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

Completed

• Conditions: Pulmonary Fibrosis; COVID-19 Pneumonia

• Registration Number: NCT04987606
• Lead Sponsor: Imperial College London

Brief 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.

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 Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-03
• Primary Completion: 2023-04-01
• Status Verified: 2024-04
• Study Completion: 2024-04-01
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in the bacterial burden and composition of the respiratory microbiome in post covid fibrosis compared to health	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 Outcome Measures

Name	Time	Method
Change in bacterial burden over time in post covid fibrosis	2 years	Differences in the airway bacterial burden at baseline and one year following covid-19 infection

Trial Locations

Locations (4)

University College London NHS Foundation Trust; 🇬🇧 London, United Kingdom

Imperial College Healthcare Trust; 🇬🇧 London, United Kingdom

Manchester University NHS Trust; 🇬🇧 Manchester, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom