Covid 19 Clinical Trials

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.

NCT04375735 ARDS, Human COVID-19 Drug: Bovine Lipid Extract Surfactant

MeSH:Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: 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.

Measure: Adverse events (patient) - Decrease in oxygenation

Time: 3 days post-randomization

Description: 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.

Measure: Adverse events (patient) - Decrease in hemodynamics

Time: 3 days post-randomization

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

Measure: Adverse event (healthcare worker) - Circuit breach

Time: 3 days post-randomization

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

Measure: Adverse event (healthcare worker) - COVID-19 symptoms

Time: 2 weeks post-randomization

Secondary Outcomes

Description: PaO2 (in mmHg) / FiO2 (percentage oxygen expressed as a decimal) ratios captured from clinical chart

Measure: Change in oxygenation

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

Description: Lung compliance captured from the ventilators, expressed in mL/cm H2O.

Measure: Change in Lung compliance

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

Description: The number of days the patient is receiving mechanical ventilation.

Measure: Ventilated days

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

Description: The number of days the patient is admitted to the ICU

Measure: Length of ICU stay

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

Description: The number of days the patient is admitted to the hospital

Measure: Length of hospital stay

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

Description: Number of patients who die within 30 days of ICU admission

Measure: Mortality

Time: 30 days

Description: G-CSF, in pg/mL, from multiplex cytokine arrays

Measure: G-CSF levels (serum inflammatory biomarker)