Efficacy of colchicine in the treatment of COVID-19 patients

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Unit randomization is done by block method with a block size of 4. For each of the 6 possible scenarios for the quadruple block, the numbers are assigned as follows AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6). With the help of a dice, the numbers between 1 and 6 are selected, and the treatment allocation list is determined according to each number. To execute the generated random sequence, the method of hiding coded boxes or cans is used. In this method, the cans are numbered in a random sequence. Inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written is provided to the executor with the condition that the boxes are completely sealed. Finally, the researcher assigns patients to the standard intervention and treatment group based on patients' admission orders. Tools: Create random seq 2-3 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 < 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 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. COVID-19. COVID-19, virus identified;U07.1 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 the next 27 days, once a day. In addition to placebo, these participants will be prescribed the drugs listed in the National Covid-19 Treatment Protocol (including famotidine, cetirizine, N-acetylcysteine, bromhexine, naproxen, and fluticasone spray ). Intervention 2: Intervention group: Colchicine 0.5 mg tablets for the first 3 days, twice a day, and then for the next 27 days, once a day. In this group, in addition to colchicine, people will be prescribed drugs listed in the national protocol for the treatment of Covid-19 disease (including famotidine, cetirizine, N-acetylcysteine, bromhexine, naproxen, and fluticasone spray ). 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. 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.
Epistemonikos ID: 6bf57869f7bb5a27cb98526d79192a9556dec667
First added on: Jun 21, 2021