COLCHICINA TEST IN THE SARS-COV2 CORONAVIRUS (COLCORONA-COVID-19)

MONTREAL HEART INSTITUTE0 个研究点目标入组 1,000 人开始时间: 2020年4月13日最近更新: 2020年4月20日

适应症

试验速览

暂无简介。

•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

•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.

发起方

MONTREAL HEART INSTITUTE