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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 : Recruiting
First Posted : April 24, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
University College, London
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Study Description
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Brief 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. This study will introduce surfactant to the patients lungs via the COVSurf Drug Delivery System

Condition or disease Intervention/treatment Phase
Respiratory Infections Device: COVSurf Drug Delivery System Other: Standard of Care Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : July 27, 2021
Estimated Study Completion Date : November 16, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Oxygenation Improvement [ Time Frame: 3 months ]
    To assess the improvement in oxygenation as determined by the PaO2/FiO2 ratio after treatment with study treatment

  2. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years old
  • Confirmed COVID-19 positive by PCR
  • Within 24 hours of mechanical ventilation
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Danny B Pratt 02381204989 ext 3943 danny.pratt@uhs.nhs.uk

Locations
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United Kingdom
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Danny Pratt    02381204989    danny.pratt@uhs.nhs.uk   
Principal Investigator: Ahilanandan Dushianthan         
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2BU
Contact: Subarna Roy       subarna.roy@nhs.net   
Principal Investigator: Howard Clark         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Bill and Melinda Gates Foundation
University College, London
Investigators
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Principal Investigator: Michael P Grocott, MD University Hospital Southampton NHS Foundation Trust
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04362059    
Other Study ID Numbers: RHM CRI0399
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infections
Respiratory Tract Diseases