Interest in the administration of Dornase alpha aerosol in Acute Respiratory Distress Syndrome secondary to respiratory infection by the coronavirus SRASCoV-2 / COVID-19
Phase 1
- Conditions
- Patients on mechanical ventilation, inpatient resuscitation for ARDS, secondary to COVID-19 infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001492-33-FR
- Lead Sponsor
- Hôpital Fondation Adolphe de Rothschild
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Major patient (age = 18 years old);
- Hospitalized in intensive care;
- Severe pneumonia COVID-19 with Berlin criteria for ARDS (PaO2/FiO2<300 and PEP>5).
- Intubated for less than 8 days ;
- Expected duration of mechanical ventilation is >48 hours;
- Carrying an arterial catheter;
- Affiliated with or beneficiary of a health insurance social protection scheme
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
- Known hypersensitivity to Dornase alfa or any of the excipients;
- Pregnant or nursing woman;
- Patient with legal pro
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of intratracheal administration of dornase alfa (Pulmozyme) on the evolution of ventilatory parameters at D7;Secondary Objective: 1) all-cause mortality at D28<br>2) the clinical evolution at D28 ;<br>3) the duration of mechanical ventilation;<br>4) the number of days without mechanical ventilation at D28;<br>5) the length of stay in intensive care ;<br>6) the concentrations of blood markers of inflammation over time;<br>7) NET concentrations in bronchial secretions over time<br>8) the occurrence of adverse events;Primary end point(s): Comparison between the two treatment arms of the evolution of the PaO2/FiO2 ratio between D0 (inclusion) and D7;Timepoint(s) of evaluation of this end point: D7
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoints:<br>1) all-cause mortality at D28<br>2) Delay until improvement of at least 2 points on a 7-point ordinal scale (based on Cao et al. 2020), or until hospital discharge;<br>3) Duration of mechanical ventilation (days);<br>4) Number of days without mechanical ventilation at D28<br>5) Length of stay in intensive care (days) ;<br>6) Concentrations of blood markers of inflammation (D0, D2, D7 and discharge);<br>7) NET concentrations in bronchial secretions (D0, D2, D7 and discharge);<br>8) Rates of adverse events and serious adverse events.;Timepoint(s) of evaluation of this end point: D28