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Surfactant Levels in the Lungs of COVID-19 Patients

NCT ID: NCT04609488

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-10-01

Brief Summary

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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

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Conditions

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To Assess Surfactant Levels in Lung Fluid

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID

Surfactant assessment

Intervention Type DIAGNOSTIC_TEST

To determine surfactant levels in lung fluid

non-COVID

Surfactant assessment

Intervention Type DIAGNOSTIC_TEST

To determine surfactant levels in lung fluid

Interventions

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Surfactant assessment

To determine surfactant levels in lung fluid

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Henning Bay Nielsen

MD DMSci adj Professor specialist consultant Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Henning B Nielsen

Role: CONTACT

Phone: 004531365332

Email: [email protected]

Other Identifiers

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SJ-859x

Identifier Type: -

Identifier Source: org_study_id