Patient =18 with SARS Cov 2 pneumonia requiring oxygen administration. MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: CAPTOPRIL
Pharmaceutical Form: Concentrate for nebuliser solution
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - Efficacy : • Mortality at 28 day • Need of invasive mechanical ventilation (IMV) at 28 days • Length of hospitalization • Length of stay in ICU • Length of mechanical ventilation - Safety : • Respiratory tolerance • Hemodynamic tolerance • Metabolic tolerance • Renal tolerance • 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Efficacy : • Overall 28-day mortality • Number of days alive without IMV at 28 days • Length of stay in ICU in days (restricted to 28 days) • Length of hospitalization (restricted to 28 days). • Length of mechanical ventilation (restricted to 28 days). - Safety : • Respiratory tolerance: - Unstoppable cough requiring nebulization interruption - Increasing of O2 flow more than 3L/mn • Hemodynamic tolerance: - Hypotension requiring nebulization interruption - Hypotension requiring vasopressor infusion in the 24h after nebulization • Metabolic tolerance: Hyperkaliemia requiring calcium gluconate administration or renal replacement therapy (RRT) in the 72h after nebulization • Renal tolerance: Creatinine level increasing of more 50% or renal replacement therapy in the 72h after nebulization • Skin tolerance: Angiooedemea in the 72h after nebulization;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Outcome results
None listed