EUCTR2020-001886-35-GB
Active, not recruiting
Phase 1
A clinical trial of nebulized surfactant for the Treatment of moderate to severe COVID-19 in adults - COVID-19 Surfactant Clinical Trial
niversity Hospital Southampton NHS Foundation Trust0 sites20 target enrollmentMay 11, 2020
ConditionsCOVID-19 infection in patients requiring endotrachael intubationMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsAlveofact®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19 infection in patients requiring endotrachael intubation
- Sponsor
- niversity Hospital Southampton NHS Foundation Trust
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age \=18 years old
- •2\.Confirmed COVID\-19 positive by PCR
- •3\.Within 24 hours of mechanical ventilation
- •4\.Assent obtained from personnel (PerLR) or professional legal representative (ProfLR)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 10
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
Exclusion Criteria
- •1\.Imminent expected death within 24 hours
- •2\.Specific contraindications to surfactant administration (e.g. known allergy, pneumothorax, pulmonary haemorrhage)
- •3\.Known or suspected pregnancy
- •4\.Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR \< 30\)
- •5\.Liver failure (Child\-Pugh Class C)
- •6\.Anticipated transfer to another hospital, which is not a study site within 72 hours.
- •7\.Current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes.
- •8\.Consent declined
Outcomes
Primary Outcomes
Not specified
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