Clinical trial

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)

Name

CLI-050000-04

Description

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).

Trial arms

Trial start

2021-01-06

Estimated PCD

2022-03-17

Trial end

2022-03-17

Status

Terminated

Phase

Early phase I

Treatment

CUROSURF® (poractant alfa)

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.

Arms:

Poractant alfa

Size

Primary endpoint

Number of Days Alive and Ventilator-free Days

up to 21 days

Eligibility criteria

Inclusion Criteria: Participants were eligible to be included in the study if the following criteria apply: 1. Male or female ≥18 and ≤ 80 years of age 2. Informed consent for participation in the study (refer to section 15 for detailed inform consent procedure) 3. Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) before randomisation 4. Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio \< 150 mmHg 5. Lung compliance ≤45 ml/cmH20 6. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration Exclusion Criteria: Participants were excluded from the study if any of the following criteria apply: 1. Any contraindications to surfactant administration e.g., pulmonary hemorrhage and pneumothorax) 2. Weight \< 40kg 3. Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate (eGFR) \< 30) 4. Pregnancy 5. Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration 6. Extracorporeal membrane oxygenation (ECMO)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

Updated at

2023-06-23

1 organization

1 product

1 indication

Organization

Chiesi Farmaceutici

Product

CUROSURF

Indication

Acute Respiratory Distress Syndrome