Surfactant Levels in the Lungs of COVID-19 Patients

• Conditions: To Assess Surfactant Levels in Lung Fluid
• Interventions: Diagnostic Test: Surfactant assessment

• Registration Number: NCT04609488
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Last Update Submitted: 2020-10-28
• Study First Posted: 2020-10-30
• Last Update Posted: 2020-10-30
• Study Start: 2020-11-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients positive for coronavirus 2 (SARS-CoV-2) AND
2. Respiratory failure requiring mechanical ventilation support OR respiratory failure requiring oxygen supplementation AND
3. Age > 18 years AND
4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-COVID	Surfactant assessment	-
COVID	Surfactant assessment	-

Primary Outcome Measures

Name	Time	Method
Surfactant	Two years	The primary outcome is surfactant levels in lung fluid