Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002632-75 | EudraCT Number |
Not provided
Not provided
Not provided
The enrolment was extended. Nevertheless, despite the Sponsor's attempts, the infection status did not permit the identification of eligible patients for the study to complete it in a reasonable time.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients diagnosed with SARS-COV-19 acute respiratory distress syndrome (ARDS).
This was a multicentre, open-label, randomized phase II proof-of-concept study.
The efficacy and safety of poractant alfa was evaluated in terms of ventilatory free days during the 21 days after randomization, in adult patients diagnosed with ARDS due to SARS-COV-19 infection.
Each patient randomized to the study treatment received 3 administrations of Curosurf ® with a 24 hours dosing interval. The assessment collection was up to Day 28, when the evaluation occurred at the Intensive Care Unit (ICU), or by phone call if the patient has already been discharged.
Seventy patients were planned to be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm). The control arm population received Standard of Care (SoC). This study was conducted in United Kingdom (UK), United States of America (US), and Italy.
Overall, 13 patients (Curosurf ® group) and 8 patients (control group) were randomised in the study. Due to low recruitment rate the study was terminated early for non-safety reasons.
Curosurf® is a pulmonary surfactant of natural origin which, when delivered endotracheally (ET). Curosurf® is currently approved for marketing as treatment of premature neonates with RDS or at risk of Respiratory Distress Syndrome (RDS). Chiesi Farmaceutici S.p.A (Chiesi) conducted this study with its porcine-derived surfactant, Curosurf® (poractant alfa), to evaluate the efficacy and safety in ventilated adult patients who were critically unwell in intensive care with SARS-COV-19 ARDS.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients treated with standard-of-care (SoC), as control cohort | |
| Poractant alfa | Experimental | Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CUROSURF® (poractant alfa) | Drug | Three administrations with a 24 hours dosing interval. Each endotracheal (ET) administration 1, 2, and 3 consisted of poractant alfa bolus: 30mg /kg (Lean Body Weight-LBW) = 0.375ml /kg LBW, diluted with normal saline up to 2ml /kg LBW. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Alive and Ventilator-free Days | The number of days alive and ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation over the 21 days following randomisation. Mechanical ventilation was defined as invasive and non-invasive. The patient was defined as free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who died or were mechanically ventilated longer than this period were assessed as zero ventilator-free days. | up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Alive and Free of Respiratory Failure at Day 28 | The percentage of patients alive and free of respiratory failure (i.e. without need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation, or high-flow nasal cannula oxygen delivery) at Day 28. | at Day 28 |
Not provided
Inclusion Criteria:
Participants were eligible to be included in the study if the following criteria apply:
Exclusion Criteria:
Participants were excluded from the study if any of the following criteria apply:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clark Howard, Prof. /MD | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States | ||
| Chiesi site # 14 |
Not provided
| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The planned 70 randomised patients in a 3:2 ratio, according to the inclusion and exclusion criteria. This was not achieved; owing to a global improvement in the pandemic situation in the countries where the study was performed (Italy, UK, US), patient recruitment was lower than expected (i.e. 22 patients were randomised, 14 patients and 8 patients in the poractant alfa and control groups, respectively); the study was terminated early before reaching the target sample size.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Cohort | Patients receiving standard-of-care (SoC) |
| FG001 | Poractant Alfa Treated Cohort | Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2021 | Mar 16, 2023 |
Not provided
Not provided
Seventy patients will be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm).
