Efficacy of captopril nebulization in Covid-19 patients suffering of SARS-CoV-2 pneumonia.A randomized phase II study - CAPTOCOVID

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 230 人开始时间: 2020年4月11日最近更新: 2020年5月11日

适应症

试验速览

暂无简介。

•1- Hospitalization for acute respiratory failure requiring oxygen administration =3L/mn
•2- Age > 18 years or older
•3- Presence of pneumonia
•4- PCR SARS-CoV-2 positive in any biological sample in the last 7 days
•5- Patient affiliated to social security regime
•6- Written informed consent provided by the patient or alternatively by next-of-kin, or in emergency situations, prior to any protocol-specific procedures
•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 115
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 115

•1- Decision of withholding invasive mechanical ventilation
•2- Shock requiring vasopressor infusion
•3- Co-infection with another respiratory pathogen which could be responsible of pneumonia
•4- Hypersensitivity to captopril, to any other angiotensin converting enzyme inhibitor or any of the excipients of the specialty used
•5- History of angio-oedema
•6- History of ACE-inhibitor allergy
•7- Known pregnancy or current lactation: Female subject of childbearing potential should have a negative serum
•pregnancy test prior to receiving the first dose of study medication.
•8- Patient who is currently enrolled in other investigational study;
•9- Persons deprived of their liberty by judicial or administrative decision,
•10- Persons under legal protection/safeguard of justice,
•11- Patients under duress psychiatric care,
•12- Persons admitted to a health or social institution
•13- Patient on AME (state medical aid)

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