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Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial.
Dorward, Jienchi; Yu, Ly-Mee; Hayward, Gail; Saville, Benjamin R; Gbinigie, Oghenekome; Van Hecke, Oliver; Ogburn, Emma; Evans, Philip H; Thomas, Nicholas Pb; Patel, Mahendra G; Richards, Duncan; Berry, Nicholas; Detry, Michelle A; Saunders, Christina; Fitzgerald, Mark; Harris, Victoria; Shanyinde, Milensu; de Lusignan, Simon; Andersson, Monique I; Butler, Christopher C; Hobbs, Fd Richard.
Afiliação
  • Dorward J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
  • Yu LM; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Hayward G; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Saville BR; Berry Consultants, Texas, TX, US; Department of Biostatistics, Vanderbilt University School of Medicine, Tennessee, TN, US.
  • Gbinigie O; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Van Hecke O; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Ogburn E; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Evans PH; College of Medicine and Health, University of Exeter, Exeter, UK; National Institute for Health Research (NIHR) Clinical Research Network, NIHR, London, UK.
  • Thomas NP; NIHR, London; Royal College of General Practitioners, London, UK.
  • Patel MG; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Richards D; Oxford Clinical Trials Research Unit, Botnar Research Centre, University of Oxford, Oxford, UK.
  • Berry N; Berry Consultants, Texas, TX, US.
  • Detry MA; Berry Consultants, Texas, TX, US.
  • Saunders C; Berry Consultants, Texas, TX, US.
  • Fitzgerald M; Berry Consultants, Texas, TX, US.
  • Harris V; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Shanyinde M; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • de Lusignan S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Royal College of General Practitioners, London, UK.
  • Andersson MI; Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
  • Butler CC; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Hobbs FR; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Br J Gen Pract ; 72(720): e446-e455, 2022 07.
Article em En | MEDLINE | ID: mdl-35440469
ABSTRACT

BACKGROUND:

Colchicine has been proposed as a COVID-19 treatment.

AIM:

To determine whether colchicine reduces time to recovery and COVID-19-related admissions to hospital and/or deaths among people in the community. DESIGN AND

SETTING:

Prospective, multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial (PRINCIPLE).

METHOD:

Adults aged ≥65 years or ≥18 years with comorbidities or shortness of breath, and unwell for ≤14 days with suspected COVID-19 in the community, were randomised to usual care, usual care plus colchicine (500 µg daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery and admission to hospital/death related to COVID-19, within 28 days, analysed using Bayesian models.

RESULTS:

The trial opened on 2 April 2020. Randomisation to colchicine started on 4 March 2021 and stopped on 26 May 2021 because the prespecified time to recovery futility criterion was met. The primary analysis model included 2755 participants who were SARS-CoV-2 positive, randomised to colchicine (n = 156), usual care (n = 1145), and other treatments (n = 1454). Time to first self-reported recovery was similar in the colchicine group compared with usual care with an estimated hazard ratio of 0.92 (95% credible interval (CrI) = 0.72 to 1.16) and an estimated increase of 1.4 days in median time to self-reported recovery for colchicine versus usual care. The probability of meaningful benefit in time to recovery was very low at 1.8%. COVID-19-related admissions to hospital/deaths were similar in the colchicine group versus usual care, with an estimated odds ratio of 0.76 (95% CrI = 0.28 to 1.89) and an estimated difference of -0.4% (95% CrI = -2.7 to 2.4).

CONCLUSION:

Colchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Tratamento Farmacológico da COVID-19 Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans Idioma: En Revista: Br J Gen Pract Ano de publicação: 2022 Tipo de documento: Article País de afiliação: África do Sul
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Tratamento Farmacológico da COVID-19 Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans Idioma: En Revista: Br J Gen Pract Ano de publicação: 2022 Tipo de documento: Article País de afiliação: África do Sul