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.
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.
Drug: Colchicine 1 MG Oral Tablet
Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.
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
Associazione Italiana Pneumologi Ospedalieri
Milan, Italy
Società Italiana di Reumatologia
Milan, Italy