A Clinical Trial of Nebulized Bovactant (Alveofact ®) for the Treatment of Moderate to Severe COVID-19

Phase 1

Active, not recruiting

Conditions: COVID-19 infection in patients requiring endotrachael intubation
MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2020-001886-35-GB

Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether administration of surfactant therapy via the modified Aerogen nebuliser results in improved PaO2/FiO2 ratio and ventilation index in patients with COVID-19 after last dose of surfactant and the optimal dosing schedule to be used.;Secondary Objective: To assess the safety of surfactant therapy via the modified Aerogen nebuliser and mean clinical improvement of patients with COVID-19 following administration.;Primary end point(s): <br>Change in PaO2/FiO2 ratio at 48 hours after study initiation.<br><br>Change in the Ventilation Index at 48 hours after study initiation.;Timepoint(s) of evaluation of this end point: 48 hours after study initiation

Secondary Outcome Measures