Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19

Browse trials for

• Infections 6,687
• COVID-19 7,640

Keywords

• covid-19
• colchicine

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 752 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Lead sponsor

Biogipuzkoa Health Research Institute is the lead sponsor of 15 studies on the registry; 7 are open to participants now.

Study arms

• Active comparator
  Colchicine

  EC Experimental group: colchicine for 2 weeks orally added to standard treatment.

  Drug: Colchcine

• Placebo comparator
  Placebo

  Control group: placebo for 2 weeks added to standard treatment.

  Drug: Colchcine

Interventions

• DrugColchcine

  In patients not taking lopinavir / ritonavir or any other CYP3A4 or P-glycoprotein inhibitor drugs: * Day 1: 1 single dose of 1 mg orally, in a single dose. * Days 2 to 6: 0.5 mg every 12 hours v.o. * Days 7 to 14: 0.5 mg / 24 hours v.o. In patients taking drugs that inhibit the CYP3A4 system or the P-glycoprotein, these drugs will be attempted to be discontinued. The dose in these cases will be: o 0.5 mg every 72 hours v.o. while taking the drug that interacts. or 0.5 mg every 24 hours v.o. when, after suspending the interacting drug, at least 5 half-lives of the suspended drug have elapsed, from the last intake of said drug (in the case of lopinavir / ritonavir this would be a total of 24-30 hours) until the 14th day. In patients older than 80 years or patients with CKD-EPI estimated glomerular renal failure filtration rate between 30 and 50 ml / min / 1.73 m2), the colchicine / placebo dose will be: o Days 1 to 14: 0.5 mg / day

Primary outcomes

1. Proportion of patients who present death, need for mechanical ventilation or respiratory distress (Pa02 / FiO2 <300 or baseline O2 saturation ≤93%) on days +7, +14 and +30.

   Although the definition of respiratory distress usually includes a radiological criterion, as long as the oxygenation deficit is not attributable to another cause by the clinician, we do not consider it essential to perform a chest X-ray to confirm the diagnosis of distress because it does not correspond to clinical practice routine and the X-ray result does not change the patient's management.

   Time frame: 30 days (from day +1 to day +30)

2. Each of the items (proportion of patients who suffer death, need for mechanical ventilation and development of respiratory distress) separately on days +7, +14 and +30.

   Time frame: 30 days (from day +1 to day +30)

Secondary outcomes

1. Proportion of patients in each of the items of the clinical scale detailed below on days +3, +7, +14 and +30:

   1. Not hospitalized, usual activities not limited 2. Not hospitalized with limitation for usual activities 3. Hospitalized, without oxygen requirements 4. Hospitalized with oxygen requirements 5. Hospitalized with oxygen in a reservoir, non-invasive mechanical ventilation or high-flow oxygen device 6. Hospitalized with the need for invasive mechanical ventilation 7. Deceased

   Time frame: 30 days (from day +1 to day +30)

2. Time (days) until death

   Time frame: 30 days (from day +1 to day +30)

3. Proportion of patients in whom fever ≥37.8 ºC persists on days +3, +7, +14 and +30.

   Time frame: 30 days (from day +1 to day +30)

4. Evolution of the levels of C-Reactive Protein (CRP), LDH, D-dimer, ferritin, lymphocytes on days +3, +7, +14 and +30.

   Time frame: 30 days (from day +1 to day +30)

5. Proportion of patients who have received tocilizumab / other antiL6 or antiL1 drug / corticosteroids on days +3, +7, +14 and +30.

   Time frame: 30 days (from day +1 to day +30)

6. Proportion of patients experiencing serious unexpected adverse reactions that require discontinuation of the investigational product.

   Time frame: 30 days (from day +1 to day +30)

Individual participant data

Plan to share: No