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

COVID-19 Pneumonia Clinical Trial

— POSTCODE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987606
• Other study ID #: 21SM6765
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare Trust	London
United Kingdom	Royal Brompton Hospital	London
United Kingdom	University College London NHS Foundation Trust	London
United Kingdom	Manchester University NHS Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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	2 years