Colchicine in COVID-19: a Pilot Study (COLVID-19)

University Of Perugia

Status and phase: Terminated; Phase 2

Conditions: COVID-19

Treatments: Drug: Colchicine 1 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04375202

2020-001475-33

Details and patient eligibility

About

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.

Full 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.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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227 participants in 2 patient groups

Colchicine plus current care

Experimental group

Description:

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.

Treatment:

Drug: Colchicine 1 MG Oral Tablet

Current care alone

No Intervention group

Description:

Current care