Respiratory Infections Clinical Trial
— COVSurfOfficial title:
A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19
Verified date | September 2023 |
Source | University Hospital Southampton NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 require ventilation this substance does not function normally. This study will introduce surfactant to the patients lungs via the COVSurf Drug Delivery System
Status | Completed |
Enrollment | 20 |
Est. completion date | January 30, 2023 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London Hospitals NHS Foundation Trust | London | |
United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University Hospital Southampton NHS Foundation Trust | Bill and Melinda Gates Foundation, University College, London |
United Kingdom,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxygenation Improvement | To assess the improvement in oxygenation as determined by the PaO2/FiO2 ratio after treatment with study treatment | 3 months | |
Primary | Pulmonary ventilation Improvement | To assess the improvement in pulmonary ventilation as determined by the Ventilation Index (VI), where VI = (Respiratory rate X PIP X PaCo2 (mmHg)/ 1000 after study treatment. | 3 months | |
Primary | IMV Need | Need for invasive mechanical ventilation (IMV) (CPAP/NIV arm only) | 3 months | |
Secondary | Safety Assessment of Frequency and Severity of Adverse Events | To assess safety as judged by the frequency and severity of adverse events and severe adverse events (SAEs). | 3 months | |
Secondary | Change in PaO2/FiO2 ratio | Mean change in PaO2/FiO2 ratio at 24 and 48 hours after study initiation. | 3 months | |
Secondary | Mean Change in ventilatory index | Mean change in ventilatory index (VI) at 24 and 48 hours after study initiation | 48 hours | |
Secondary | Mean Change in pulmonary compliance | Mean change in pulmonary compliance (L/cmH2O) at 24 and 48 hours after study initiation in the IMV arm | 48 hours | |
Secondary | Mean Change in PEEP requirement | Mean change in PEEP (Positive End-Expiratory Pressure) requirement at 24 and 48 hours after study initiation | 48 Hours | |
Secondary | Clinical Improvement | 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 | 28 days | |
Secondary | Mechanical ventilation duration | Duration of mechanical ventilation | 3 months | |
Secondary | Duration of days | Duration of days of IMV or NIV or CPAP | 3 months | |
Secondary | IMV free days | Invasive Mechanical Ventilator (IMV) free days at day 21 | 21 days | |
Secondary | Ventilator support free days | Ventilator support (IMV or NIV or CPAP) free days (VSFD) at day 21 | 21 days | |
Secondary | Length of ICU stay | Length of intensive care unit stay | 3 months | |
Secondary | Number of days hospitalised | Number of days hospitalised | 3 months | |
Secondary | Mortality | Mortality at day 28 | 28 days |
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