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

NCT04472611 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2000027950
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

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

Conditions

SARS-CoV-2

Keywords

Rosuvastatin; Colchicine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With COVID 19 Severity

  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. Data presented is for Max WHO scores 5-8, indicating moderately to severely infected participants.

  30 Days

Study Arms (2)

Standard of Care (SOC) and Colchicine+Rosuvastatin

EXPERIMENTAL

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

Standard of care (SOC)

NO INTERVENTION

Patients will undergo standard of care treatment during hospitalization determined by the primary care team during hospitalization

Interventions

Standard of Care (SOC) and Colchicine+Rosuvastatin DRUG

Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization

Also known as: SOC & Colchicine and Rosuvastatin

Standard of Care (SOC) and Colchicine+Rosuvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (4)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Greenwich Hospital

Greenwich, Connecticut, 06807, United States

Location

Yale New Haven Hosptial System

New Haven, Connecticut, 06512, United States

Location

Lawrence & Memorial Hospital

New London, Connecticut, 06320, United States

Location

Related Publications (2)

• Shah T, McCarthy M, Nasir I, Archer H, Ragheb E, Kluger J, Kashyap N, Paredes C, Patel P, Lu J, Kandel P, Song C, Khan M, Huang H, Ul Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz C, Parise H, Lansky A. Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial. BMJ Open. 2023 Feb 24;13(2):e067910. doi: 10.1136/bmjopen-2022-067910.

  PMID: 36828654 DERIVED

• Shah T, McCarthy M, Nasir I, Archer H, Ragheb E, Kluger J, Kashyap N, Paredes C, Patel P, Lu J, Kandel P, Song C, Khan M, Ul Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz CS, Parise H, Lansky A. Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial. Contemp Clin Trials. 2021 Nov;110:106547. doi: 10.1016/j.cct.2021.106547. Epub 2021 Aug 28.

  PMID: 34461322 DERIVED

MeSH Terms

Interventions

Standard of Care; Colchicine; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Alkaloids; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Alexandra Lansky
• Organization: Yale University School of Medicine

alexandra.lansky@yale.edu

203 737 2142

Study Officials

• Alexandra Lansky, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 15, 2020
• Study Start: October 30, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 27, 2023
• Results First Posted: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)