Overview

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

Status:
Recruiting

Trial end date:
2022-08-01

Target enrollment:
0

Participant gender:
All

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 patients with SARS-CoV-2

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yale University

Treatments:

Colchicine
Rosuvastatin Calcium

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:

1. Known pregnancy or nursing mothers

2. Known allergy to statins or colchicine

3. Patient is on chronic colchicine or oral corticosteroid treatment

4. Acute liver disease defined by elevated transaminases (AST/ALT > 3x ULN)

5. Severe chronic kidney disease defined as glomerular filtration rate (GFR) <
30mL/min1.73 m2

6. Severe QTc prolongation (>500ms narrow QRS<120ms and >550ms for wide QRS>120)

7. Presents with severe disease on admission (WHO ordinal scale of clinical improvement
scores 5-8)

8. Rhabdomyolysis or CPK > 5x ULN

9. Thrombocytopenia defined as platelet count < 50,000 / mm3

10. Leukopenia defined as white blood cell count < 3000 ml

11. Severe anemia defined as Hemoglobin value <8 g/100ml

12. Participation in any other clinical trial of an experimental treatment for COVID-19