Surfactant Levels in the Lungs of COVID-19 Patients
An Exploratory Study to Assess Surfactant Levels in COVID-19 Patients Who Will be on Ventilatory Support Due to Severe Respiratory Failure
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
COVID
|
To determine surfactant levels in lung fluid
|
|
non-COVID
|
To determine surfactant levels in lung fluid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surfactant
Time Frame: Two years
|
The primary outcome is surfactant levels in lung fluid
|
Two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJ-859x
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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