COVID-19 trials registries data warehouse

http://en.irct.ir/trial/56624

Reza Ghadimi

rezaghadimi@yahoo.com

2021-06-21

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Men and women of at least 18 years of age capable of providing informed consent. Confirmation of COVID-19 with RT-PCR in the last 24 hours Patients with outpatient treatment status (do not have any of the following): PaO2/FiO2 < 300, SpO2 < 93%, Respiratory rate > 30, Progressive lung involvements in CT scan The patient must meet at least one of the following high-risk criteria: 70 years of age or older, obesity (BMI ≥ 30 kg/m2), diabetes, uncontrolled blood pressure (systolic blood pressure > 150 mm Hg), known case of respiratory disease (Including asthma or COPD), known case of heart failure, known case of coronary artery disease, fever > 38.4°C in the last 48 hours, shortness of breath at the time of enrollment, Bicytopenia, Pancytopenia or a combination of neutrophilia and lymphopenia

The patient is currently hospitalized or needs immediate care and hospitalization. Showing any symptoms of shock or hemodynamic instability. History of inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption. History of progressive neuromuscular disease. Estimated glomerular filtration rate (eGFR) < 30 ml/min in 1.73 m2 using MDRD equation. History of cirrhosis, chronic active hepatitis or severe liver disease. Pregnant, breastfeeding, or women Intending to get pregnant during the study period or 6 months after the last dose of study agent. History of colchicine use for other conditions, including Familial Mediterranean Fever or gout. History of allergic reaction or severe sensitivity to colchicine. Cancer patients undergoing active chemotherapy.

2

Babol University of Medical Sciences

18

100

Iran

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

500

Require hospitalization Severely ill Death

Phase 2/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"}]