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

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ClinicalTrials.gov Identifier: NCT04472611
Recruitment Status : Not yet recruiting
First Posted : July 15, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

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 patients with SARS-CoV-2

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Drug: Standard of Care (SOC) and Colchicine+Rosuvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard of Care (SOC) and Colchicine+Rosuvastatin
Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
Drug: Standard of Care (SOC) and Colchicine+Rosuvastatin
Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization

No Intervention: Standard of care (SOC)
Patients will undergo standard of care treatment during hospitalization determined by the primary care team during hospitalization



Primary Outcome Measures :
  1. COVID 19 Severity [ Time Frame: 30 Days ]
    As defined by World Health Organization Ordinal Scale, which ranges from 1 to 8. Severity of COVID measured by WHO Scores 5-8: Defined as 5= Hospitalized requiring including CPAP, face mask, high flow nasal cannula (Excludes regular nasal cannula) 6= Hospitalized requiring intubation and mechanical ventilation 7= Hospitalized requiring mechanical ventilation and additional organ support (vasopressors, renal replacement therapy, ECMO) 8= Death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04472611


Contacts
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Contact: Marianne McCarthy, MBA 2037853346 Marianne.mccarthy@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hosptial System
New Haven, Connecticut, United States, 06512
Principal Investigator: Alexandra Lansky, MD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Alexandra Lansky, MD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04472611    
Other Study ID Numbers: 2000027950
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
Rosuvastatin
Colchicine
Additional relevant MeSH terms:
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Colchicine
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents