To Assess Surfactant Levels in Lung FluidNCT04609488
Surfactant Levels in the Lungs of COVID-19 Patients
An observational study of To Assess Surfactant Levels in Lung Fluid, run by Zealand University Hospital.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- To Assess Surfactant Levels in Lung Fluid
- What is being tested?
- Surfactant assessment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Being tested
- Surfactant assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant assessmentDiagnostic test
To determine surfactant levels in lung fluid
| Study group | Role | What they receive |
|---|---|---|
| COVID | Not described Receives: Diagnostic Test: Surfactant assessment | |
| non-COVID | Not described Receives: Diagnostic Test: Surfactant assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surfactant
The primary outcome is surfactant levels in lung fluid
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess Surfactant Levels in Lung FluidStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henning Bay Nielsen, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609488
- Sponsor's protocol ID
- SJ-859x
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Assess Surfactant Levels in COVID-19 Patients Who Will be on Ventilatory Support Due to Severe Respiratory Failure
- ClinicalTrials.gov ID
- NCT04609488
- Acronym / sponsor ID
- SJ-859x
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID | – | Diagnostic Test: Surfactant assessment |
| non-COVID | – | Diagnostic Test: Surfactant assessment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surfactant assessmentTo determine surfactant levels in lung fluid | Diagnostic test | COVID, non-COVID |
Primary outcome
Surfactant
Time frame: Two years
The primary outcome is surfactant levels in lung fluid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of To Assess Surfactant Levels in Lung Fluid, run by Zealand University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henning B Nielsen (004531365332, henningbay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surfactant (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.