Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)

Study Identifier:
CLI-050000-04
ClinicalTrials.gov Identifier:
NCT04502433
EudraCT Identifier:
2020-002632-75
EU CT ID:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn

Trial Documents

Protocol
Available Languages: English
Download document(s)
Statistical Analysis Plan
Available Languages: English
Download document(s)
Plain Language Summary
Available Languages: English, Italian
Download document(s)

Study Details

Medical Condition
  • Neonatal Respiratory Distress Syndrome
Study Drug
  • Drug: CUROSURF® (poractant alfa)
Date
Jan 2021 - Mar 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 80 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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)
Healthy Volunteers
No

Protocol 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-19 acute respiratory distress syndrome (ARDS).

Study Locations

Location
Status
Location
Henry Ford Health System
Detroit, Michigan, United States, 48202
Status
N/A
Location
Chiesi site # 14
Bologna, Italy, 40138
Status
N/A
Location
Chiesi site #13
Modena, Italy, 41124
Status
N/A
Location
UCLH and UCL 250 Euston Road
London, United Kingdom, NW1 2BU
Status
N/A
Location
Chiesi site #4
London, United Kingdom, SW10 9NH
Status
N/A
Location
Chiesi site # 12
Southampton, United Kingdom, SO16 6YD
Status
N/A