Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial

Completed · Phase 3

Conditions studied: SARS-CoV-2

In brief

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 patients with SARS-CoV-2

Key facts

Study ID

NCT04472611

Run by

Yale University

People needed

250

Starts

2020-10-30

Expected to finish

2022-03-30

Last updated by the study team

2023-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Greenwich Hospital — Greenwich, Connecticut, United States
• Yale New Haven Hosptial System — New Haven, Connecticut, United States
• Lawrence & Memorial Hospital — New London, Connecticut, United States

Full record on ClinicalTrials.gov

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