COLCHICINE STUDY IN THE SARS-COV2 CORONAVIRUS (COLCORONA-COVID-19)

Phase 1

Conditions: COVID-19
MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2020-001689-12-FR

Lead Sponsor: Montreal Heart Institute Coordinating Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 6000

Inclusion Criteria

All of these criteria must be met:

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, dyspnoea 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;

6. Patient must be able and willing to comply with the requirements of this study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

None of these exclusion criteria should be met:
1. Patient currently hospitalized or under immediate consideration for hospitalization;

2. Patient currently in shock or with haemodynamic instability;

3. Patient with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or patient with chronic diarrhoea;

4. Patient with pre-existenting 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. Women of child bearing potential;

8. Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout). There is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment;

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: The secondary objective is to determine the safety of treatment with colchicine in this patient population. <br><br>The exploratory objective is to evaluate links between soluble and genetic biomarkers and treatment effects. ;Primary end point(s): The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.;Timepoint(s) of evaluation of this end point: 30 days after randomisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints will consist of the components of the primary endpoint, and the need for mechanical ventilation in the 30 days post randomisation<br><br>Exploratory endpoints will include associations between both biomarkers and viral load and treatment effects;Timepoint(s) of evaluation of this end point: 30 days post randomisation

Related Trials