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Completed

NCT Number: NCT04987606

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

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.

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Key information

Conditions

Pulmonary Fibrosis COVID-19 Pneumonia Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare Trust, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

POST COvid-19 Interstitial Lung DiseasE (POSTCODE) A Study of Genetic and Environmental Interactions: an Observational Cohort Study.

Acronym: POSTCODE

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 3, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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