Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

Corona Virus Infection Clinical Trial

— COVID-19  

Official title:

Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04322682
• Other study ID #: MHIPS-2020-001
• Secondary ID: 3R01HL146206-02S
• Status: Terminated
• Phase: Phase 3
• Start date: March 23, 2020
• Est. completion date: January 21, 2021

Study information

• Verified date: September 2021
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.

Description:

The primary objective of this study is to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19. The secondary objective is to determine the safety of treatment with colchicine in this patient population.

Approximately 6000 patients will be enrolled to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.

Safety and efficacy will be based on data from randomized patients. An independent data and safety monitoring board (DSMB) will periodically review study results as well as the overall conduct of the study, and will make recommendations to the study Executive Steering Committee (ESC) to continue, stop or modify the study protocol.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4506
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Males and females, at least 40 years of age, capable and willing to provide informed consent;

2. Patient must have received a diagnosis of COVID-19 infection within the last 24 hours;

3. Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);

4. Patient must possess at least one of the following high-risk criteria: 70 years or more of age, obesity (BMI = 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure =150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, fever of =38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count;

5. Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;

6. Patient must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

1. Patient currently hospitalized or under immediate consideration for hospitalization;

2. Patient currently in shock or with hemodynamic instability;

3. Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;

4. Patient with pre-existent progressive neuromuscular disease;

5. Estimated Glomerular filtration rate (eGFR), using the MDRD equation for all subjects being considered for enrollment, with a cut-off of < 30 mL/m in/1.73m2;

6. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;

7. Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication;

8. Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout);

9. Patient with a history of an allergic reaction or significant sensitivity to colchicine;

10. Patient undergoing chemotherapy for cancer;

11. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections

Intervention

Drug:
• Colchicine
Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
• Placebo oral tablet
Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.

Locations

Country	Name	City	State
Brazil	Hospital Universitário Bragança Paulista	Bragança Paulista
Brazil	Instituto Cruzaltense de Cardiologia	Cruz Alta
Brazil	Hospital de Clínicas de Passo Fundo	Passo Fundo
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre
Brazil	Hospital Samaritano Higienópolis	São Paulo
Brazil	Instituto do Coração (InCor), School of Medicine, University of Sao Paulo	São Paulo	Sao Paulo
Canada	Montreal Heart Institute	Montreal	Quebec
Greece	University General Hospital of Athens "Attikon"	Chaïdári	Athens
Greece	General Hospital of Kozani "Mamatsio"	Kozáni
South Africa	Tread Research, Tygerberg Hospital	Cape Town
Spain	Hospital Universitario La Paz, IdiPaz	La Paz	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
United States	Centric Health Resources Inc.	Bakersfield	California
United States	Westside Medical Associates of Los Angeles	Beverly Hills	California
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Baylor Scott & White Research Institute - Pharmacy	Dallas	Texas
United States	University of Texas(UT) Southwestern Medical Center	Dallas	Texas
United States	Rancho Research Institute	Downey	California
United States	Spring Clinical Research	Houston	Texas
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	South Florida Research Organization	Medley	Florida
United States	Miami Center for Advanced Cardiology	Miami Beach	Florida
United States	New York Langone Health	New York	New York
United States	Mayo Clinic - Phoenix	Phoenix	Arizona
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	University of California San Francisco - Zuckerberg San Francisco General Hospital	San Francisco	California
United States	North Mississippi Medical Clinics, Inc.	Tupelo	Mississippi
United States	Yuma Regional Medical Center Cancer Center	Yuma	Arizona

Sponsors (5)

Lead Sponsor	Collaborator
Montreal Heart Institute	Bill and Melinda Gates Foundation, DACIMA Software, National Heart, Lung, and Blood Institute (NHLBI), The Government of Quebec

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Greece,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization in the Subgroup of Patients With PCR-confirmed COVID-19.	In the prespecified analysis of the 4159 patients with Covid-19 confirmed by PCR, the primary endpoint (composite of death or hospitalization due to Covid-19 infection in the 30 Days following randomization) was compared between the two treatment groups.	30 Days post randomization
Primary	Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.	The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization.	30 days post randomization
Secondary	Number of Deaths in the 30 Days Following Randomization.	The secondary endpoint consisted of two components of the composite primary endpoint and included death in the 30 days following randomization.	30 days post randomization
Secondary	Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.	The secondary endpoint consisted of two components of the composite primary endpoint and included hospitalization due to COVID-19 infection in the 30 days following randomization.	30 days post randomization
Secondary	Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization.	The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.	30 days post randomization