Not provided
Not provided
Not provided
Not provided
| Number of Days Alive and Ventilator-Free at Day 28 |
The number of days alive and ventilator-free (i.e. free of any mechanical ventilation for at least 12 hours) at Day 28. |
| at Day 28 |
| Mortality at Day 21 and Day 28 | Mortality at Day 21 and Day 28 of the study by treatment group. | at Day 21 and at Day 28 |
| Number of Days Alive and Free From Invasive Ventilation at Day 21 and Day 28 | The number of days alive and free from invasive ventilation at Day 21 and Day 28 is presented by treatment group. | Day 21 and Day 28 |
| Number of Days Alive and Free From Non-Invasive Ventilation at Day 21 and Day 28 | The number of days alive and free from non-invasive ventilation at Day 21 and Day 28 is presented by treatment group. | Day 21 and Day 28 |
| Percentage of Patients With Improvement in Severity Status at Day 28 or Discharge (Severity Score: Mild, Moderate, Severe, or Death) | The severity status of patients at baseline and at Day 28/Discharge and the percentage of patients with improvement in severity status (i.e. a decrease of at least 1 point in severity status) at Day 28/Discharge relative to baseline is presented. Severity was assessed using a point score system: Severity score was defined as mild, moderate, severe (see below*), or death and was based on PaO2/FiO2 ratio and patient status at Day 28/Discharge and numerically rated from 1-4, respectively. An improvement in severity was defined as a decrease of at least 1 point between baseline and Day 28/Discharge. At Day 28 the last follow up evaluation took place on the ICU if, still requiring critical care, or by phone call if the patient has been discharged from ICU by that time. *Mild: 200 mmHg < PaO2/FiO2 ratio ≤300 mmHg; Moderate: 100 mmHg < PaO2/FiO2 ratio ≤200 mmHg; Severe: PaO2/FiO2 ratio ≤100 mmHg | Day 28 or Discharge, whichever comes first |
| Change From Baseline in Arterial Partial Pressure of Oxygen / Fraction of Inspired Oxygen (PaO2/FiO2) Ratio at Each Timepoint | Change from baseline in PaO2/FiO2 ratio measured at each timepoint following administration of each dose in the treatment and control group. The change was calculated from two time points as the value at the later time point minus the value at baseline. Partial pressure of oxygen (PaO2) is the oxygen pressure in arterial blood. The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture. The fraction of inspired oxygen (PaO2/FiO2) ratio is widely used in ICUs as an indicator of oxygenation status. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
| Percentage of Patients Alive and With PaO2/FiO2 Ratio Improvement >20% Compared to Baseline at Each Timepoint | The percentages of patients in categories of PaO2/FiO2 ratio improvement compared to baseline (>20%) at all timepoints post-baseline are summarised by treatment group. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| Change From Baseline in Fraction of Inspired Oxygen (FiO2) at Each Timepoint | The FiO2 at baseline and at selected timepoints post-baseline was measured. Results are shown as changes from baseline, summarised by treatment group. The change was calculated from two time points as the value at the later time point minus the value at baseline. The unit for the variable is percent (%) and what is reported is an absolute change. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| Length of ICU Stay (Days) at Day 28 | The length of ICU stay (days) at Day 28 is presented by treatment by treatment group. Patients who died or were mechanically ventilated longer than this period were assigned with 28 days. | up to 28 days |
| Percentage of Patients Alive and Out of Intensive Care Unit (ICU) at Day 28 | The percentage of patients alive and out of ICU at Day 28 is presented by treatment group. | Day 28 |
| Delta Sequential Organ Failure Assessment (SOFA) Score and Sub-component Measure at Day 3 and Day 28 | The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body. The SOFA score was used to determine the extent of organ failure at Day 3 and Day 28/Discharge with respect to a pre-randomisation assessment. The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output. A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0. | Day 3 and Day 28 or discharge -- whichever comes first |
| Percentage of Patients Alive and Free of Organ Failure (SOFA Score=0) | The percentage of patients alive and organ failure free (defined as SOFA score=0) at Day 28/Discharge is presented by treatment group. The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output. A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0. | at day 28 or discharge -- whichever comes first |
| Ventilatory Parameter: Tidal Volume -- Change From Baseline in Tidal Volume (mL/kg BW) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Change from baseline in tidal volume (mL/kg BW) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| Ventilatory Parameter: Respiratory Rate -- Change From Baseline in Respiratory Rate (Breaths/Minute) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Change from baseline in respiratory rate (breaths/minute) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. Respiratory rate is the number of breaths taken per minute. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| Ventilatory Parameter: Dynamic Compliance -- Change From Baseline in Dynamic Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Change from baseline in dynamic compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. Dynamic compliance: is the continuous measurement of pulmonary compliance calculated at each point representing schematic changes during rhythmic breathing. Dynamic compliance monitors both elastic and airway resistance. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| Ventilatory Parameter: Static Compliance -- Change From Baseline in Static Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: static compliance -- change from baseline in static compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Static Compliance: represents pulmonary compliance at a given fixed volume when there is no airflow, and muscles are relaxed. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| Ventilatory Parameter: Positive End-Expiratory Pressure (PEEP) -- Change From Baseline in PEEP (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Positive End-Expiratory Pressure -- Change from baseline in PEEP (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Positive end-expiratory pressure (PEEP) is the positive pressure that will remain in the airways at the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated patients. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| Ventilatory Parameter: Peak Inspiratory Pressure -- Change From Baseline in Peak Inspiratory Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Peak Inspiratory Pressure -- Change from baseline in peak inspiratory pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Peak inspiratory pressure (PIP) is the highest level of pressure applied to the lungs during inhalation. In mechanical ventilation the number reflects a positive pressure in centimetres of water pressure (cmH2O). | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| Ventilatory Parameter: Plateau Pressure -- Change From Baseline in Plateau Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Plateau Pressure -- Change from baseline in plateau pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Plateau pressure is the pressure that is applied by the mechanical ventilator to the small airways and alveoli. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
