Post COVID-19 Interstitial Lung Disease: A Study of Genetic and Environmental Interactions (POSTCODE)

April 17, 2024 updated by: Imperial College London

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

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

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • London, United Kingdom, NW1 2PG
        • University College London NHS Foundation Trust
      • London, United Kingdom, W2 1BL
        • Imperial College Healthcare Trust
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Trust

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with interstitial lung disease following COVID-19

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bacterial burden over time in post covid fibrosis
Time Frame: 2 years
Differences in the airway bacterial burden at baseline and one year following covid-19 infection
2 years

Collaborators and Investigators

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

Sponsor

Imperial College London

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 (Actual)

July 1, 2021

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21SM6765

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.

Clinical Trials on Pulmonary Fibrosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe