NCT04362059: COVSurf

A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19

Completed NA Last updated 29 September 2023

What this trial tests

NA trial testing COVSurf Drug Delivery System in Respiratory Infections in 20 participants. Completed in 30 January 2023.

Timeline

18 June 2020

Primary endpoint
30 November 2022

30 January 2023

Quick facts

Lead sponsor	University Hospital Southampton NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	18 June 2020
Primary completion	30 November 2022
Estimated completion	30 January 2023
Sites	2 locations across United Kingdom

Drugs / interventions tested

• COVSurf Drug Delivery System
• Standard of Care

Conditions studied

• Respiratory Infections — all drugs for Respiratory Infections →

Sponsor

University Hospital Southampton NHS Foundation Trust

Who can join

18 and older, any sex, with Respiratory Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19 and Toll-Like Receptor 4 (TLR4): SARS-CoV-2 May Bind and Activate TLR4 to Increase ACE2 Expression, Facilitating Entry and Causing Hyperinflammation.
   Aboudounya MM, Heads RJ. · · 2021 · cited 267× · PMID 33505220 · DOI 10.1155/2021/8874339
2. The Role of Pulmonary Surfactants in the Treatment of Acute Respiratory Distress Syndrome in COVID-19.
   Wang S, Li Z, Wang X, Zhang S, et al · · 2021 · cited 36× · PMID 34267664 · DOI 10.3389/fphar.2021.698905
3. Alveolar type II cells and pulmonary surfactant in COVID-19 era.
   Calkovska A, Kolomaznik M, Calkovsky V. · · 2021 · cited 31× · PMID 34913352 · DOI 10.33549/physiolres.934763
4. Assessment of pulmonary surfactant in COVID-19 patients.
   Schousboe P, Wiese L, Heiring C, Verder H, et al · · 2020 · cited 27× · PMID 32894160 · DOI 10.1186/s13054-020-03268-9
5. Surfactant replacement might help recovery of low-compliance lung in severe COVID-19 pneumonia.
   Busani S, Dall'Ara L, Tonelli R, Clini E, et al · · 2020 · cited 21× · PMID 32865137 · DOI 10.1177/1753466620951043
6. Nebulised surfactant for the treatment of severe COVID-19 in adults (COV-Surf): A structured summary of a study protocol for a randomized controlled trial.
   Dushianthan A, Clark H, Madsen J, Mogg R, et al · · 2020 · cited 15× · PMID 33302976 · DOI 10.1186/s13063-020-04944-5
7. Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
   Mathioudakis AG, Fally M, Hashad R, Kouta A, et al · · 2020 · cited 14× · PMID 33333777 · DOI 10.3390/life10120350
8. Rapid Phospholipid Turnover after Surfactant Nebulization in Severe COVID-19 Infection: A Randomized Clinical Trial.
   Postle AD, Clark HW, Fink J, Madsen J, et al · · 2022 · cited 12× · PMID 34874818 · DOI 10.1164/rccm.202110-2279le