Colchicine in COVID-19: a Pilot Study

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Of Perugia
• Treatments: Colchicine

Criteria

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