Surfactant Levels in the Lungs of COVID-19 Patients

To Assess Surfactant Levels in Lung Fluid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04609488
• Other study ID #: SJ-859x
• Status: Not yet recruiting
• Start date: November 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2020
• Source: Zealand University Hospital
• Contact: Henning B Nielsen
• Phone: 004531365332
• Email: henningbay[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• To Assess Surfactant Levels in Lung Fluid

Intervention

Diagnostic Test:
• Surfactant assessment
To determine surfactant levels in lung fluid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surfactant	The primary outcome is surfactant levels in lung fluid	Two years