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-GB

Lead Sponsor: Montreal Health Innovations Coordinating Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

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 and a positive SARS-CoV-2 with a valid COVID-19 test

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 or the combination of high neutrophil count and low lymphocyte count;

5.Only female patients who are not of child-bearing potential are eligible for inclusion. Women must either be postmenopausal for at least 1 year or surgically sterile (hysterectomy or bilateral salpingectomy);

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 enrolment with a cut off of <60ml/min/1.73m2 (Result must be obtained in the 60 days prior to the screening date)

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

7. Women of child bearing potential;

8. Patient who has ever taken 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.

Additional in UK:
12. Patient taking P-Glycoprotein inhibitors and strong CYP3A4 inhibitors at screening or 14 days previously will not be eligible for inclusion in the trial:
•P-Glycoprotein inhibitors such as ciclosporin, ranolazine, verapamil and quinidine
•Strong cytochrome P450 (CYP3A4) inhibitors including atazanavir, boceprevir, erythromycin, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, also darunavir, lopinavir and tipranavir when used in combination with ritonavir.
Please note the above lists are not exhaustive. See prescribing information for the UK for further information.

13.Patient with bicytopenia or pancytopenia

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

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