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Completed

NCT Number: NCT04375735

London's Exogenous Surfactant Study for COVID19

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.

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Key information

Conditions

ARDS, Human COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

London Health Sciences Centre - University Hospital, London, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • known or high suspicion of pre-existing heart failure, unstable angina
  • presence of severe shock with hemodynamic instability despite escalating vasopressors
  • severe, underlying lung disease (COPD, pulmonary fibrosis, lung cancer. etc.)
  • Concurrent treatments are delivered directly into the lung (ie anesthetics etc)
  • Diagnosis of pulmonary hemorrhage

Treatment and study plan

Bovine Lipid Extract Surfactant

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • London Health Sciences Centre

Registry information

Official study title

Phase I/II Trial: Exogenous Surfactant Administration for Patients With COVID-19

Acronym: LESSCOVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 5, 2020
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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