Men and women over 40 years of age, with a diagnosis of COVID-19 infection and at least one high risk criterion.
Conditions
Interventions
Trade Name: COLCHICINA SEID 0,5 mg comprimidos
Pharmaceutical Form:
INN or Proposed INN: COLCHICINE
CAS Number: 64-86-8
Other descriptive name: COLCHICINE
Concentration unit: mg milligram(s)
Concentr
Sponsors
MONTREAL HEART INSTITUTE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Man or woman over 40 years of age with the capacity and willingness to provide their informed consent. • Patient diagnosed with COVID-19 infection in the last 24 hours. • Outpatient (not currently hospitalized or pending decision on immediate hospitalization). • Patient presenting with at least one of the following high-risk criteria: Over 70 years of age, diabetes mellitus, uncontrolled hypertension (systolic blood pressure = 150 mm Hg), known respiratory disease (including asthma and chronic obstructive pulmonary disease) known heart failure Known coronary heart disease, fever = 38.4 ° C in the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or combination of high neutrophil count and low lymphocyte count. • Woman who is not fertile, defined as postmenopausal for at least 1 year or surgically sterile, or fertile woman who uses at least one contraceptive method, and preferably two complementary contraceptive methods including a barrier method (for example, male or female condom, spermicide, sponge, foam, gel, diaphragm, intrauterine device [IUD]) throughout the study and up to 30 days after the end of the study. • Patient with capacity and willingness to meet the requirements of this study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: • Hospitalized patient or pending decision on immediate hospitalization. • Patient in shock or with hemodynamic instability. • Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or with chronic diarrhea; • Patient with pre-existing progressive neuromuscular disease. • Cut-off point of estimated glomerular filtration rate (eGFR) with the MDRD equation <30 m / min / 1.73 m2 in all patients considered for inclusion. • Patient with a history of cirrhosis, active chronic hepatitis or severe liver disease. • Pregnant or lactating woman, or who is considering becoming pregnant during the study or in the 6 months following the last dose of study medication. • Patient who is already taking colchicine for other indications (the main chronic indications are familial Mediterranean fever and gout). Patients who have received colchicine treatment and discontinued it prior to inclusion do not require a period of pharmacological cleansing. • Patient with a history of allergic reaction or hypersensitivity to colchicine. • Patient receiving chemotherapy to treat cancer. • Patient who, for whatever reason, the researcher considers to be not a suitable candidate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to determine if short-term treatment with colchicine reduces the mortality rate and lung complications related to COVID-19.;Secondary Objective: The secondary objective is to determine the safety of colchicine treatment in this patient population.;Primary end point(s): The primary endpoint will be a composite endpoint of death or need for hospitalization from COVID-19 infection within 30 days of randomization.;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be the components of the composite primary endpoint and the need for mechanical ventilation within 30 days of randomization.;Timepoint(s) of evaluation of this end point: 30 days | — |
Countries
Spain
Contacts
Public ContactAlberto Borobia
Fundación investigación biomedica Hospital Universitario La Paz-UCICEC
Outcome results
None listed