A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19 (COVSurf)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04362059|
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Infections||Device: COVSurf Drug Delivery System Other: Standard of Care||Not Applicable|
The hypothesis behind the proposed trial of surfactant therapy for COVID-19 infected patients requiring ventilator support is that endogenous surfactant is dysfunctional. This could be due to decreased concentration of surfactant phospholipid and protein, altered surfactant phospholipid composition, surfactant protein proteolysis and/or oedema protein inhibition of surfactant surface tension function and/or oxidative inactivation of surfactant proteins. Variations of these dysfunctional mechanisms have been reported in a range of lung diseases, including cystic fibrosis and severe asthma, and in child and adult patients with ARDS. Our studies of surfactant metabolism in adult ARDS patients showed altered percentage composition of surfactant PC, with decreased DPPC and increased surface tension-inactive unsaturated species, and decreased concentrations of both total PC and phosphatidylglycerol (PG)
The SARS-CoV-2 virus binds to the angiotensin converting enzyme-2 (ACE2) receptor, which is preferentially expressed in the peripheral lung ATII cells. Consequent viral infection of ATII cells could reduce cell number and impair the capacity of the lungs to synthesise and secrete surfactant. This, however, has not yet been demonstrated empirically in COVID-19 patients. If this is the case, then exogenous surfactant administration to the lungs is potential one treatment option to mitigate disease severity in these patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19|
|Estimated Study Start Date :||June 27, 2020|
|Estimated Primary Completion Date :||July 27, 2020|
|Estimated Study Completion Date :||November 2, 2020|
Experimental: Treatment Arm
Patients will be administered surfactant via COVSurf Drug Delivery System
Device: COVSurf Drug Delivery System
Device introduces surfactant to the patients lungs
Active Comparator: Control Arm
Patients shall receive regular Standard of Care treatment
Other: Standard of Care
Standard of care treatment for respiratory illness
- Oxygenation Improvement [ Time Frame: 3 months ]To assess the improvement in oxygenation as determined by the PaO2/FiO2 ratio after treatment with study treatment
- Pulmonary ventilation Improvement [ Time Frame: 3 months ]To assess the improvement in pulmonary ventilation as determined by the Ventilation Index (VI), where VI = [RR x (PIP − PEEP) × PaCO2]/1000 after study treatment.
- Safety Assessment of Frequency and Severity of Adverse Events [ Time Frame: 3 months ]To assess safety as judged by the frequency and severity of adverse events and severe adverse events (SAEs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362059
|Contact: Danny B Pratt||02381204989 ext firstname.lastname@example.org|
|Principal Investigator:||Michael P Grocott, MD||University Hospital Southampton NHS Foundation Trust|