Abstract
Some patients with COVID-19 pneumonia develop an associated cytokine storm syndrome that aggravates the pulmonary disease. These patients may benefit of anti-inflammatory treatment. The role of colchicine in hospitalized patients with COVID-19 pneumonia and established hyperinflammation remains unexplored. In a prospective, randomized controlled, observer-blinded endpoint, investigator-initiated trial, 240 hospitalized patients with COVID-19 pneumonia and established hyperinflammation were randomly allocated to receive oral colchicine or not. The primary efficacy outcome measure was a composite of non-invasive mechanical ventilation (CPAP or BiPAP), admission to the intensive care unit, invasive mechanical ventilation requirement or death. The composite primary outcome occurred in 19.3% of the total study population. The composite primary outcome was similar in the two arms (17% in colchicine group vs. 20.8% in the control group; p = 0.533) and the same applied to each of its individual components. Most patients received steroids (98%) and heparin (99%), with similar doses in both groups. In this trial, including adult patients with COVID-19 pneumonia and associated hyperinflammation, no clinical benefit was observed with short-course colchicine treatment beyond standard care regarding the combined outcome measurement of CPAP/BiPAP use, ICU admission, invasive mechanical ventilation or death (Funded by the Community of Madrid, EudraCT Number: 2020-001841-38; 26/04/2020).
【초록키워드】 Efficacy, Trial, intensive care, mechanical ventilation, Pneumonia, Cytokine storm syndrome, outcome, Randomized, hyperinflammation, Patient, ICU admission, death, Colchicine, Admission, pulmonary disease, Invasive mechanical ventilation, CPAP, dose, anti-inflammatory treatment, steroid, Non-invasive, Primary outcome, Endpoint, standard care, study population, components, clinical benefit, colchicine group, outcome measure, EudraCT, Arm, benefit, Randomly, colchicine treatment, develop, occurred, Most patient, applied, hospitalized patient, aggravate, receive, in both groups, investigator-initiated trial, observer-blinded, patients with COVID-19, with COVID-19, 【제목키워드】 randomized clinical trial, Severe COVID-19 pneumonia, moderate, colchicine treatment, hospitalized patient,