Surfactant Levels in the Lungs of COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
NAME of STUDY: Surfactant levels in the lungs of COVID-19 patients BACKGROUND Infection with SARS-CoV-2 may induce respiratory failure. COVID-19 associated respiratory failure may require ventilatory support. SARS-CoV-2 uses alveolar type II cells for virus replication. Alveolar type II cells are responsible for surfactant production and lack of surfactant causes respiratory failure in preterm neonates. Lack of surfactant may play role for respiratory failure in COVID-19 patients DESIGN Exploratory prospective study design without therapeutic intervention of any kind. Lung fluid will be donated as part of standard care procedures. HYPOTHESIS Surfactant is measurable in tracheal secretions by mid-infrared FTIR spectroscopy determined surfactant spectra. Surfactant is reduced in COVID-19 patients requiring ventilator support as compared to non- COVID-19 patients. Dysfunctional surfactant in COVID-19 patients regain its function when respiratory function improves. POPULATION Main population is patients with COVID-19 pneumonia that requires ventilatory support. OUTCOME MEASURES Primary outcome is the level of surfactant in lung fluid as obtained by tracheal suction. SAMPLE SIZE In total 30 patients will be included: twenty COVID-19 patients and 10 non-COVID-19 patients.

Official Title
-----------------
An Exploratory Study to Assess Surfactant Levels in COVID-19 Patients Who Will be on Ventilatory Support Due to Severe Respiratory Failure

Conditions
-----------------
To Assess Surfactant Levels in Lung Fluid

Intervention / Treatment
-----------------
* Diagnostic Test: Surfactant assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients positive for coronavirus 2 (SARS-CoV-2) AND Respiratory failure requiring mechanical ventilation support OR respiratory failure requiring oxygen supplementation AND Age > 18 years AND Permission from next of kin Exclusion Criteria: Inability to obtain TS or BL as determined by clinical judgement by responsible clinician. Patients with known surfactant dysfunction (such as mutations in the SFTPB or ABCA3 gene). Imminent expected death within 24 hours. Stage 4 severe chronic kidney disease or requiring dialysis. Liver failure. Anticipated transfer to another hospital within 72 hours. Participation in another study which in the opinion of the investigator would prevent enrollment for safety purposes.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID<br> | Diagnostic Test: Surfactant assessment<br>* To determine surfactant levels in lung fluid<br>|
| non-COVID<br> | Diagnostic Test: Surfactant assessment<br>* To determine surfactant levels in lung fluid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surfactant | The primary outcome is surfactant levels in lung fluid | Two years |