Viral pneumonia, including COVID-19 Infections and Infestations
Conditions
Interventions
For the treatment arm, patients will be administered surfactant via COVSurf Drug Delivery System, they will receive 5 vials (540mg) of Alveofact® at a dosing time of 0 hours, 12, 24, 36 and 48 hours w
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old 2. Confirmed viral pneumonia (including COVID-19) 3. Within 48 hours of needing CPAP or NIV 4. Assent obtained from personnel (PerLR) or professional legal representative (ProfLR)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in PaO2/FiO2 ratio 48 hours after study initiation - assess the improvement in oxygenation as determined by the PaO2/FiO2 ratio 48 hours after study initiation; the PaO2/FiO2 ratio is measured by dividing the partial pressure of oxygen in arterial blood (PaO2) by the fraction of inspired oxygen (FiO2). PaO2 is measured through an arterial blood gas (ABG) test, while FiO2 represents the percentage of oxygen the patient is receiving, expressed as a decimal. 2. Need for invasive mechanical ventilation (IMV) measured using data recorded by the assessing clinician every day after study initiation 3. Feasibility of surfactant delivery measured using data recorded by the assessing clinician at all time points of surfactant delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess safety as judged by the frequency and severity of adverse events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) measured using data recorded by the assessing clinician daily over the first 28 days after study initiation 2. Mean change in PaO2/FiO2 ratio at 24 and 48 hours after study initiation at 24 and 48 hours after study initiation; the PaO2/FiO2 ratio is measured by dividing the partial pressure of oxygen in arterial blood (PaO2) by the fraction of inspired oxygen (FiO2). PaO2 is measured through an arterial blood gas (ABG) test, while FiO2 represents the percentage of oxygen the patient is receiving, expressed as a decimal. 3. To evaluate clinical improvement defined by time to one improvement point on an ordinal scale, as described in the WHO master protocol (2020), daily while hospitalised and on days 15 and 28, measured using data from daily assessments while hospitalised and on Days 15 and 28 4. The number of days of overall mechanical ventilation (NIV/CPAP and MV) measured using recorded data of days measured every day after study initiation 5. The number of days of ventilatory support (CPAP or NIV) measured using recorded data of days measured every day after study initiation 6. Ventilator support (CPAP/NIV or MV) free days at day 21, measured using recorded data of days measured every day after study initiation until day 21 7. Length of intensive care unit stay measured using recorded data of days measured every day after study initiation 8. The number of days hospitalised measured using recorded data of days measured every day after study initiation 9. Mortality at Day 28 measured using recorded data on day 28 after the study initiation | — |
Countries
England, United Kingdom
Contacts
Public ContactDanny Pratt
Outcome results
None listed