Colchicine in COVID-19: a Pilot Study
NCT04375202 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 227
Last updated 2022-11-07
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
University Of Perugia
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-18
- Primary Completion
- 2021-10-31
- Completion
- 2021-10-31
Countries
- Italy
Study Locations
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