Available Data

496 subjects, principally from the United States, are available in the data.

Objectives

To investigate the effect of colchicine on the composite of COVID-19-related death or hospital admission in community-treated patients.

Background

At the time of this study, evidence suggested that some patients with COVID-19 had excessive inflammation. Treatment of this inflammatory response was advocated to reduce the risk of complications. One study found that the steroid dexamethasone reduces mortality in patients admitted to hospital with COVID-19, but only if they receive mechanical ventilation or supplemental oxygen.

Outpatient treatment of inflammation due to COVID-19 requires a clinically available, orally administered, and inexpensive medication with a known favorable safety and tolerability profile. Colchicine is an anti-inflammatory medication used to treat gout, viral pericarditis, and coronary disease. Substantial clinical benefits of colchicine have also been reported in observational studies and two randomized controlled trials of patients admitted to the hospital with COVID-19. The COLCORONA study aimed to investigate the effect of colchicine on complications, including hospital admission and death, in community-treated patients with COVID-19.

Participants

Patients were eligible if they were at least 40 years of age, had received a diagnosis of COVID-19 within 24 h of enrollment, were not currently being treated in hospital and not under immediate consideration for hospital treatment or admission, and presented at least one of the following high-risk criteria: age of 70 years or older, obesity, diabetes, uncontrolled hypertension, known respiratory disease, known heart failure, known coronary disease, fever of at least 101⁰F within the last 48 h, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil and low lymphocyte counts.

Design

COLCORONA was a phase 3, randomized, double-blind, adaptive, placebo-controlled, multicenter study. The diagnosis of COVID-19 was made by local laboratories using PCR testing on a nasopharyngeal swab specimen. If PCR testing was not available, the diagnosis was based on an epidemiological link or symptoms.

All patients received either 0.5 mg colchicine orally administered twice per day for the first 3 days and then once per day for 27 days thereafter, or matching placebo.

Clinical evaluations occurred by telephone at 15 days and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.

The primary efficacy endpoint was a composite of death or hospital admission because of COVID-19 infection in the 30 days after randomization.

Conclusions

In conclusion, in community-treated patients including those without a mandatory diagnostic test, the effect of colchicine on COVID-19-related clinical events was not statistically significant. Among patients with PCR-confirmed COVID-19, colchicine led to a lower rate of the composite of death or hospital admission than placebo.

Tardif JC, Bouabdallaoui N, L'Allier PL, et al. Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial. Lancet Respir Med. 2021;9(8):924-932. doi:10.1016/S2213-2600(21)00222-8

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