Surfactant Levels in the Lungs of COVID-19 Patients

October 28, 2020 updated by: Henning Bay Nielsen, Zealand University Hospital

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

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible patients are COVID-19 patients requiring ventilatory support by mechanical ventilation as well as Non-COVID-19 patients requiring ventilatory support by mechanical ventilation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID
Diagnostic test: Surfactant assessment
To determine surfactant levels in lung fluid
non-COVID
Diagnostic test: Surfactant assessment
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

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2020

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (ACTUAL)

October 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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