Dexamethasone sodium phosphate for Acute hypoxemic respiratory failure | Acute respiratory distress syndrome (ARDS)

Inclusion criteria

• {"criterion_text":"- Age ≥18 years."}
• {"criterion_text":"- Intubated and mechanically ventilated, defined as requiring ventilatory support at the time of Screening."}
• {"criterion_text":"- Acute onset of AHRF (as defined by a PaO2/FiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2/FiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.3. ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2."}
• {"criterion_text":"- Pulmonary or systemic infectious etiology of AHRF."}

Exclusion criteria

• {"criterion_text":"- Subjects with a known contraindication to corticosteroids or know hypersensitivity. History of any hypersensitivity reaction to dexamethasone, including but not limited to urticaria, eczema, angioedema, bronchospasm, and anaphylaxis."}
• {"criterion_text":"- Subjects who have an indication of chronic use of higher doses of systemic corticosteroids. Use of systemic corticosteroids in doses higher than 6 mg dexamethasone equivalents for other indications than COVID- 19: systemic corticosteroids in doses higher than 6 mg dexamethasone / 6 mg betamethasone / 200 mg cortisone / 160 mg hydrocortisone / 32 mg methylprednisolone / 40 mg prednisolone / 40 mg prednisone."}
• {"criterion_text":"- Subjects who have received corticosteroids for 5 consecutive days or more up to the day of screening."}
• {"criterion_text":"- Pregnant woman."}
• {"criterion_text":"- Participation in another therapeutic trial study that collide."}
• {"criterion_text":"- Lack of informed consent."}

Primary endpoints

• {"endpoint_text":"- All-cause hospital mortality.","definition_or_measurement_approach":"All-cause hospital mortality (death in hospital from any cause). Deaths will be recorded irrespective of whether the subject remains in the same hospital, in another health care facility, or discharged home; if subjects are discharged alive before day 60, clinical status information at 60 days will be obtained from the electronic clinical record."}

Secondary endpoints

• {"endpoint_text":"- Number of ventilator free-days (VFDs) at Day 28 (defined as days alive and free from mechanical ventilation at day 28 after intubation. For subjects ventilated >=28 days and for subjects who die, VFD is 0.","definition_or_measurement_approach":"Defined as days alive and free from mechanical ventilation at day 28 after intubation. For subjects ventilated ≥28 days and for subjects who die, VFD = 0. Successful liberation from MV should last >48 hours without reintubation; extubation counted from last successful attempt in survivors at day 28."}
• {"endpoint_text":"- Mortality at ICU and at Day 28.","definition_or_measurement_approach":"All-cause ICU mortality and all-cause mortality at Day 28."}
• {"endpoint_text":"- Duration (in days) on mechanical ventilation.","definition_or_measurement_approach":"Total days on mechanical ventilation during the observation period."}
• {"endpoint_text":"- Length of stay (in days) in the hospital for survivors.","definition_or_measurement_approach":"Number of days from hospital admission to discharge for survivors."}
• {"endpoint_text":"- Time (in days) from treatment initiation to death.","definition_or_measurement_approach":"Days from first treatment dose to date of death."}
• {"endpoint_text":"- Proportions with viral RNA detection over time.","definition_or_measurement_approach":"Proportion of subjects with detectable viral RNA at scheduled time points over the study period."}

Spain

Earliest CTIS Part Ii Submission Date

19-11-2024

Latest Decision Or Authorization Date

20-12-2024

Processing Time Days

31

Number Of Sites

11

Number Of Participants

980

Primary sponsor

Full Name

Consorcio Centro De Investigacion Biomedica En Red

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain