Pulmonary FibrosisPOSTCODENCT04987606
Post COVID-19 Interstitial Lung Disease: A Study of Genetic and Environmental Interactions
An observational study of Pulmonary Fibrosis and COVID-19 Pneumonia, run by Imperial College London at 4 sites in United Kingdom.
Trial summary
This study aims to understand why some people who have had COVID-19 develop scarring of the lungs and why some people recover more quickly than others. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulmonary Fibrosis, COVID-19 Pneumonia
- How many people
- 40 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Jul 2021to 1 Apr 2024
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with interstitial lung disease following COVID-19
Who may be able to join
- Evidence of SARS-CoV-2 PCR/Seropositive
- Presence of interstitial lung disease on CT
- Participant is willing and able to give informed consent for participation in the study
- Aged 18 years or above
Who cannot join
- Confirmed ILD diagnosis prior to March 2020
- Patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study.
- Use of steroids at baseline visit
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
University College London NHS Foundation Trust
London, NW1 2PG
Royal Brompton Hospital
London, SW3 6NP
Imperial College Healthcare Trust
London, W2 1BL
Manchester University NHS Trust
Manchester, M13 9WL
About this study
Official title: POST COvid-19 Interstitial Lung DiseasE (POSTCODE) A Study of Genetic and Environmental Interactions: an Observational Cohort Study.
This study aims to understand why some people who have had COVID-19 develop scarring of the lungs and why some people recover more quickly than others.
Read the detailed description
A large number of people diagnosed with COVID-19 suffer from long term symptoms, predominantly breathlessness and fatigue whether or not they were admitted to hospital. While there are a number of causes of long-term breathlessness following COVID-19 one of the most common, and potentially concerning with regards to long term prognosis is Interstitial Lung Disease.
The fibrogenic potential of SARS-CoV-2 is currently unknown but is predicted to be substantial based on the experience of previous coronavirus outbreaks and emerging data from this pandemic.
The investigators do not yet understand how scarring occurs following SARS-CoV-2, nor why there is resolution in some individuals and persistent or progressive disease in others. The investigators therefore plan to undertake bronchoscopy (camera test into the lungs) to examine for changes in the way the cells lining the lung behave, using genetics, and differences in the bacteria living in the airways in patients whom have developed scarring following COVID-19.
- Conditions
- Pulmonary Fibrosis, COVID-19 Pneumonia
- Medical subject headings
- Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the bacterial burden and composition of the respiratory microbiome in post covid fibrosis compared to health
The lower airway bacterial burden and microbiome will be characterised in patients with post covid fibrosis and compared to that of health.
Measured: 2 years
Secondary outcomes (1)
Change in bacterial burden over time in post covid fibrosis
Differences in the airway bacterial burden at baseline and one year following covid-19 infection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Jul 2021
- Primary completion1 Apr 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987606
- Sponsor's protocol ID
- 21SM6765
- Acronym
- POSTCODE
- Status last verified
- Apr 2024
- First submitted
- 19 Jul 2021
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POST COvid-19 Interstitial Lung DiseasE (POSTCODE) A Study of Genetic and Environmental Interactions: an Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT04987606
- Acronym / sponsor ID
- POSTCODE / 21SM6765
- Conditions
- Pulmonary Fibrosis, COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 3 Aug 2021 (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.
This study aims to understand why some people who have had COVID-19 develop scarring of the lungs and why some people recover more quickly than others.
Detailed description
A large number of people diagnosed with COVID-19 suffer from long term symptoms, predominantly breathlessness and fatigue whether or not they were admitted to hospital. While there are a number of causes of long-term breathlessness following COVID-19 one of the most common, and potentially concerning with regards to long term prognosis is Interstitial Lung Disease.
The fibrogenic potential of SARS-CoV-2 is currently unknown but is predicted to be substantial based on the experience of previous coronavirus outbreaks and emerging data from this pandemic.
The investigators do not yet understand how scarring occurs following SARS-CoV-2, nor why there is resolution in some individuals and persistent or progressive disease in others. The investigators therefore plan to undertake bronchoscopy (camera test into the lungs) to examine for changes in the way the cells lining the lung behave, using genetics, and differences in the bacteria living in the airways in patients whom have developed scarring following COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with interstitial lung disease following COVID-19
Key inclusion criteria (4 listed)
- Evidence of SARS-CoV-2 PCR/Seropositive
- Presence of interstitial lung disease on CT
- Participant is willing and able to give informed consent for participation in the study
- Aged 18 years or above
Key exclusion criteria (3 listed)
- Confirmed ILD diagnosis prior to March 2020
- Patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study.
- Use of steroids at baseline visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in the bacterial burden and composition of the respiratory microbiome in post covid fibrosis compared to health
Time frame: 2 years
The lower airway bacterial burden and microbiome will be characterised in patients with post covid fibrosis and compared to that of health.
1 secondary outcome
Change in bacterial burden over time in post covid fibrosis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis and COVID-19 Pneumonia, run by Imperial College London at 4 sites in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the bacterial burden and composition of the respiratory microbiome in post covid fibrosis compared to health (time frame: 2 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 18 Apr 2024.