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CUROSURF® (poractant alfa)Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug320 Azithromycin Tablets Wiki 0.71
drug1301 Hydroxychloroquine Sulfate Wiki 0.28

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D013577 Syndrome NIH 0.10
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.09
D012128 Respiratory Distress Syndrome, Adult NIH 0.08

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Multicenter, Open-label, Randomised Trial to Assess the Efficacy and Tolerability of Poractant Alfa(Porcine Surfactant, Curosurf®) in Hospitalized Patients With SARS-COV-19 Acute Respiratory Distress Syndrome (ARDS)

The purpose of this Phase II -Proof of Concept study is to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in adult hospitalized patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)

NCT04502433 Acute Respiratory Distress Syndrome Drug: CUROSURF® (poractant alfa)
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: The primary outcome variable will be the number of ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation during the 21 days following randomisation.

Measure: number of ventilator-free days

Time: up to 21 days

Secondary Outcomes

Measure: Number of free days from invasive ventilation

Time: up to 21 days

Measure: Number of free days from non-invasive ventilation (NIV)

Time: up to 21 days

Measure: Change from baseline in PaO2/FiO2 ratio measured at 6 hours and 12 hours following administration of each dose in the treated group and at the similar timepoints in the control group

Time: 6, 12, 30, 36, 54 and 60 hours after randomisation

Measure: Change from baseline in PaO2/FiO2 ratio at additional timepoints

Time: every 24 hours after treatment/randomisation until the patient is discharged from the ICU . Up to 28 days

Measure: Length of ICU stay (days)

Time: up to 28 days

Measure: Mortality at Day 28

Time: Day 28

Measure: Change from baseline in ventilatory parameter (Tidal volume (TV))

Time: up to 28 days

Description: min score 0 max score 24

Measure: Delta Sequential Organ Failure Assessment (SOFA) Score

Time: up to 28 days

Measure: Incidence of all the AEs, AEs related to poractant alfa (treated cohort) (ADRs), serious AEs (SAEs) and AEs leading to death

Time: up to 28 days

Measure: Change from baseline in blood gas analysis acid-base balance parameter (pH)

Time: up to 28 days

Measure: Percentage of patients with PaO2/ FiO2 improvement of >20% following administration of each dose in the treated group and at similar timepoints in the control group

Time: at 6 and 12 hours following administration each dose in the treated group and at similar timepoints in the control group = up to 60 hours after the randomization

Measure: Number of Extracorporeal Membrane Oxygenation (ECMO)-free days- (only for cohort 2 of patients in ECMO)

Time: 21 days after randomization

Measure: Change from baseline in FiO2

Time: (6, 12, 30, 36, 54 and 60 hours after randomisation + every 24 hours after treatment/randomisation until the patient is discharged from the ICU = up to 28 days

Measure: Change from baseline in ventilatory parameter (respiratory rate (RR))

Time: up to 28 days

Measure: Change from baseline in ventilatory parameter (dynamic compliance (Cdyn))

Time: up to 28 days

Measure: Change from baseline in ventilatory parameter (static compliance (Cstat))

Time: up to 28 days

Measure: Change from baseline in ventilatory parameter (positive end-expiratory pressure (PEEP)

Time: up to 28 days

Measure: Change from baseline in ventilatory parameter (peak inspiratory pressure (PIP))

Time: up to 28 days

Measure: Change from baseline in ventilatory parameter (plateau pressure (Pplat))

Time: up to 28 days

Measure: Change from baseline in blood gas analysis acid-base balance parameter (pCO2)

Time: up to 28 days

Measure: Change from baseline in blood gas analysis acid-base balance parameter (pO2)

Time: up to 28 days

Measure: Change from baseline in blood gas analysis acid-base balance parameter (HCO3)

Time: up to 28 days

Measure: Change from baseline in blood gas analysis acid-base balance parameter (lactate)

Time: up to 28 days

No related HPO nodes (Using clinical trials)