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.
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.
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 Name: Array
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)
5. Diagnosis of pulmonary hemorrhage
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Victoria Hospital
London, Ontario, Canada
Jim Lewis, MD, Principal Investigator
Lawson Health Research Institute