London's Exogenous Surfactant Study for COVID19

NCT04375735 | Completed Phase 1

• 1 other identifier: 9890
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

ARDS, Human; COVID-19

Outcome Measures

Primary Outcomes (4)

• Adverse events (patient) - Decrease in oxygenation

  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.

  3 days post-randomization

• Adverse events (patient) - Decrease in hemodynamics

  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 days post-randomization

• Adverse event (healthcare worker) - Circuit breach

  Number of circuit breaches. Count of any circuit breach immediately prior to and during each BLES treatment procedure will be recorded.

  3 days post-randomization

• Adverse event (healthcare worker) - COVID-19 symptoms

  Count of healthcare personnel involved in the BLES procedure developing symptoms and testing positive for COVID-19.

  2 weeks post-randomization

Secondary Outcomes (16)

• Change in oxygenation

  Every 12 hours post-randomization until ICU discharge or death, whichever comes first, an average of 10 days and assessed up to 30 days.

• Change in Lung compliance

  Every 12 hours post-randomization until ICU discharge or death, whichever comes first, an average of 10 days and assessed up to 30 days.

• Ventilated days

  From ICU admission until ICU discharge or death, whichever comes first, an average of 10 days and assessed up to 30 days

• Length of ICU stay

  From ICU admission until ICU discharge or death, whichever comes first, an average of 10 days and assessed up to 30 days

• Length of hospital stay

  From hospital admission until hospital discharge or death, whichever comes first, assessed up to 60 days

Study Arms (2)

BLES treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients will receive standard treatment and will not receive surfactant.

Interventions

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.

Also known as: BLES, Lung Surfactant, Bovine

BLES treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• London Health Sciences Centre: collaborator

Study Sites (2)

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Victoria Hospital

London, Ontario, Canada

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Interventions

Surface-Active Agents

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Jim Lewis, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to either receive exogenous surfactant daily for 3 days, or receive standard treatment.

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 5, 2020
• Study Start: November 23, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 6, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)