Impact of Colchicine in Hospitalized Colombian Patients With COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of participants who die or require transfer to Intesive care unit
研究概览
简要总结
This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all inclusion and not inclusion criteria will be randomized to receive either Colchicine plus standard treatment or only standard treatment for 15 days
详细描述
Introduction
COVID-19 and mortality associated with acute respiratory distress syndrome (ARDS) pose a global public health problem. The increase in spread and associated mortality poses a scenario where cost-effective therapeutic options are urgently and effectively proposed to control and reduce the pandemic and even to reduce the number of deaths Objective: To evaluate the efficacy and safety of oral colchicine plus treatment standard versus standard treatment in the clinical course of SARS-CoV-2 virus infection, in a population group with moderate COVID-19 involvement and requiring hospitalization. Methodology: A prospective, open, randomized, parallel-group study, the sample size of 120 subjects each arm of 60 subjects. Random assignment (1: 1) to either colchicine plus standard treatment or control arm (standard treatment) orally for 14 days. An initial dose of 1.5 mg orally on the first day, followed by 0.5 mg every 12 hours on days 2 to 7 and continuing with 0.5 mg a day until completing 14 days ± 1. It will be followed on days 1, 3, 7, 14, and day 28, evaluating physical examination, clinical situation, laboratories, and adverse events. The primary efficacy data correspond to the deterioration in the clinical status of the patients through the semiquantitative ordinal scale suggested by the WHO R&D committee. Expected results: It is expected to find out how, through different pathways, colchicine could act in modulating or preventing the appearance of ARDS associated with COVID-19, its possible effects on viral replication and antigenic presentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
the sample size of 120 subjects each arm of 60 subjects. Random assignment (1: 1) to either colchicine plus standard treatment or control arm (standard treatment) orally for 14 days. An initial dose of 1.5 mg orally on the first day, followed by 0.5 mg every 12 hours on days 2 to 7 and continuing with 0.5 mg a day until completing 14 days ± 1. It will be followed on days 1, 3, 7, 14, and day 28, evaluating physical examination, clinical situation, laboratories, and adverse events. The primary efficacy data correspond to the deterioration in the clinical status of the patients through the semiquantitative ordinal scale suggested by the WHO R&D committee. Expected results: It is expected to find out how, through different pathways, colchicine could act in modulating or preventing
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old.
- •Laboratory-confirmed SARS-CoV-2 infection: infection confirmed with nasopharyngeal swab by positive RT PCR in the last 48 hours.
- •Hospital admission for COVID-19 in the previous 48 hours.
- •Clinical stage 3 (no supplemental oxygen requirement) or 4 (supplemental oxygen requirement for nasal contact lenses or mask) of the WHO classification (see ANNEX 2).
- •The patient must be able and willing to provide informed written consent before performing study procedures.
- •Patient confirmed to covid19 as positive by positive PCR test
排除标准
- •Pregnancy, nursing mothers, and women of childbearing potential who are unable to use adequate contraception.
- •Known hypersensitivity or other clear contraindication to the use of colchicine.
- •History of end-stage renal disease (eGFR <30 ml / min / 1.73 m2).
- •Medical history of cirrhosis (Child-Pugh C), liver failure, chronic active hepatitis, or severe liver disease defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 5 times the upper limit of normal.
- •History of pre-existing neuromuscular disease.
- •Previous severe hematologic disease or bleeding disorders.
- •Inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea, or malabsorptive syndrome.
- •Colchicine treatment for other indications.
- •Treatment with immunosuppressive/immunomodulatory agents, including glucocorticoids, antivirals, antimalarials, and IL 6 antagonists for 30 days prior to enrollment.
- •Use of other investigational drugs at the time of inclusion, or during the 30 days prior to inclusion.
- •Any medical condition or disease that, in the opinion of the investigator, may place the patient at unacceptable risk to participate in the study.
研究组 & 干预措施
COLHICINE PLUS STANDARD TREATMENT
Patients treated in the exposed group will consist of a decreasing dose of colchicine: a dose of 1.5 mg orally on the first day (initial 1 mg and 0.5 mg at 2 hours), followed by 0.5 mg every 12 hours on days 2 to 7, and continuing with 0.5 mg per day until completing 14 ± 1 days. The duration of treatment will be 14 ± 1 days, depending on the clinical judgment of the investigator.
干预措施: Colchicine 0.5 MG (Drug)
STANDARD TREATMENT
In this case, the centers where the patients will be included adhere to the Colombian guidelines (Colombian Consensus of the Colombian Association of Infectious Diseases), and to standard treatment
干预措施: CONTROL GROUP (Combination Product)
结局指标
主要结局
Number of participants who die or require transfer to Intesive care unit
时间窗: In the first 15 days after ramdomization
The primary endpoint will be the need of transfert to ICU or composite of dead due to COVID19 infection
次要结局
- Number of participants who die(15 days after ramdomization)