Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trialResearch in context
Summary: Background: COVID-19 progression is associated with an increased risk of arterial and venous thrombosis. Randomised trials have demonstrated that anticoagulants reduce the risk of thromboembolism in hospitalised patients with COVID-19, but a benefit of routine anticoagulation has not been...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | EClinicalMedicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537023001815 |
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| author | Álvaro Avezum Haliton Alves Oliveira Junior Precil Diego M.M. Neves Lucas Bassolli O. Alves Alexandre B. Cavalcanti Regis G. Rosa Viviane C. Veiga Luciano C.P. Azevedo Sérgio Luiz Zimmermann Odilson Marcos Silvestre Raphael Cruz Seabra Prudente Adrian Paulo Morales Kormann Frederico Rafael Moreira Icaro Boszczowski Edgar de Brito Sobrinho André da Silva e Souza Renato Seligman Bruno de Souza Paolino Alvaro Razuk Audes Diogenes de Magalhaes Feitosa Pedro Luiz Monteiro Belmonte Priscila Freitas das Neves Gonçalves Mauro Esteves Hernandes Ariovaldo Leal Fagundes José Maria Sarmet Esteves Alexandre Pereira Tognon John Eikelboom Otávio Berwanger Renato D. Lopes Gustavo B.F. Oliveira |
| author_facet | Álvaro Avezum Haliton Alves Oliveira Junior Precil Diego M.M. Neves Lucas Bassolli O. Alves Alexandre B. Cavalcanti Regis G. Rosa Viviane C. Veiga Luciano C.P. Azevedo Sérgio Luiz Zimmermann Odilson Marcos Silvestre Raphael Cruz Seabra Prudente Adrian Paulo Morales Kormann Frederico Rafael Moreira Icaro Boszczowski Edgar de Brito Sobrinho André da Silva e Souza Renato Seligman Bruno de Souza Paolino Alvaro Razuk Audes Diogenes de Magalhaes Feitosa Pedro Luiz Monteiro Belmonte Priscila Freitas das Neves Gonçalves Mauro Esteves Hernandes Ariovaldo Leal Fagundes José Maria Sarmet Esteves Alexandre Pereira Tognon John Eikelboom Otávio Berwanger Renato D. Lopes Gustavo B.F. Oliveira |
| author_sort | Álvaro Avezum |
| collection | DOAJ |
| description | Summary: Background: COVID-19 progression is associated with an increased risk of arterial and venous thrombosis. Randomised trials have demonstrated that anticoagulants reduce the risk of thromboembolism in hospitalised patients with COVID-19, but a benefit of routine anticoagulation has not been demonstrated in the outpatient setting. Methods: We conducted a randomised, open-label, controlled, multicentre study, evaluating the use of rivaroxaban in mild or moderate COVID-19 patients. Adults ≥18 years old, with probable or confirmed SARS-CoV-2 infection, presenting within ≤7 days from symptom onset with no clear indication for hospitalization, plus at least 2 risk factors for complication, were randomised 1:1 either to rivaroxaban 10 mg OD for 14 days or to routine care. The primary efficacy endpoint was the composite of venous thromboembolic events, need of mechanical ventilation, acute myocardial infarction, stroke, acute limb ischemia, or death due to COVID-19 during the first 30 days. ClinicalTrials.gov: NCT04757857. Findings: Enrollment was prematurely stopped due to sustained reduction in new COVID-19 cases. From September 29th, 2020, through May 23rd, 2022, 660 patients were randomised (median age 61 [Q1-Q3 47–69], 55.7% women). There was no significant difference between rivaroxaban and control in the primary efficacy endpoint (4.3% [14/327] vs 5.8% [19/330], RR 0.74; 95% CI: 0.38–1.46). There was no major bleeding in the control group and 1 in the rivaroxaban group. Interpretation: On light of these findings no decision can be made about the utility of rivaroxaban to improve outcomes in outpatients with COVID-19. Metanalyses data provide no evidence of a benefit of anticoagulant prophylaxis in outpatients with COVID-19. These findings were the result of an underpowered study, therefore should be interpreted with caution. Funding: COALITION COVID-19 Brazil and Bayer S.A. |
| first_indexed | 2024-03-13T10:21:26Z |
| format | Article |
| id | doaj.art-0436d4040ad34bbaa82db009c3bfda8b |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-03-13T10:21:26Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj.art-0436d4040ad34bbaa82db009c3bfda8b2023-05-20T04:30:44ZengElsevierEClinicalMedicine2589-53702023-06-0160102004Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trialResearch in contextÁlvaro Avezum0Haliton Alves Oliveira Junior1Precil Diego M.M. Neves2Lucas Bassolli O. Alves3Alexandre B. Cavalcanti4Regis G. Rosa5Viviane C. Veiga6Luciano C.P. Azevedo7Sérgio Luiz Zimmermann8Odilson Marcos Silvestre9Raphael Cruz Seabra Prudente10Adrian Paulo Morales Kormann11Frederico Rafael Moreira12Icaro Boszczowski13Edgar de Brito Sobrinho14André da Silva e Souza15Renato Seligman16Bruno de Souza Paolino17Alvaro Razuk18Audes Diogenes de Magalhaes Feitosa19Pedro Luiz Monteiro Belmonte20Priscila Freitas das Neves Gonçalves21Mauro Esteves Hernandes22Ariovaldo Leal Fagundes23José Maria Sarmet Esteves24Alexandre Pereira Tognon25John Eikelboom26Otávio Berwanger27Renato D. Lopes28Gustavo B.F. Oliveira29International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil; Corresponding author. International Research Center, Hospital Alemão Oswaldo Cruz, Avenida Paulista 500 – 5th Floor, São Paulo, SP, 01310-000, Brazil.International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, BrazilInternational Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, BrazilInternational Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, BrazilHCOR