Trial to Study the Benefit of Colchicine in Patients With COVID-19
Status:
Completed
Trial end date:
2020-12-30
Target enrollment:
Participant gender:
Summary
COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan
failure and elevated mortality. Oral colchicine exhibits high anti-inflammatory capacity
attributed to the inhibition of microtubules polymerization, inflammasome and production of
IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. We
present a randomized clinical trial, controlled, open-label and pragmatic, including COVID-19
patients requiring hospitalization but no intensive care yet. Colchicine will be started
within the first 48 hours and then administered for four weeks using a descending dose. The
benefit will be study in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as
well as other clinical and biochemical secondary end-points. In the case of positive results,
the clinical impact would be relevant given that this oral medication is widely accessible
which would help to prevent the inflammatory complications associated with COVID-19.
Phase:
Phase 3
Details
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia