Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial
Source: ClinicalTrials.gov NCT04472611 ↗Summary
Linked Publications (2)
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Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial.
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Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With COVID 19 Severity |
5; 4; 2; 0; 4; 1 | — |
Eligibility Criteria
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) 500ms narrow QRS 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
Data sourced from ClinicalTrials.gov (NCT04472611) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.