Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial
In patients ≥40 with Covid-19 and ≥1 high-risk characteristic (n=4488), colchicine (0.5mg twice daily for 3 days, then once daily for 27 days) was not associated with a statistically significant reduction in death or Covid-19 hospital admission (4.7% v 5.8% placebo; p=0.081).
Source:
The Lancet Respiratory Medicine
SPS commentary:
Patients were eligible for inclusion in this trial if they had received a diagnosis of COVID-19 within 24 h of enrolment and presented with at least one of the following high-risk criteria: age of 70 years or older, obesity (BMI of 30 kg/m2 or more), diabetes, uncontrolled hypertension (systolic BP ≥150 mmHg), known respiratory disease, known heart failure, known coronary disease, fever of at least 38·4°C within the last 48 h, dyspnoea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil and low lymphocyte counts.
The primary endpoint, a composite of death or hospital admission due to Covid-19, occurred in 104 (4.7%) of 2235 patients in the colchicine group and 131 (5.8%) of 2253 patients in the placebo group (odds ratio 0.79, 95·1% CI 0.61–1.03; p=0.081). In those with PCR-confirmed Covid-19, the results for this endpoint were statistically significant (4.6% v 6.0%; OR 0.75, 0.57–0.99; p=0.042).
NICE updated its managing Covid-19 rapid guideline (NG191) on 27 May to include new recommendations on the use of colchicine to treat Covid-19, as follows:
- Do not offer colchicine to people in hospital to treat COVID-19.
- Only use colchicine to treat COVID-19 in community settings as part of a clinical trial (this was based on the results of this study, when available as a preprint)
The guideline notes that there was no statistically significant effect 30 days after starting colchicine treatment compared with placebo for the critical outcomes of mortality [0.2% v 0.4% placebo; OR 0.56; 95% CI 0.19-1.67) and need for mechanical ventilation (0.5% v 0.9%; 0.53; 95% CI 0.25-1.09). The certainty of evidence for these outcomes is considered low because of very serious imprecision in that only one study was identified, there were few events and confidence intervals were wide.
NICE recommends that further research should be carried out in community settings to see whether colchicine might yet be an effective treatment.