COVID-19 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Colchicine
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Colchicine
CAS Number: 64-86-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Sponsors
Montreal Health Innovations Coordinating Centre
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| 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 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 | — |
Countries
Brazil, Canada, Greece, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactBassevitch
Montreal Health Innovations Coordinating Centre
Outcome results
None listed