COVID-19 Surfactant Clinical Trial [COVID-19]
Research type
Research Study
Full title
A clinical trial of nebulized surfactant for the Treatment of moderate to severe COVID-19 in adults
IRAS ID
282498
Contact name
Michael Grocott
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Eudract number
2020-001886-35
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
E/2020/0772, MHRA Correspondence Number
Duration of Study in the UK
0 years, 6 months, 6 days
Research 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 require ventilation this substance does not function normally. \n\nThe hypothesis behind this research is that a deficiency of functionally intact surfactant contributes to the deterioration in pulmonary function in patients with moderate to severe COVID-19. \nWe would like to find out whether administering doses of surfactant corrects this deficiency and leads to an improvement in lung function in patients with COVID-19. We would like to conduct an initial feasibility study to assess what dosing schedule produces the best response in patient’s that receive this treatment. To do this, patients will be randomised at a 3:2 ratio to receive treatment with the study drug or act as a control. Patients in the treatment arm will be allocated sequentially into one of four dosing groups with escalating dosing schedules. Patients in the control arm will not receive surfactant therapy. \n\nBovactant (Alveofact®) is the selected surfactant for this study. It will be adminstered via a modified nebuliser at Day 0 and again at 8 hours and 24 hours post first dose. The nebuliser is modified to generate particles of sufficiently small diameter which provides the potential to deliver significantly larger surfactant volumes for effective delivery to the lungs. The improvement in oxygenation and pulmonary ventilation will be measured. Safety data will be reviewed throughout the patient’s hospitalisation. \n\nPatients with COVID-19 that are hospitalised and require endotracheal intubation will be considered for inclusion in the study. 24 patients will be enroled in total across 2 sites.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0149
Date of REC Opinion
14 May 2020
REC opinion
Favourable Opinion