COVID-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Control group: Patients in this group receive placebo tablets (containing oral calcium chloride, Caspian Pharmaceutical Company, Iran) for the first 3 days, twice a day, and then for t
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Require hospitalization. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team.;Severely ill. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team.;Death. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team. | — |
Secondary
| Measure | Time frame |
|---|---|
| Requiring mechanical ventilation. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team.;Incidence of severe complications, such as pulmonary fibrosis, prolonged illness, or malaise. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Barary
Babol University of Medical Sciences
Outcome results
None listed