Edoxaban and/or colchicine for patients with coronavirus disease 2019 managed in the out-of-hospital setting (CONVINCE): a randomized clinical trial

Abstract

The optimal pharmacological management of patients with Coronavirus disease 2019 (COVID-19) managed outside the hospital remains largely unsettled. In the investigator-initiated, open-label CONVINCE trial, 59 outpatients with COVID-19 were randomized (2 × 2 factorial design) to colchicine versus no treatment (anti-inflammatory comparison) or edoxaban versus no treatment (anticoagulation comparison). The study had two co-primary outcomes (one for each randomization): major vascular thrombotic events (MVTE, the composite of asymptomatic proximal deep vein thrombosis [DVT], symptomatic proximal or distal DVT, symptomatic pulmonary embolism or thrombosis, myocardial infarction, ischemic stroke, non-central nervous system embolism and death) at 25 ± 3 days for the anticoagulation comparison and the composite of SARS-CoV-2 detection rates or freedom from death or hospitalizations at 14 ± 3 days for the anti-inflammatory comparison. The trial was prematurely halted due to slow recruitment and availability of effective vaccines. Overall, 16 patients were randomized to edoxaban plus colchicine, 13 to edoxaban, 14 to colchicine and 16 to standard of care. The study showed no significant difference in the two co-primary outcomes with edoxaban and/or colchicine versus standard of care. However, these results should be interpreted in light of the low-risk profile of included patients and the premature termination of the trial.