The UK Interstitial Lung Disease Long-COVID19 Study (UKILD-Long COVID): Understanding the Burden of Interstitial Lung Disease in Long COVID.

NCT05514522 | Unknown

• 1 other identifier: 21IC6978
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational study of hospitalised and non-hospitalised patients post- infection with SARS-CoV-2. The study aims to recruit 2000 individuals, with proven COVID-19, who were not hospitalised but presented to Long-COVID clinics with persistent respiratory symptoms such as breathlessness or cough and are referred for cross-sectional imaging (computer tomography, CT) at baseline (3 months weeks after their first COVID-19 symptoms). The study will run for 18 months.

Conditions

Interstitial Lung Disease; SARS-CoV-2 Infection

Keywords

Interstitial Lung Disease; COVID; PC-ILD population

Outcome Measures

Primary Outcomes (1)

• Examine and compare the prevalence of ILD in patients with varying severity of COVID-19

  Non-hospitalised will be compared with hospitalised patients and COVID severity defined as varying levels of respiratory support

  12 months

Secondary Outcomes (10)

• Determine progressive lung function impairment between 3 and 12 months

  12 months

• Resolution of ILD

  between 3 and 15 months post-acute SARS-CoV-2

• Persistence of ILD in those not meeting definition of progression or resolution

  between 3 and 15 months post-acute SARS-CoV-2

• Breathlessness

  3 month, 6 months (+/- 6 weeks) and 12 months (+/- 3 months) post SARS-CoV-2 infection

• Measure quality of life

  3 month, 6 months (+/- 6 weeks) and 12 months (+/- 3 months) post SARS-CoV-2 infection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community (Not Hospitalized) participants who have confirmed Evidence of SARS-CoV-2 infection between the age of 18 an 99 with a clinical indication for CT.

You may qualify if:

• Age \>18 years old -99 years old
• Evidence of SARS-CoV-2 infection confirmed by PCR or serology 3 months (+/- 6 weeks) earlier
• Clinical indication for a chest CT scan as per clinician judgment

You may not qualify if:

• Life-limiting illness within 12 months
• Significant pre-existing lung disease prior to March 2020, which in the investigator's judgement could make the chest CT scans difficult to interpret

Sponsors & Collaborators

• Imperial College London: lead
• Medical Research Council: collaborator
• University of Nottingham: collaborator
• University of Southampton: collaborator
• University of Leicester: collaborator
• University of Manchester: collaborator
• University of Liverpool: collaborator
• University of Sheffield: collaborator
• University of Oxford: collaborator
• University College, London: collaborator
• University of Newcastle Upon-Tyne: collaborator
• University of Edinburgh: collaborator

Study Sites (1)

Imperial College Healthcare trust

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be taken for plasma/ serum for epithelial and endothelial damage biomarkers, coagulation and genetics

MeSH Terms

Conditions

Lung Diseases, Interstitial; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Gisl Jenkins

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mark weeks, Dr

CONTACT

+44 (0)20 7594 7972; m.weeks@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 24, 2022
• Study Start: August 18, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)