| Blood Gas Analysis Acid-base Balance Parameters: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameters -- pH | Change from baseline in blood gas analysis acid-base balance parameters -- pH. The change was calculated from two time points as the value at the later time point minus the value at baseline. Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
| Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Carbon Dioxide (pCO2) | Change from baseline in blood gas analysis acid-base balance parameter -- pCO2. The change was calculated from two time points as the value at the later time point minus the value at baseline. Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
| Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Oxygen (pO2) | Change from baseline in blood gas analysis acid-base balance parameter -- pO2. The change was calculated from two time points as the value at the later time point minus the value at baseline. Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
| Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Bicarbonate (HCO3) | Change from baseline in blood gas analysis acid-base balance parameter -- Bicarbonate (HCO3). The change was calculated from two time points as the value at the later time point minus the value at baseline. Measured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours till the patient is discharged from the ICU | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
| Change From Baseline in Blood Parameter -- Lactate | Change from baseline in blood parameter -- Lactate The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Arterial blood lactate was measured at 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier. | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
| Mortality -- TEAEs Leading to Death | The incidence of treatment-emergent adverse event (TEAEs) leading to death is presented by treatment group. | up to day 28 |
| Bologna |
| 40138 |
| Italy |
| Chiesi site #13 | Modena | 41124 | Italy |
| UCLH and UCL 250 Euston Road | London | NW1 2BU | United Kingdom |
| Chiesi site #4 | London | SW10 9NH | United Kingdom |
| Chiesi site # 12 | Southampton | SO16 6YD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-Treat (ITT) population used for this parameter.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Cohort | Patients receiving SoC |
| BG001 | Poractant Alfa Treated Cohort | Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Arterial Partial Pressure of Oxygen/Fraction of inspired oxygen (PaO2/FiO2) ratio | The ratio of partial pressure of oxygen in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2) is an indicator of pulmonary shunt fraction. PaO2/FiO2 (P/F) ratio is used to classify severity of acute respiratory distress syndrome (ARDS). To calculate the P/F Ratio: PaO2 / FIO2. "P" represents PaO2 (arterial pO2) from the arterial blood gas. "F" represents the FIO2 - the fraction (percent) of inspired oxygen that the patient is receiving expressed as a decimal (40% oxygen = FIO2 of 0.40). P divided by F = P/F ratio | Mean | Standard Deviation | Ratio |
| ||||||||||||||||
| Fraction of inspired oxygen (FiO2) | The fraction of inspired oxygen, FiO2, is an estimation of the oxygen content a person inhales and is thus involved in gas exchange at the alveolar level. | Mean | Standard Deviation | percentage of inspired oxygen |
| ||||||||||||||||
| Sequential Organ Failure Assessment (SOFA) score | Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. Total score ranged from 0 to 24 points; to be considered organ failure free, a patient had to have a score of 0. | Mean | Standard Deviation | score |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days Alive and Ventilator-free Days | The number of days alive and ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation over the 21 days following randomisation. Mechanical ventilation was defined as invasive and non-invasive. The patient was defined as free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who died or were mechanically ventilated longer than this period were assessed as zero ventilator-free days. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Mean | Standard Deviation | days | up to 21 days |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Alive and Free of Respiratory Failure at Day 28 | The percentage of patients alive and free of respiratory failure (i.e. without need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation, or high-flow nasal cannula oxygen delivery) at Day 28. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Number | percentage of participants | at Day 28 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Days Alive and Ventilator-Free at Day 28 | The number of days alive and ventilator-free (i.e. free of any mechanical ventilation for at least 12 hours) at Day 28. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Mean | Standard Deviation | days | at Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Mortality at Day 21 and Day 28 | Mortality at Day 21 and Day 28 of the study by treatment group. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Count of Participants | Participants | at Day 21 and at Day 28 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Days Alive and Free From Invasive Ventilation at Day 21 and Day 28 | The number of days alive and free from invasive ventilation at Day 21 and Day 28 is presented by treatment group. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | days | Day 21 and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Days Alive and Free From Non-Invasive Ventilation at Day 21 and Day 28 | The number of days alive and free from non-invasive ventilation at Day 21 and Day 28 is presented by treatment group. