Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial.
Br J Gen Pract
; 72(720): e446-e455, 2022 07.
Artículo
en Inglés
| MEDLINE | ID: covidwho-1924323
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 ANDSETTING:
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.Palabras clave
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Base de datos:
MEDLINE
Asunto principal:
Tratamiento Farmacológico de COVID-19
Tipo de estudio:
Estudio de cohorte
/
Estudio experimental
/
Estudio observacional
/
Estudio pronóstico
/
Ensayo controlado aleatorizado
Límite:
Adulto
/
Humanos
Idioma:
Inglés
Revista:
Br J Gen Pract
Año:
2022
Tipo del documento:
Artículo
País de afiliación:
BJGP.2022.0083
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