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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04609488
Enrollment
30
Registered
2020-10-30
Start date
2020-11-01
Completion date
2022-10-01
Last updated
2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To Assess Surfactant Levels in Lung Fluid

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.

Interventions

DIAGNOSTIC_TESTSurfactant assessment

To determine surfactant levels in lung fluid

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
SurfactantTwo yearsThe primary outcome is surfactant levels in lung fluid

Contacts

Primary ContactHenning B Nielsen
henningbay@hotmail.com004531365332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026