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | days | Day 21 and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Improvement in Severity Status at Day 28 or Discharge (Severity Score: Mild, Moderate, Severe, or Death) | The severity status of patients at baseline and at Day 28/Discharge and the percentage of patients with improvement in severity status (i.e. a decrease of at least 1 point in severity status) at Day 28/Discharge relative to baseline is presented. Severity was assessed using a point score system: Severity score was defined as mild, moderate, severe (see below*), or death and was based on PaO2/FiO2 ratio and patient status at Day 28/Discharge and numerically rated from 1-4, respectively. An improvement in severity was defined as a decrease of at least 1 point between baseline and Day 28/Discharge. At Day 28 the last follow up evaluation took place on the ICU if, still requiring critical care, or by phone call if the patient has been discharged from ICU by that time. *Mild: 200 mmHg < PaO2/FiO2 ratio ≤300 mmHg; Moderate: 100 mmHg < PaO2/FiO2 ratio ≤200 mmHg; Severe: PaO2/FiO2 ratio ≤100 mmHg | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Number | percentage of participants | Day 28 or Discharge, whichever comes first |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Arterial Partial Pressure of Oxygen / Fraction of Inspired Oxygen (PaO2/FiO2) Ratio at Each Timepoint | Change from baseline in PaO2/FiO2 ratio measured at each timepoint following administration of each dose in the treatment and control group. The change was calculated from two time points as the value at the later time point minus the value at baseline. Partial pressure of oxygen (PaO2) is the oxygen pressure in arterial blood. The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture. The fraction of inspired oxygen (PaO2/FiO2) ratio is widely used in ICUs as an indicator of oxygenation status. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. At each time point the number of patients that contributed with a result value is indicated for both study arms. | Posted | Median | Full Range | mmHg | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Alive and With PaO2/FiO2 Ratio Improvement >20% Compared to Baseline at Each Timepoint | The percentages of patients in categories of PaO2/FiO2 ratio improvement compared to baseline (>20%) at all timepoints post-baseline are summarised by treatment group. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Number | percentage of participants | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fraction of Inspired Oxygen (FiO2) at Each Timepoint | The FiO2 at baseline and at selected timepoints post-baseline was measured. Results are shown as changes from baseline, summarised by treatment group. The change was calculated from two time points as the value at the later time point minus the value at baseline. The unit for the variable is percent (%) and what is reported is an absolute change. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | percent (absolute change) | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Length of ICU Stay (Days) at Day 28 | The length of ICU stay (days) at Day 28 is presented by treatment by treatment group. Patients who died or were mechanically ventilated longer than this period were assigned with 28 days. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | days | up to 28 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Alive and Out of Intensive Care Unit (ICU) at Day 28 | The percentage of patients alive and out of ICU at Day 28 is presented by treatment group. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Number | percentage of participants | Day 28 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Delta Sequential Organ Failure Assessment (SOFA) Score and Sub-component Measure at Day 3 and Day 28 | The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body. The SOFA score was used to determine the extent of organ failure at Day 3 and Day 28/Discharge with respect to a pre-randomisation assessment. The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output. A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | score on a scale | Day 3 and Day 28 or discharge -- whichever comes first |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Alive and Free of Organ Failure (SOFA Score=0) | The percentage of patients alive and organ failure free (defined as SOFA score=0) at Day 28/Discharge is presented by treatment group. The total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output. A score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Number | percentage of participants | at day 28 or discharge -- whichever comes first |
| |||||||||||||||||||||||||||||||
| Secondary | Ventilatory Parameter: Tidal Volume -- Change From Baseline in Tidal Volume (mL/kg BW) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Change from baseline in tidal volume (mL/kg BW) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | mL/kg BW | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Ventilatory Parameter: Respiratory Rate -- Change From Baseline in Respiratory Rate (Breaths/Minute) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Change from baseline in respiratory rate (breaths/minute) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. Respiratory rate is the number of breaths taken per minute. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | breaths/minute | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Ventilatory Parameter: Dynamic Compliance -- Change From Baseline in Dynamic Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Change from baseline in dynamic compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. Dynamic compliance: is the continuous measurement of pulmonary compliance calculated at each point representing schematic changes during rhythmic breathing. Dynamic compliance monitors both elastic and airway resistance. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. At each time point the number of patients that contributed with a result value is indicated for both study arms. | Posted | Median | Full Range | mL/cmH2O | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| ||||||||||||||||||||||||||||||
| Secondary | Ventilatory Parameter: Static Compliance -- Change From Baseline in Static Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: static compliance -- change from baseline in static compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Static Compliance: represents pulmonary compliance at a given fixed volume when there is no airflow, and muscles are relaxed. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | mL/cmH2O | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| ||||||||||||||||||||||||||||||
