Status:
TERMINATED
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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-1...
Detailed Description
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 rand...
Eligibility Criteria
Inclusion
- Participants were eligible to be included in the study if the following criteria apply:
- Male or female ≥18 and ≤ 80 years of age
- Informed consent for participation in the study (refer to section 15 for detailed inform consent procedure)
- Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) before randomisation
- Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio \< 150 mmHg
- Lung compliance ≤45 ml/cmH20
- Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration
Exclusion
- Participants were excluded from the study if any of the following criteria apply:
- Any contraindications to surfactant administration e.g., pulmonary hemorrhage and pneumothorax)
- Weight \< 40kg
- Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate (eGFR) \< 30)
- Pregnancy
- Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration
- Extracorporeal membrane oxygenation (ECMO)
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04502433
Start Date
January 6 2021
End Date
March 17 2022
Last Update
June 23 2023
Active Locations (6)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202
2
Chiesi site # 14
Bologna, Italy, 40138
3
Chiesi site #13
Modena, Italy, 41124
4
UCLH and UCL 250 Euston Road
London, United Kingdom, NW1 2BU