Status:
COMPLETED
A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
Bill and Melinda Gates Foundation
University College, London
Conditions:
Respiratory Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Lung surfactant is present in the lungs. It covers the alveolar surface where it reduces the work of breathing and prevents the lungs from collapsing. In some respiratory diseases and in patients that...
Detailed Description
The hypothesis behind the proposed trial of surfactant therapy for COVID-19 infected patients requiring ventilator support is that endogenous surfactant is dysfunctional. This could be due to decrease...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- Confirmed COVID-19 positive by PCR
- Within 24 hours of mechanical ventilation (ETI arm) or within 24 hours of needing either CPAP or NIV (CPAP/NIV arm)
- Assent or professional assent obtained
Exclusion
- Imminent expected death within 24 hours
- Specific contraindications to surfactant administration (e.g. known allergy, pneumothorax, pulmonary haemorrhage)
- Known or suspected pregnancy
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR \< 30)
- Liver failure
- Anticipated transfer to another hospital, which is not a study site within 72 hours.
- Current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes.
- Consent Declined
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04362059
Start Date
June 18 2020
End Date
January 30 2023
Last Update
September 29 2023
Active Locations (2)
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1
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
2
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU