Status:
TERMINATED
Colchicine in COVID-19: a Pilot Study
Lead Sponsor:
University Of Perugia
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 fai...
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 plu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT04375202
Start Date
April 18 2020
End Date
October 31 2021
Last Update
November 7 2022
Active Locations (2)
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1
Associazione Italiana Pneumologi Ospedalieri
Milan, Italy
2
Società Italiana di Reumatologia
Milan, Italy