MINECRAFT Study: MINEralcorticoid receptor antagonism with CanRenone As eFfective Treatment in moderate to severe ARDS in COVID-19, a phase 2 clinical trial. - Canrenone for COVID-19 patients

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO0 个研究点目标入组 180 人开始时间: 2021年8月17日最近更新: 2021年8月24日

适应症

试验速览

暂无简介。

•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•- Invasive mechanical ventilation
•- I.v. hydratation with Darrow’s solution or half-strenght 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
•- Hyponatremia
•- Familial history of porphyria
•- Pregnancy or breastfeeding
•- known or suspected hypersensitivity to canrenone
•- Inclusion in any other pharmacological clinical trials

发起方