Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
Stopped early · Phase 2
Conditions studied: Acute Respiratory Distress Syndrome
In brief
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).
Key facts
- Study ID
- NCT04502433
- Run by
- Chiesi Farmaceutici S.p.A.
- People needed
- 22
- Starts
- 2021-01-06
- Expected to finish
- 2022-03-17
- Last updated by the study team
- 2023-06-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Henry Ford Health System — Detroit, Michigan, United States
- Chiesi site # 14 — Bologna, Italy
- Chiesi site #13 — Modena, Italy
- UCLH and UCL 250 Euston Road — London, United Kingdom
- Chiesi site #4 — London, United Kingdom
- Chiesi site # 12 — Southampton, United Kingdom
Full record on ClinicalTrials.gov
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