Covid-19 Living Data

Trial ISRCTN86534580
Publication PRINCIPLE - Dorward J, medRxiv (2021) (preprint)
Dates: 2021-03-04 to 2021-05-26
Funding: Public/non profit (UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / UK Follow-up duration (days): 28
Inclusion criteria	Aged ≥65 years, or 50-65 years with comorbidities ongoing symptoms from polymerase chain reaction (PCR) confirmed or suspected COVID-19 (high temperature and/or new, continuous cough and/or change in sense of smell/taste), which had started within the previous 14 days aged 18-65 years with comorbidities (heart disease hypertension asthma or lung disease diabetes hepatic impairment stroke or neurological problems weakened immune system e.g. chemotherapy and self-reported obesity or body mass index ≥35 kg/m2) or shortness of breath.
Exclusion criteria	Already taking colchicine or colchicine contraindicated according to the British National Formulary
Interventions
	Treatment Colchicine 500 mcg orally once a day for 14 days
	Control Standard care
Participants
	Randomized NR Analyzed 276 participants Colchicine=156 Standard care=120
	Characteristics of participants N= 276 Mean age : NR 145 males Severity : Mild: n= 314/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Hospital admission or mortality related to suspected COVID-19.
	In the report 1) time to first reported recovery defined as the first instance that a participant reports feeling recovered; and 2) hospitalisation or death related to COVID-19
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print article, the trial registry, protocol, statistical analysis plan and supplementary results were used in data extraction and assessment of risk of bias. The primary outcome indicated in registry does not reflect the primary outcome reported in the paper but is reflected in the protocol amendment. The article reports on a colchicine/usual care comparison that is part of an ongoing multi-treatment platform study. Results have been extracted for the population concurrently randomized to colchicine or usual care to mitigate the potential effect of temporal changes in risk. Recruitment to the colchicine arm was terminated after interim analysis revealed futility.