Exploring Gas Transfer and the Utility of Dynamic Chest Radiography in Long Covid Patients

NCT05862896 | Unknown

• 1 other identifier: LHS0056
• Study Type: observational
• Target: 194
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to identify if breathless patients with Long COVID have reduced transfer factor on pulmonary function testing and if the degree of transfer factor reduction is correlated with the symptom severity and physiological ability to exercise. We will also investigate whether a new type of X-ray called a dynamic chest X-ray can identify perfusion abnormalities and whether these correlate with differences in diffusion capacity measured on a pulmonary function test.

Conditions

COVID-19

Keywords

Long COVID

Outcome Measures

Primary Outcomes (1)

• Primary objective

  1\) To establish the proportion of patients with long COVID that have abnormal transfer factor on pulmonary function testing.

  12 months

Study Arms (2)

Control

Healthy, age and sex matched controls

Long Covid

Patients with breathlessness (defined as self-reported modified Borg Scale score of 2 or more when walking on flat ground for 100 metres) that has continued or developed and persists more than 4 weeks after acute COVID 19 i.e., related to 'long COVID' (covid confirmed by photographic evidence of positive lateral flow/NHS application, EMIS records or hospital lab data).

Eligibility Criteria

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

Study Population

A group of adults (over 18 years) with breathlessness secondary to long COVID identified in the community will be compared with a control group of age and sex matched healthy volunteers.

You may qualify if:

• Adults (over 18 years old)
• Patients with breathlessness (defined as self-reported modified Borg Scale score of 2 or more when walking on flat ground for 100 metres) that has continued or developed and persists more than 4 weeks after acute COVID 19 i.e., related to 'long COVID' (covid confirmed by photographic evidence of positive lateral flow/NHS application, EMIS records or hospital lab data).
• Able to achieve positioning for a PA chest X-ray for a 20 second period
• Able to hold their breath for at least 7 seconds
• Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
• Able to provide written informed consent
• For control group: Age, sex matched to participants identified in the affected group

You may not qualify if:

• Any contraindication to pulmonary function testing or DCR
• Pregnancy
• For women of childbearing age, a positive pregnancy test or refusal of pregnancy test (a negative urinary pregnancy test on the day of DCR is a requirement)
• Significant other respiratory co-morbidities as judged by study clinician
• Significant research related radiation exposure in last 12 months prior to consent (from participation in a previous studies involving radiation exposure, with a research dose constraint of 0.4 mSv)
• Unable to provide informed consent for any reason
• For the long covid arm no evidence of a positive covid-19 test

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 17, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05