ClinicalTrials.gov

History of Changes for Study: NCT04375735
London's Exogenous Surfactant Study for COVID19 (LESSCOVID)
Latest version (submitted November 4, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 4, 2020 None (earliest Version on record)
2 June 9, 2020 Study Status, Eligibility, Oversight and Study Identification
3 November 4, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT04375735
Submitted Date:  May 4, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 9890
Brief Title: London's Exogenous Surfactant Study for COVID19 (LESSCOVID)
Official Title: London's Exogenous Surfactant Study for COVID19
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: May 1, 2020
Primary Completion: January 1, 2021 [Anticipated]
Study Completion: July 1, 2021 [Anticipated]
First Submitted: April 22, 2020
First Submitted that
Met QC Criteria:
May 4, 2020
First Posted: May 5, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 4, 2020
Last Update Posted: May 5, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Lawson Health Research Institute
Responsible Party: Sponsor
Collaborators: London Health Sciences Centre
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The research team is investigating administering exogenous surfactant in COVID-19 patients with ARDS. The overall goal is to improve the outcome (mortality) of mechanically ventilated COVID-19 patients. Although the investigators anticipate that clinical outcomes may improve in the small group of patients receiving exogenous surfactant therapy in this small, single center study, the primary goal is to first determine feasibility and safety.
Detailed Description:

The most severe patients infected by the virus that causes COVID-19 develop severe respiratory failure (called ARDS) and require mechanical ventilation in the intensive care unit to help maintain oxygen delivery to the blood. Often these patients further deteriorate while on mechanical ventilation. This trial will determine the feasibility and safety of a therapy that can potentially improve lung function, reduce the need for mechanical ventilation and hopefully impact mortality.

Adult patients with COVID-19 induced respiratory failure will be randomly assigned to receive either standard treatment or standard treatment plus exogenous surfactant. If enrolled in the latter, exogenous surfactant will be instilled into the lungs within 48 hours of intubation.

The study is founded on extensive research on ARDS for over 30 years, leading to evidence suggesting that exogenous surfactant administration may be beneficial in this disease. Importantly, exogenous surfactant is already utilized all over the world to reduce mortality in preterm infants. When tested in adults with ARDS, it was shown to be well tolerated and safe. Furthermore, clinical and laboratory evidence suggests that this therapy may be most effective in patients with a direct lung infection, and when administered shortly after the patient is intubated. In this study, twenty patients who are proven COVID-19 positive and require MV due to progressive respiratory failure will be randomized to receive either 1) exogenous surfactant (BLES) as soon as possible and within 48 hours of intubation and stabilization, or 2) treatment as usual (will not be treated with surfactant). The overall goal is to improve the outcome (mortality) of mechanically ventilated COVID-19 patients. Although the investigators anticipate that clinical outcomes may improve in the small group of patients receiving exogenous surfactant therapy in this small, single center study, the primary goal is to first determine feasibility and safety. Should the investigators obtain promising results, the data obtained from this study will be used to develop a large trial to test the impact of this therapy on the clinical outcomes, including mortality, associated with COVID-19.

Open or close this module Conditions
Conditions: ARDS, Human
COVID-19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Patients will be randomly assigned to either receive exogenous surfactant daily for 3 days, or receive standard treatment.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BLES treatment
For patients randomized to the treatment arm, exogenous BLES will be administered as soon as possible and within 48 hours of intubation. BLES will be administered daily for up to 3 doses, or until the patient is liberated from the ventilator.
Drug: Bovine Lipid Extract Surfactant
BLES will be administered in doses of 50mg/kg ideal bodyweight, at a concentration of 27mg/ml so a total volume of approximately 2ml/kg will be administered. The material will be instilled via the suction catheter through the ET tube so that the ventilation circuit is not broken. Half of the material will be instilled with the patient positioned on their left and right sides, with a pause to allow 5 min of MV between. The procedure will be repeated at, 24 and 48 hours while intubated, so the patient will receive up to 3 doses. To minimize aerosol generation, all patients will be paralyzed during surfactant administration and the ventilator will be paused. The proposed administration technique, surfactant concentration, volume and dosing schedule is based on previous studies, and has shown to be safe in patients with ARDS.
Other Names:
  • BLES
  • Lung Surfactant
  • Bovine
No Intervention: Control
Patients will receive standard treatment and will not receive surfactant.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Adverse events (patient) - Decrease in oxygenation
[ Time Frame: 3 days post-randomization ]