| Secondary | Ventilatory Parameter: Positive End-Expiratory Pressure (PEEP) -- Change From Baseline in PEEP (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Positive End-Expiratory Pressure -- Change from baseline in PEEP (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Positive end-expiratory pressure (PEEP) is the positive pressure that will remain in the airways at the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated patients. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | cmH2O | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| ||||||||||||||||||||||||||||||
| Secondary | Ventilatory Parameter: Peak Inspiratory Pressure -- Change From Baseline in Peak Inspiratory Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Peak Inspiratory Pressure -- Change from baseline in peak inspiratory pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Peak inspiratory pressure (PIP) is the highest level of pressure applied to the lungs during inhalation. In mechanical ventilation the number reflects a positive pressure in centimetres of water pressure (cmH2O). | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | cmH2O | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28 |
| ||||||||||||||||||||||||||||||
| Secondary | Ventilatory Parameter: Plateau Pressure -- Change From Baseline in Plateau Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28 | Ventilatory parameter: Plateau Pressure -- Change from baseline in plateau pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28. The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Plateau pressure is the pressure that is applied by the mechanical ventilator to the small airways and alveoli. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | cmH2O | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
| ||||||||||||||||||||||||||||||
| Secondary | Blood Gas Analysis Acid-base Balance Parameters: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameters -- pH | Change from baseline in blood gas analysis acid-base balance parameters -- pH. The change was calculated from two time points as the value at the later time point minus the value at baseline. Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | pH | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Carbon Dioxide (pCO2) | Change from baseline in blood gas analysis acid-base balance parameter -- pCO2. The change was calculated from two time points as the value at the later time point minus the value at baseline. Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | mmHg | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Oxygen (pO2) | Change from baseline in blood gas analysis acid-base balance parameter -- pO2. The change was calculated from two time points as the value at the later time point minus the value at baseline. Arterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | mmHg | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Bicarbonate (HCO3) | Change from baseline in blood gas analysis acid-base balance parameter -- Bicarbonate (HCO3). The change was calculated from two time points as the value at the later time point minus the value at baseline. Measured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours till the patient is discharged from the ICU | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | mmol/L | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Blood Parameter -- Lactate | Change from baseline in blood parameter -- Lactate The change was calculated from two time points as the value at the later time point minus the value at baseline. At each time point the number of patients that contributed with a result value is indicated for both study arms. Arterial blood lactate was measured at 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier. | Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline. Data was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons. | Posted | Median | Full Range | mmol/L | up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Mortality -- TEAEs Leading to Death | The incidence of treatment-emergent adverse event (TEAEs) leading to death is presented by treatment group. | Safety Population: all randomised patients (who received at least one dose of the study treatment if poractant alfa-treated). | Posted | Count of Participants | Participants | up to day 28 |
|
|
From screening procedures (Day 0) to the end of the study (Day 28).
Analysis of adverse events (AEs) was performed on TEAEs, defined as AEs that started at or after treatment start (for the poractant alfa group) or at or after randomisation (for the control group).
Safety set (SAF) was used to evaluate AEs and serious AEs (SAEs). The SAF included all enrolled patients, except for one, who was randomised to receive poractant alfa was not treated. All patients included in the SAF were also included in the ITT.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Cohort | Patients receiving standard-of-care (SoC) | 2 | 8 | 3 | 8 | 5 | 8 |
| EG001 | Poractant Alfa Treated Cohort | Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC) | 4 | 13 | 5 | 13 | 11 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebral disorder | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumococcal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Proteus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Refractoriness to platelet transfusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
Once the impact of the Covid 19 pandemic significantly declined and intubated patients with acute respiratory distress syndrome (ARDS) outcome became rare, the Sponsor considered it unfeasible to maintain efforts to recruit further patients into the study. Thus, due to low recruitment, the study was terminated early for non-safety reasons.
Chiesi can publish and/or present any results of this study at scientific meetings, and to submit the clinical trial data to national and international Regulatory Authorities. Chiesi reserves the right to use such data for industrial purposes. Investigators will inform Chiesi before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation. Data from individual study sites must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Transparency | Chiesi Farmaceutici S.p.A. | + 39 0521 2791 | clinicaltrials_info@chiesi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2022 | Mar 16, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C068291 | poractant alfa |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC) |
|
|
|
|
|
|
|
|
|
Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)
|
|
|
|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|