Colchicine in COVID-19: a Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Colchicine 1 MG Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine plus current care<br>Colchicine 0.5 mg three times a day if weight is less than 100 kg; 1 mg twice a day if weight is more than 100 kg for 30 days or up to discharge. Reduce based on gastrointestinal symptoms appearance at discretion of the Investigator. | Drug: Colchicine 1 MG Oral Tablet<br>* Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.<br>|
| No Intervention: Current care alone<br>Current care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of entering the critical stage | Comply with any of the followings: Respiratory failure occurs and requires mechanical ventilation; Patients combined with other organ failure need ICU monitoring and treatment Death | [1 month] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trend of White blood cell count |  | [up to 30 days] | 
| Change of the Sequential Organ failure Assessment (SOFA) |  | [up to 30 days] | 
| Rate of biochemical criterion (CK, ALT, ferritin) recovery |  | [up to 30 days] | 
| Rate of disease remission | Comply with any of the followings: No fever, cough and other symptoms; SPO2>94% or PaO2/FiO2 >350mmHg without oxygen inhalation | [up to 30 days] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, COVID-19, CORONAVIRUS, SARS-COV-2, COLCHICINE, IL-1