NCT04492358终止2 期
Phase 2/3, Randomized, Open Study to Compare the Efficacy and Safety of Colchicine and Glucocorticoids Compared With the Standard of Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center
Maria Joyera Rodríguez3 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年10月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Number of patients that a short cycle of steroids administered together with colchicine reduces mortality from COVID-19
研究概览
简要总结
Study to compare the efficacy and safety of colchicine and glucocorticoids compared with the standard of treatment for moderate/severe COVID-19 in a fragile and vulnerable population, admitted to a geriatric hospital unit or in a transicional care center
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 65 years old and be admitted to the Geriatrics Unit of the Internal Medicine Service (Hospital Clínic de Barcelona) or to a transicional care center
- •Clinical diagnosis compatible with COVID-19 (in a favourable epidemiological context), with a disease considered moderate (grade 3-4) or severe (grade 5) according to the WHO 8-point ordinal scale for assessing clinical severity (https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis). This same scale will also be used to evaluate the evolution after the application of the corresponding treatment. Baseline clinical parameters will include the presentation of fever and any respiratory symptoms, both of upper respiratory tract and dyspnea, affecting the general state or gastrointestinal manifestations, since it is known that in elderly people the COVID-19 can present with atypical symptoms for a time that is difficult to determine, but it also tends to evolve to respiratory failure quickly and is associated with high mortality. For this reason, regardless of the time that has elapsed since the estimated onset of symptoms, patients with moderate - WHO grade 3, in whom the presence of fever, mild dyspnea or any gastrointestinal manifestation attributable to COVID-19 make an admission (in the case of hospital) and directed treatment (in all cases) advisable, will be candidates for inclusion in the study. Patients with moderate disease and oxygen requirements (WHO grade 4) and patients with severe pneumonia, but who can be managed initially with high flow oxygen therapy (WHO grade 5) may also be included in the study. The clinical diagnosis may be supported by radiological changes (via chest radiography, if available) suggestive of bilateral (established or incipient) pneumonia. At the time of diagnosis, biomarkers will also be collected, in an analysis that will include increased levels of C-reactive protein [PCR] and/or ferritin and microbiological confirmation of SARS-CoV-
- •Patients in whom the current clinical situation and the basal functional situation condition a prognosis that makes them consider a limited therapeutic ceiling, which includes the contraindication of applying more aggressive (e.g. non-invasive ventilation) or invasive measures (e.g. cardiopulmonary resuscitation or orotracheal intubation and mechanical ventilation), both in patients admitted to the Geriatric Unit (Hospital Clínic de Barcelona) and in those admitted to a transicional care center. The latter patients are also not considered for transfer to a third level hospital (according to the criteria of fragility, available on page 14 of the CatSalut action protocols (https://canalsalut.gencat.cat/web/.content/_A-Z/C/coronavirus-2019-ncov/material-divulgatiu/recull-protocol-pneumonia.pdf).
- •Patient with a general condition that allows him/her to take the medication orally, without risk of bronchial aspiration.
- •Acceptance by the patient or responsible family member to participate in the study (written consent).
排除标准
- •The clinical situation of an advanced or terminal illness, according to the clinical judgment of the doctor in charge and as defined by the Spanish Society for Palliative Care (SECPAL), which describes it as an advanced illness in an evolutionary and irreversible phase with multiple symptoms, emotional impact, loss of autonomy, with very little or no capacity to respond to specific treatment and with a life expectancy limited to weeks or months, in a context of progressive fragility (http://envejecimiento.csic.es/documentos/documentos/navarro-cuidadospaliativos-01.pdf).
- •Clinical status which is advanced and severe or in which the level of consciousness has deteriorated and the oral route of taking the medication is not safely tolerated (in the opinion of the doctor in charge)
- •Taking any of the drugs in the trial (colchicine or prednisone) chronically or intermittently in the 7 days prior to study inclusion.
- •Absolute contraindication to the use of the study medication, including hypersensitivity to the active substance or to any of its excipients, severe renal failure (glomerular filtration [GF] creatinine clearance or Clcr <30 ml/min) and patients undergoing haemodialysis, severe liver failure, severe gastrointestinal disorders, gastric ulcer or blood dyscrasias.
- •Concomitant treatment with macrolides (clarithromycin, erythromycin, telithromycin), antifungals (itraconazole, ketoconazole), cyclosporine and antivirals (lopinavir/ritonavir, indinavir, nelfinavir, saquinavir), all potent inhibitors of CYP3A4 (key cytochrome in the colchicine metabolism pathway).
研究组 & 干预措施
colchicine + prednisone
Experimental
Prednisone should be administered for 3 consecutive days (60 mg/d) together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function) for 3 days and maintained for 14 days in total (0.5 mg/d).
干预措施: Colchicine (Drug)
colchicine + prednisone
Experimental
Prednisone should be administered for 3 consecutive days (60 mg/d) together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function) for 3 days and maintained for 14 days in total (0.5 mg/d).
干预措施: Prednisone tablet (Drug)
Standard treatment
Active Comparator
The standard treatment used in each site will be administered to the patients assigned to the control group.
干预措施: standard of care (Drug)
结局指标
主要结局
Number of patients that a short cycle of steroids administered together with colchicine reduces mortality from COVID-19
时间窗: 28 days
Number of patients that a short cycle of steroids (with prednisone 60 mg/d, in a single dose, for 3 consecutive days) administered together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function, for 3 days and maintenance of 0.5 mg/d for 14 days in total) reduces mortality from COVID-19 in this population by at least 20%, compared to the approved standard treatment at participating centers.
次要结局
- Number and grade of adverse events at group of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment(28 days)
- Severity of symptoms by COVID-19 in the two treatment arms(28 days)
- Percentage of patients who stop medication due to adverse events.(28 days)
研究者
Maria Joyera Rodríguez
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (3)
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