PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Number of participants who die due to COVID-19 infection
研究概览
简要总结
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.
详细描述
The primary objective of the study is to determine whether short term course of colchicines reduces number of deaths due to COVID-19 and severe complications due to the virus in elderly patients with comorbidities.
The secondary objective is to determine the safety of colchicines in this patient population.
Approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio) during 21 days. Follow-up assessments will occur every 48 hours and always at day 10, 21 and 61 following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes who are at least 60 years old.
- •Diagnosis of COVID-19 infection in the last 72 hours and confirmed by PCR
- •Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences
- •The patient must possess at least two of the following high-risk criteria
- •60 years of age or older AND
- •Any of the following: Diabetes mellitus, high blood pressure, known pulmonary disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia, pancytopenia, or the existence of simultaneous neutrophilia and lymphopenia
- •The patient must be able and willing to comply with the requirements of this study protocol.
排除标准
- •Hospitalized patient or under immediate consideration of doing so
- •Patient taking colchicine for other indications
- •Patient with history of allergic reaction or sensitivity to colchicine
- •Patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or malabsorption
- •Patient with pre-existing progressive neuromuscular disease
- •Patient with kidney damage and estimated glomerular filtrate rate <30 ml/m at 1732
- •Patient undergoing chemotherapy for cancer, including haematological malignancies.
- •Patients being treated with CYP3A4 and/or glycoprotein inhibitor drugs
- •Immunosuppressive treatment
- •History of cirrhosis, chronic active hepatitis, severe chronic disease defined by GOT or GPT values exceeding 3 times the upper limit of normal.
- •If the investigator considers it, for any reason, to be an inadequate candidate.
- •Patient and/or legal representative will not have signed the informed consent form.
研究组 & 干预措施
Colchicine plus symptomatic treatment (paracetamol).
Patients in this arm will receive study medication colchicines 0.5 mg orally (PO) twice daily for the first 3 days and then once daily for the last 18 days. If a dose is missed, it should not be replaced.
All patients should also receive best symptomatic treatment (mainly paracetamol), based on clinical practice.
干预措施: Colchicine plus symptomatic treatment (paracetamol) (Drug)
Symptomatic treatment
Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).
干预措施: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations) (Drug)
结局指标
主要结局
Number of participants who die due to COVID-19 infection
时间窗: 21 days post-randomization
Number of participants who require hospitalization due to COVID-19 infection
时间窗: 21 days post-randomization
次要结局
未报告次要终点