Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

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. The
      investigators present a randomized, controlled, open-labeled, and pragmatic clinical trial to
      study the treatment effect of Colchicine in COVID-19 patients requiring hospitalization, but
      no intensive care yet. Colchicine will be started within the first 48 hours and continue for
      14 days using a descending dose. The benefits will be studied 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 affordable and widely accessible which would help to prevent the
      inflammatory complications associated with COVID-19.
    

Detailed description: 
      This is a Phase III, prospective, pragmatic, randomized, controlled and open-label trial,
      comparing standard of care vs. standard of care plus COLCHICINE for 14 days, in patients
      hospitalized due to COVID-19 and confirmed infection by SARS-CoV-2, within the first 48 hours
      after the hospital admission. Patients meeting severity criteria will be excluded, defined as
      established limitation of therapeutic effort or need for invasive mechanical ventilation at
      the time of inclusion. The Colchicine treatment includes an initial dose of 1.5 mg (1 mg and
      0.5 mg two hours after), followed by 0.5 mg every 12 hours during the next 7 days and 0.5 mg
      every 24 hours until the completion of 14 days of total treatment. In patients receiving
      ritonavir or lopinavir or with reduced renal clearance (<50 ml/min/1.37m2), weight <70 kg or
      age >75 years old, the dose will be adjusted to the half.

      Patients meeting all the inclusion criteria and none of the exclusion ones (see below), after
      signing the informed consent, will be centrally randomized to "Colchicine" or "Control"
      group. Patients in both groups will receive the standard therapy for COVID-19 as per the
      hospital protocols. Randomization will be controlled by: age, sex, time from initiation of
      symptoms, cardiovascular disease, the 7 point WHO and levels of C-reactive protein, ferritin,
      D-dimer, IL-6 and lymphocyte levels.
    

Intervention name(s): Colchicine; Standard COVID-19 care
Intervention type(s): Drug; Drug
Intervention description(s): Colchicine tablet 0.5 mg; As per the hospital guidelines
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase III, prospective, randomized, controlled, open-label and pragmatic trial, comparing the administration of Colchicine plus standard treatment vs. standard therapy, in hospitalized patients with COVID-19, within the first 48 hours, and no severity criteria.
Masking: None (Open Label)
Primary purpose: Treatment