Research Institute, São Paulo, BrazilHospital Moinhos de Vento, Porto Alegre, Brazil; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, BrazilBP–A Beneficência Portuguesa de São Paulo, São Paulo, BrazilHospital Sírio Libanês Research and Education Institute, São Paulo, BrazilClínica Procárdio Ltda, Blumenau, BrazilAcurácia Serviços Médicos – Eireli, Rio Branco, BrazilUnidade de Gestão e Promoção de Saúde-Prefeitura do Município de Jundiaí, BrazilMaestri e Kormann, Blumenau, BrazilInternational Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, BrazilInternational Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, BrazilHospital Adventista de Belém, BrazilHospital Santos Dumont Litoral Norte, Caraguatatuba, BrazilHospital de Clínicas de Porto Alegre, Porto Alegre, BrazilHospital São Lucas, Rio de Janeiro, BrazilInstituto Prevent Senior, São Paulo, BrazilPronto-Socorro Cardiológico Universitário de Pernambuco Prof. Luiz Tavares (PROCAPE), Recife, BrazilInstituto de Gestão Estratégica de Saúde do Distrito Federal. Brasília, BrazilSanta Casa de Misericórdia de Passos, Passos, BrazilSanta Casa de Misericórdia de Votuporanga, Votuporanga, BrazilHospital Universitário de Santa Maria, Santa Maria, BrazilNotreDame Intermédica Saúde, São Paulo, BrazilHospital São Vicente de Paulo, Passo Fundo, BrazilPopulation Health Research Institute, McMaster University, Hamilton, CanadaGeorge Institute for Global Health UK at Imperial College, London, United Kingdom; Hospital Israelita Albert Einstein, São Paulo, BrazilBrazilian Clinical Research Institute, São Paulo, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USAInternational Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, BrazilSummary: Background: COVID-19 progression is associated with an increased risk of arterial and venous thrombosis. Randomised trials have demonstrated that anticoagulants reduce the risk of thromboembolism in hospitalised patients with COVID-19, but a benefit of routine anticoagulation has not been demonstrated in the outpatient setting. Methods: We conducted a randomised, open-label, controlled, multicentre study, evaluating the use of rivaroxaban in mild or moderate COVID-19 patients. Adults ≥18 years old, with probable or confirmed SARS-CoV-2 infection, presenting within ≤7 days from symptom onset with no clear indication for hospitalization, plus at least 2 risk factors for complication, were randomised 1:1 either to rivaroxaban 10 mg OD for 14 days or to routine care. The primary efficacy endpoint was the composite of venous thromboembolic events, need of mechanical ventilation, acute myocardial infarction, stroke, acute limb ischemia, or death due to COVID-19 during the first 30 days. ClinicalTrials.gov: NCT04757857. Findings: Enrollment was prematurely stopped due to sustained reduction in new COVID-19 cases. From September 29th, 2020, through May 23rd, 2022, 660 patients were randomised (median age 61 [Q1-Q3 47–69], 55.7% women). There was no significant difference between rivaroxaban and control in the primary efficacy endpoint (4.3% [14/327] vs 5.8% [19/330], RR 0.74; 95% CI: 0.38–1.46). There was no major bleeding in the control group and 1 in the rivaroxaban group. Interpretation: On light of these findings no decision can be made about the utility of rivaroxaban to improve outcomes in outpatients with COVID-19. Metanalyses data provide no evidence of a benefit of anticoagulant prophylaxis in outpatients with COVID-19. These findings were the result of an underpowered study, therefore should be interpreted with caution. Funding: COALITION COVID-19 Brazil and Bayer S.A.http://www.sciencedirect.com/science/article/pii/S2589537023001815AnticoagulationCOVID-19OutpatientsRandomised clinical trial |
| spellingShingle | Álvaro Avezum Haliton Alves Oliveira Junior Precil Diego M.M. Neves Lucas Bassolli O. Alves Alexandre B. Cavalcanti Regis G. Rosa Viviane C. Veiga Luciano C.P. Azevedo Sérgio Luiz Zimmermann Odilson Marcos Silvestre Raphael Cruz Seabra Prudente Adrian Paulo Morales Kormann Frederico Rafael Moreira Icaro Boszczowski Edgar de Brito Sobrinho André da Silva e Souza Renato Seligman Bruno de Souza Paolino Alvaro Razuk Audes Diogenes de Magalhaes Feitosa Pedro Luiz Monteiro Belmonte Priscila Freitas das Neves Gonçalves Mauro Esteves Hernandes Ariovaldo Leal Fagundes José Maria Sarmet Esteves Alexandre Pereira Tognon John Eikelboom Otávio Berwanger Renato D. Lopes Gustavo B.F. Oliveira Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trialResearch in context EClinicalMedicine Anticoagulation COVID-19 Outpatients Randomised clinical trial |
| title | Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trialResearch in context |
| title_full | Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trialResearch in context |
| title_fullStr | Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trialResearch in context |
| title_full_unstemmed | Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trialResearch in context |
| title_short | Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trialResearch in context |
| title_sort | rivaroxaban to prevent major clinical outcomes in non hospitalised patients with covid 19 the care coalition viii randomised clinical trialresearch in context |
| topic | Anticoagulation COVID-19 Outpatients Randomised clinical trial |
| url | http://www.sciencedirect.com/science/article/pii/S2589537023001815 |
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