COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04322682

Jean-Claude Tardif

jean-claude.tardif@icm-mhi.org

2020-03-26

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: males and females, at least 40 years of age, capable and willing to provide informed consent; patient must have received a diagnosis of covid-19 infection within the last 24 hours; outpatient setting (not currently hospitalized or under immediate consideration for hospitalization); 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, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count; female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (iud)) throughout the study and for 30 days after study completion; patient must be able and willing to comply with the requirements of this study protocol.

patient currently hospitalized or under immediate consideration for hospitalization; patient currently in shock or with hemodynamic instability; patient with inflammatory bowel disease (crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption; patient with pre-existent progressive neuromuscular disease; 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; patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease; female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication; patient currently taking colchicine for other indications (mainly chronic indications represented by familial mediterranean fever or gout); patient with a history of an allergic reaction or significant sensitivity to colchicine; patient undergoing chemotherapy for cancer; patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

2

Montreal Heart Institute

40

None

Brazil;Canada;Greece;South Africa;Spain;United States

No restriction on type of patients

0: No restriction on type of patients

4506

Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.

None

Phase 3

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]