drugset / Trial / NCT04363437

COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19

NCT04363437

Phase 2 Terminated 21 enrolled Maimonides Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia and multiorgan failure. Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in hospitalized patients is approximately 20-25%. There is significant interest in therapies that can be given upstream to reduce the rate of mechanical ventilation and thus mortality. We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may decrease the risk of progression into ARDS requiring increased oxygen requirements, mechanical ventilation, and mortality.

Timeline

Start
2020-04-26
Primary completion
2020-07-31
Completion
2020-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colchicine Small molecule 0.6 mg Oral

Indications