Interest in the administration of Dornase alpha aerosol in Acute Respiratory Distress Syndrome secondary to respiratory infection by the coronavirus SRASCoV-2 / COVID-19

Interest in the administration of Dornase alpha aerosol in ARDS secondary to respiratory infection by the coronavirus SRASCoV-2 / COVID-19 - COVID19-COVIDornase

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001492-33-FR

Enrollment

100

Registered

2020-04-01

Start date

2020-04-10

Completion date

Unknown

Last updated

2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients on mechanical ventilation, inpatient resuscitation for ARDS, secondary to COVID-19 infection

Interventions

Trade Name: Pulmozyme 2500 U/2,5ml, solution pour inhalation par nébuliseur Pharmaceutical Form: Inhalation solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Major patient (age = 18 years old); - Hospitalized in intensive care; - Severe pneumonia COVID-19 with Berlin criteria for ARDS (PaO2/FiO25). - 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

Exclusion criteria: - Known hypersensitivity to Dornase alfa or any of the excipients; - Pregnant or nursing woman; - Patient with legal pro

Design outcomes

Primary

Measure	Time frame
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 2) the clinical evolution at D28 ; 3) the duration of mechanical ventilation; 4) the number of days without mechanical ventilation at D28; 5) the length of stay in intensive care ; 6) the concentrations of blood markers of inflammation over time; 7) NET concentrations in bronchial secretions over time 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	—

Measure

Time frame

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 2) the clinical evolution at D28 ; 3) the duration of mechanical ventilation; 4) the number of days without mechanical ventilation at D28; 5) the length of stay in intensive care ; 6) the concentrations of blood markers of inflammation over time; 7) NET concentrations in bronchial secretions over time 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

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: 1) all-cause mortality at D28 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; 3) Duration of mechanical ventilation (days); 4) Number of days without mechanical ventilation at D28 5) Length of stay in intensive care (days) ; 6) Concentrations of blood markers of inflammation (D0, D2, D7 and discharge); 7) NET concentrations in bronchial secretions (D0, D2, D7 and discharge); 8) Rates of adverse events and serious adverse events.;Timepoint(s) of evaluation of this end point: D28	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: 1) all-cause mortality at D28 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; 3) Duration of mechanical ventilation (days); 4) Number of days without mechanical ventilation at D28 5) Length of stay in intensive care (days) ; 6) Concentrations of blood markers of inflammation (D0, D2, D7 and discharge); 7) NET concentrations in bronchial secretions (D0, D2, D7 and discharge); 8) Rates of adverse events and serious adverse events.;Timepoint(s) of evaluation of this end point: D28

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Countries

France

Contacts

Public ContactClinical Research Director

Hôpital Fondation Adolphe de Rothschild

pvachey@for.paris33148036433

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026