NCT04977960Unknown2 期
MINECRAFT Study: MINEralcorticoid Receptor Antagonism With CanRenone As eFfective Treatment in Moderate to Severe ARDS in COVID-19, a Phase 2 Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 180
- 主要终点
- in-hospital death
研究概览
简要总结
The main aim of the study is to estimate the potential efficacy of i.v. canrenone as add-on therapy on maximal medical treatment versus maximal medical treatment alone in treating moderate-to-severe ARDS due to SARS-CoV-2.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80 y.o. Since over eighties are very fragile patients, a lot of confounding unpredictable events may interfere with the trial analyses; thus, these patients will be excluded from this exploratory proof-of-concept trial;
- •COVID-19 diagnosis through swab within 14 days from the beginning of symptoms
- •Hospitalization for moderate to severe ARDS (as determined by PaO2/FiO2 ≤300 mmHg at admission)
- •Serum concentration of potassium ≤4.5 mEq/L
- •Consent to participate
排除标准
- •Invasive mechanical ventilation
- •I.v. hydratation with Darrow's solution or half-strength Darrow's solution underway
- •Acute cardiovascular event (acute myocardial infarction, acute ischaemic stroke)
- •Current malignant disease
- •Creatinine >1.8 mg/dL (for women) and >2.0 mg/dL (for men) or glomerular filtration rate <50 mL/mm
- •Systolic blood pressure <110 mmHg and/or diastolic blood pressure <60 mmHg
- •Known or suspected hypersensitivity to canrenone
- •Hyponatremia
- •Familial history of porphyria
- •Pregnancy and breastfeeding
- •known or suspected hypersensitivity to canrenone
- •Inclusion in any other pharmacological clinical trials
研究组 & 干预措施
Experimental Group
Experimental
Patients randomized in the Experimental Group will receive canrenone as add-on therapy to standard-of-care treatments. Different starting doses of i.v. canrenone will be administrated in a single or double infusion per day, for 7 days, according to the serum concentration of potassium at randomization
干预措施: Potassium Canrenoate (Drug)
结局指标
主要结局
in-hospital death
时间窗: At the event (discharge or death)
patients discharged to a long-term care facility will be classified as "discharged alive"
次要结局
- Need of invasive mechanical ventilation throughout hospitalization(at discharge or death)
- Number of hyperkaliemias events(From the date of randomization until three days after the end of IMP administration (10 days after randomization))
- Change in respiratory parameters(at 48 hours and 168 hours (7th day) from randomization)
- Change in inflammatory status(at 48 hours and 168 hours (7th day) from randomization)
- Number of renal failures(From the date of randomization until three days after the end of IMP administration (10 days after randomization))
- Changes in [K+]hematic, renin, AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids(at randomization and at 48 and 168 hours (7th day) from randomization)
- Correlation between levels of [K+]hematic, renin, AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids, at basal level (randomization) and clinical outcomes (in-hospital death, need of invasive mechanical ventilation, SOFA score)(at randomization and at 48 and 168 hours (7th day) from randomization)
- Duration of hospitalization for alive patients(From date of randomization until the date discharge or in-hospital death from any cause, whichever came first, assessed up to 48 months)
- Number of hypotensive events(From the date of randomization until three days after the end of IMP administration (10 days after randomization))
- Changes in features of pulmonary interstitial disease measured by chest X-Ray(at 7 days after randomization)
- Drug intolerance(From the date of randomization until three days after the end of IMP administration (10 days after randomization))
- Change in Sequential Organ Failure Assessment (SOFA) score from randomization to 7 days after randomization(7 days after randomization)
研究者
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