COVID-19
Conditions
Keywords
COVID, COVID-19, CORONAVIRUS, SARS-COV-2, COLCHICINE, IL-1
Brief summary
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.
Detailed description
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care versus current care. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint. Secondary objectives are trend of White blood cell count, Change of the Sequential Organ failure Assessment (SOFA), Rate of biochemical criterion (CK, ALT,ferritin) recovery, Rate of disease remission and safety of Colchicine.
Interventions
Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent for participation in the study * Virological diagnosis of SARS-CoV-2 infection (real-time PCR) * Hospitalized due to clinical/instrumental diagnosis of pneumonia * Oxygen saturation at rest in ambient air ≤94% * PaO2/FiO2 ratio of 350 to 200
Exclusion criteria
* Known hypersensitivity to colchicine or its excipients * Severe diarrhea * Patients who cannot take oral therapy * Pregnant and lactating patients * Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) \<30 mL / min) * Patients with kidney or liver damage \[(AST or ALT\> 5 times the normal limits in International Units (ULN)\]; or are taking CYP3A4 enzyme - P glycoprotein inhibitors. * Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician * Neutrophils \<1.000 / mmc * Platelets \<50.000 / mmc * Bowel diverticulitis or perforation * Patients already in ICU or requiring mechanical ventilation * Patients receiving Tocilizumab * Patients already enrolled in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of entering the critical stage | [1 month] | Comply with any of the followings: 1. Respiratory failure occurs and requires mechanical ventilation; 2. Patients combined with other organ failure need ICU monitoring and treatment 3. Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Sequential Organ failure Assessment (SOFA) | [up to 30 days] | — |
| Rate of biochemical criterion (CK, ALT, ferritin) recovery | [up to 30 days] | — |
| Trend of White blood cell count | [up to 30 days] | — |
| Rate of disease remission | [up to 30 days] | Comply with any of the followings: 1. No fever, cough and other symptoms; 2. SPO2\>94% or PaO2/FiO2 \>350mmHg without oxygen inhalation |
Countries
Italy
Outcome results
None listed