Status:
COMPLETED
Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial
Lead Sponsor:
Yale University
Conditions:
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a pragmatic randomized open-label study of the safety and efficacy of the combination of colchicine and Rosuvastatin in addition to standard of care (SOC) compared to SOC alone in hospitalized...
Detailed Description
This is a prospective 1:1 randomized open-label clinical trial to investigate the safety and efficacy of the combination of Colchicine + Rosuvastatin added to standard of care (SOC) compared to SOC al...
Eligibility Criteria
Inclusion
- Inclusion Criteria 1.18 years or older and confirmed SARS-CoV-2 infection by RT-PCR 2. Patient is admitted to the floor (non-ICU) within 48 hours of hospital admission 3. The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided witnessed (by 2 independent members of the health care team) oral informed consent, or a photograph of the signed informed consent approved by the Institutional Review Board (IRB)
- Exclusion Criteria:
- Known pregnancy or nursing mothers
- Known allergy to statins or colchicine
- Patient is on chronic colchicine or oral corticosteroid treatment
- Acute liver disease defined by elevated transaminases (AST/ALT \> 3x ULN)
- Severe chronic kidney disease defined as glomerular filtration rate (GFR) \< 30mL/min1.73 m2
- Severe QTc prolongation (\>500ms narrow QRS\<120ms and \>550ms for wide QRS\>120)
- Presents with severe disease on admission (WHO ordinal scale of clinical improvement scores 5-8)
- Rhabdomyolysis or CPK \> 5x ULN
- Thrombocytopenia defined as platelet count \< 50,000 / mm3
- Leukopenia defined as white blood cell count \< 3000 ml
- Severe anemia defined as Hemoglobin value \<8 g/100ml
- Participation in any other clinical trial of an experimental treatment for COVID-19
Exclusion
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04472611
Start Date
October 30 2020
End Date
March 30 2022
Last Update
April 27 2023
Active Locations (4)
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1
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
2
Greenwich Hospital
Greenwich, Connecticut, United States, 06807
3
Yale New Haven Hosptial System
New Haven, Connecticut, United States, 06512
4
Lawrence & Memorial Hospital
New London, Connecticut, United States, 06320