London's Exogenous Surfactant Study for COVID19 (LESSCOVID)

Lawson Health Research Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19; ARDS, Human

Treatments: Drug: Bovine Lipid Extract Surfactant

Study type: Interventional

Funder types: Other

Identifiers

NCT04375735

9890

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

BLES treatment

Experimental group

Description:

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.

Treatment:

Drug: Bovine Lipid Extract Surfactant

Control

No Intervention group

Description:

Patients will receive standard treatment and will not receive surfactant.