Colchicine in COVID-19: a Pilot Study (COLVID-19)
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Colchicine 1 MG Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID, COVID-19, CORONAVIRUS, SARS-COV-2, COLCHICINE, IL-1
Eligibility Criteria
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
Sites / Locations
- Associazione Italiana Pneumologi Ospedalieri
- Società Italiana di Reumatologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Colchicine plus current care
Current care alone
Arm Description
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.
Current care
Outcomes
Primary Outcome Measures
Rate of entering the critical stage
Comply with any of the followings:
Respiratory failure occurs and requires mechanical ventilation;
Patients combined with other organ failure need ICU monitoring and treatment
Death
Secondary Outcome Measures
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
Comply with any of the followings:
No fever, cough and other symptoms;
SPO2>94% or PaO2/FiO2 >350mmHg without oxygen inhalation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04375202
Brief Title
Colchicine in COVID-19: a Pilot Study
Acronym
COLVID-19
Official Title
Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient rate of patient accrual and newly available scientific evidence
Study Start Date
April 18, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Of Perugia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID, COVID-19, CORONAVIRUS, SARS-COV-2, COLCHICINE, IL-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colchicine plus current care
Arm Type
Experimental
Arm Description
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.
Arm Title
Current care alone
Arm Type
No Intervention
Arm Description
Current care
Intervention Type
Drug
Intervention Name(s)
Colchicine 1 MG Oral Tablet
Intervention Description
Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.
Primary Outcome Measure Information:
Title
Rate of entering the critical stage
Description
Comply with any of the followings:
Respiratory failure occurs and requires mechanical ventilation;
Patients combined with other organ failure need ICU monitoring and treatment
Death
Time Frame
[1 month]
Secondary Outcome Measure Information:
Title
Trend of White blood cell count
Time Frame
[up to 30 days]
Title
Change of the "Sequential Organ failure Assessment" (SOFA)
Time Frame
[up to 30 days]
Title
Rate of biochemical criterion (CK, ALT, ferritin) recovery
Time Frame
[up to 30 days]
Title
Rate of disease remission
Description
Comply with any of the followings:
No fever, cough and other symptoms;
SPO2>94% or PaO2/FiO2 >350mmHg without oxygen inhalation
Time Frame
[up to 30 days]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Associazione Italiana Pneumologi Ospedalieri
City
Milan
Country
Italy
Facility Name
Società Italiana di Reumatologia
City
Milan
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32317220
Citation
Perricone C, Triggianese P, Bartoloni E, Cafaro G, Bonifacio AF, Bursi R, Perricone R, Gerli R. The anti-viral facet of anti-rheumatic drugs: Lessons from COVID-19. J Autoimmun. 2020 Jul;111:102468. doi: 10.1016/j.jaut.2020.102468. Epub 2020 Apr 17.
Results Reference
background
PubMed Identifier
34658014
Citation
Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
Results Reference
derived
Links:
URL
https://www.aifa.gov.it/sperimentazioni-cliniche-covid-19
Description
Related Info
Learn more about this trial
Colchicine in COVID-19: a Pilot Study
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