A Phase 2 interventional study of Colchicine 1 MG Oral Tablet in COVID-19, sponsored by University Of Perugia. Terminated at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-07.
Sponsored by University Of Perugia · Phase 2, Interventional, and Treatment
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 227 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University Of Perugia is the lead sponsor of 54 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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.
Drug: Colchicine 1 MG Oral Tablet
Current care
Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.
Rate of entering the critical stage
Comply with any of the followings: 1. Respiratory failure occurs and requires mechanical ventilation; 2. Patients combined with other organ failure need ICU monitoring and treatment 3. Death
Time frame: [1 month]
Trend of White blood cell count
Time frame: [up to 30 days]
Change of the "Sequential Organ failure Assessment" (SOFA)
Time frame: [up to 30 days]
Rate of biochemical criterion (CK, ALT, ferritin) recovery
Time frame: [up to 30 days]
Rate of disease remission
Comply with any of the followings: 1. No fever, cough and other symptoms; 2. SPO2\>94% or PaO2/FiO2 \>350mmHg without oxygen inhalation
Time frame: [up to 30 days]
Plan to share: No
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Colchicine
University Of Perugia