Colchicine in COVID-19: a Pilot Study (COLVID-19)
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|ClinicalTrials.gov Identifier: NCT04375202|
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Colchicine 1 MG Oral Tablet||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||308 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study|
|Actual Study Start Date :||April 18, 2020|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||October 31, 2020|
Experimental: Colchicine plus current care
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
Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.
No Intervention: Current care alone
- Rate of entering the critical stage [ Time Frame: [1 month] ]
Comply with any of the followings:
- Respiratory failure occurs and requires mechanical ventilation;
- Patients combined with other organ failure need ICU monitoring and treatment
- 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 [ Time Frame: [up to 30 days] ]
Comply with any of the followings:
- No fever, cough and other symptoms;
- SPO2>94% or PaO2/FiO2 >350mmHg without oxygen inhalation
- Toxicity of Colchicine [ Time Frame: [up to 30 days] ]Rate of adverse events codified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375202
|Associazione Italiana Pneumologi Ospedalieri||Recruiting|
|Contact: Claudia Diana +39 0236590350 firstname.lastname@example.org|
|Società Italiana di Reumatologia||Recruiting|
|Contact: Carlo Scirè +390265560677 email@example.com|