug 27, 2020, and Feb 10, 2022, 3917 patients were randomly assigned to colchicine or control and to aspirin or control; after excluding 36 patients due to administrative reasons 3881 individuals were included in the analysis (n=1939 colchicine vs n=1942 control; n=1945 aspirin vs 1936 control). Follow-up was more than 99% complete. Overall event rates were 5 (0·1%) of 3881 for major thrombosis, 123 (3·2%) of 3881 for hospitalisation, and 23 (0·6%) of 3881 for death; 66 (3·4%) of 1939 patients allocated to colchicine and 65 (3·3%) of 1942 patients allocated to control experienced hospitalisation or death (hazard ratio [HR] 1·02, 95% CI 0·72-1·43, p=0·93); and 59 (3·0%) of 1945 of patients allocated to aspirin and 73 (3·8%) of 1936 patients allocated to control experienced major thrombosis, hospitalisation, or death (HR 0·80, 95% CI 0·57-1·13, p=0·21). Results for the primary outcome were consistent in all prespecified subgroups, including according to baseline vaccination status, timing of randomisation in relation to onset of symptoms (post-hoc analysis), and timing of enrolment according to the phase of the pandemic (post-hoc analysis). There were more serious adverse events with colchicine than with control (34 patients [1·8%] of 1939 vs 27 [1·4%] of 1942) but none in either group that led to discontinuation of study interventions. There was no increase in serious adverse events with aspirin versus control (31 [1·6%] vs 31 [1·6%]) and none that led to discontinuation of study interventions.

INTERPRETATION:

The results provide no support for the use of colchicine or aspirin to prevent disease progression or death in outpatients with COVID-19.

FUNDING:

Canadian Institutes for Health Research, Bayer, Population Health Research Institute, Hamilton Health Sciences Research Institute, and Thistledown Foundation. TRANSLATIONS For the Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section.
Тема - темы

Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: Thrombosis / COVID-19 Тип исследования: Когортное исследование / Экспериментальные исследования / Прогностическое исследование / Рандомизированные контролируемые испытания Темы: Вакцина Пределы темы: Люди Страна как тема: Северная Америка Язык: английский Журнал: Lancet Respir Med Год: 2022 Тип: Статья

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Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: Thrombosis / COVID-19 Тип исследования: Когортное исследование / Экспериментальные исследования / Прогностическое исследование / Рандомизированные контролируемые испытания Темы: Вакцина Пределы темы: Люди Страна как тема: Северная Америка Язык: английский Журнал: Lancet Respir Med Год: 2022 Тип: Статья