Efficacy of captopril in Covid-19 patients suffering of pneumonia
- Conditions
- Patient =18 with SARS Cov 2 pneumonia requiring oxygen administration.MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001700-42-FR
- Lead Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 230
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy of captopril nebulization addition to standard of care compared to standard of care in term of 14-day ventilation free survival;Secondary Objective: To demonstrate the efficacy and safety of captopril nebulization:<br>- Efficacy :<br>• Mortality at 28 day<br>• Need of invasive mechanical ventilation (IMV) at 28 days<br>• Length of hospitalization<br>• Length of stay in ICU<br>• Length of mechanical ventilation<br>- Safety :<br>• Respiratory tolerance<br>• Hemodynamic tolerance<br>• Metabolic tolerance<br>• Renal tolerance<br>• Skin tolerance;Primary end point(s): 14-day invasive mechanical ventilation free survival: defined as the proportion of patients requiring IMV or dying between randomization and Day 14;Timepoint(s) of evaluation of this end point: 14 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Efficacy :<br>• Overall 28-day mortality<br>• Number of days alive without IMV at 28 days<br>• Length of stay in ICU in days (restricted to 28 days)<br>• Length of hospitalization (restricted to 28 days).<br>• Length of mechanical ventilation (restricted to 28 days).<br>- Safety :<br>• Respiratory tolerance:<br>- Unstoppable cough requiring nebulization interruption<br>- Increasing of O2 flow more than 3L/mn<br>• Hemodynamic tolerance:<br>- Hypotension requiring nebulization interruption<br>- Hypotension requiring vasopressor infusion in the 24h after nebulization<br>• Metabolic tolerance:<br>Hyperkaliemia requiring calcium gluconate administration or renal replacement therapy (RRT) in the 72h after nebulization<br>• Renal tolerance:<br>Creatinine level increasing of more 50% or renal replacement therapy in the 72h after nebulization<br>• Skin tolerance:<br>Angiooedemea in the 72h after nebulization;Timepoint(s) of evaluation of this end point: 28 days