Count of any decreases in oxygenation, expressed as PaO2 (mmHg) / FiO2 (% oxygen as a decimal), of greater than 20% during the BLES treatment and up to 30 minutes post-treatment. Change will be calculated relative to pre-treatment values.
2. Adverse events (patient) - Decrease in hemodynamics
[ Time Frame: 3 days post-randomization ]

Count of any decrease in mean arterial blood pressure >10 mmHg or requirement for >20% increase in vasopressor dose during the BLES procedure and up to 30 minutes post-treatment. Change will be calculated relative to the pre-treatment values.
3. Adverse event (healthcare worker) - Circuit breach
[ Time Frame: 3 days post-randomization ]

Number of circuit breaches. Count of any circuit breach immediately prior to and during each BLES treatment procedure will be recorded.
4. Adverse event (healthcare worker) - COVID-19 symptoms
[ Time Frame: 2 weeks post-randomization ]

Count of healthcare personnel involved in the BLES procedure developing symptoms and testing positive for COVID-19.
Secondary Outcome Measures:
1. Change in oxygenation
[ Time Frame: Every 12 hours post-randomization until ICU discharge or death, whichever comes first, an average of 10 days and assessed up to 30 days. ]

PaO2 (in mmHg) / FiO2 (percentage oxygen expressed as a decimal) ratios captured from clinical chart
2. Change in Lung compliance
[ Time Frame: Every 12 hours post-randomization until ICU discharge or death, whichever comes first, an average of 10 days and assessed up to 30 days. ]

Lung compliance captured from the ventilators, expressed in mL/cm H2O.
3. Ventilated days
[ Time Frame: From ICU admission until ICU discharge or death, whichever comes first, an average of 10 days and assessed up to 30 days ]

The number of days the patient is receiving mechanical ventilation.
4. Length of ICU stay
[ Time Frame: From ICU admission until ICU discharge or death, whichever comes first, an average of 10 days and assessed up to 30 days ]

The number of days the patient is admitted to the ICU
5. Length of hospital stay
[ Time Frame: From hospital admission until hospital discharge or death, whichever comes first, assessed up to 60 days ]

The number of days the patient is admitted to the hospital
6. Mortality
[ Time Frame: 30 days ]

Number of patients who die within 30 days of ICU admission
7. G-CSF levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

G-CSF, in pg/mL, from multiplex cytokine arrays
8. GM-CSF levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

GM-CSF, in pg/mL, from multiplex cytokine arrays
9. IFN gamma levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

IFN gamma, in pg/mL, from multiplex cytokine arrays
10. IL-1 beta levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

IL-1 beta, in pg/mL, from multiplex cytokine arrays
11. IL-4 levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

IL-4, in pg/mL, from multiplex cytokine arrays
12. IL-6 levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

IL-6, in pg/mL, from multiplex cytokine arrays
13. IL-10 levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

IL-10, in pg/mL, from multiplex cytokine arrays
14. I levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

I, in pg/mL, from multiplex cytokine arrays
15. MCP-1 levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

MCP-1, in pg/mL, from multiplex cytokine arrays
16. TNF alpha levels (serum inflammatory biomarker)
[ Time Frame: ICU day 0, 1, 3 and 7 (7 days) ]

TNF alpha, in pg/mL, from multiplex cytokine arrays
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. age over 18 years
  2. definitive proof of COVID-19 infection within 48 hours of intubation
  3. acute respiratory failure with PaO2/FiO2 < 300 requiring intubation

Exclusion Criteria:

  1. known or high suspicion of pre-existing heart failure, unstable angina
  2. presence of severe shock with hemodynamic instability despite escalating vasopressors
  3. severe, underlying lung disease (COPD, pulmonary fibrosis, lung cancer. etc.)
  4. Concurrent treatments are delivered directly into the lung (ie anesthetics etc)
Open or close this module Contacts/Locations
Central Contact Person: Gordon Barkwell, MSc
Telephone: 519-685-8500 Ext. 55665
Email: gordon.barkwell@lhsc.on.ca
Central Contact Backup: Tracey Bentall
Telephone: 519-663-3150 Ext. 32546
Email: traceyc.bentall@lhsc.on.ca
Study Officials: Jim Lewis, MD
Principal Investigator
Lawson Health Research Institute
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services