Adding Colchicine to Tocilizumab in Patients With Severe COVID-19 Pneumonia.
Status:
Recruiting
Trial end date:
2022-08-30
Target enrollment:
Participant gender:
Summary
Colchicine acts upstream in the cytokines cascade by inhibiting the NLRP3 inflammasome while
IL-6 receptor antagonists (tocilizumab) block the end result of the cytokines cascade. Hence,
adding colchicine to tocilizumab with the aim of blocking the early and end products of the
cytokines cascade, might reduce the risk of developing cytokine storm and hence the need for
invasive mechanical ventilation and eventually death. Therefore, we aim to conduct an
open-label randomized controlled trial to evaluate the efficacy and safety of adding
colchicine to tocilizumab among patients with severe COVID-19 pneumonia in an attempt to
reduce the rate of invasive mechanical ventilation and mortality. We will include patients
with severe COVID-19 pneumonia and already received tocilizumab according to local protocol.
Enrolled patient will be then randomized in 1:1 to colchicine versus no colchicine. Patients
will be followed up until discharge or for 30 days, whichever comes first. Data will be
collected from electronic medical profiles. The primary efficacy outcome will be rate of
invasive mechanical ventilation and will be determined using Cox proportional hazard model.