A pilot study of lung ultrasound as point of care evaluation in post-COVID-19 patients

The evaluation of lung ultrasound as a new diagnostic tool for the assessment of patients following acute coronavirus (COVID-19) infection requiring hospitalisation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14376817

Enrollment

Registered

2021-01-06

Start date

2021-03-03

Completion date

Unknown

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post COVID-19 (SARS-CoV-2 infection) imaging surveillance Infections and Infestations

Interventions

Current interventions as of 03/03/2021: Lung Ultrasound (LUS) will be used to measure the improvement in subpleural interstitial changes related to COVID-19 infection in subjects follo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years 2. Positive sample for SARS-CoV-2 (detected by RT-PCR from a nasopharyngeal swab) 3. Admitted to hospital due to/with COVID-19 Added 03/03/2021: 4. Lung infiltrates on chest X-ray

Exclusion criteria

Exclusion criteria: At baseline: 1. Unable to mobilise independently 2. Visually or cognitively impaired 3. Unable to provide informed consent Added 08/01/2021: 4. Pregnancy Added 03/03/2021: 5. Allergy to CT contrast

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 03/03/2021: 1. The overall diagnostic accuracy of LUS as a test to identify pulmonary fibrosis as compared to CT thorax in post-COVID patients, assessed by calculating the sensitivity, specificity, positive predictive value, negative predictive values of LUS at Day 84 2. The utility of Lung Ultrasound (LUS) to sequentially monitor interstitial changes in the lungs of 20 patients who have recently recovered from COVID-19 pneumonia, assessed using a validated LUS scoring system at Days 1, Day 42 and Day 84 Previous primary outcome measure:: Lung fibrosis and interstitial changes measured using lung ultrasound (LUS) at Day 1 and Day 84	—

Measure

Time frame

Current primary outcome measure as of 03/03/2021: 1. The overall diagnostic accuracy of LUS as a test to identify pulmonary fibrosis as compared to CT thorax in post-COVID patients, assessed by calculating the sensitivity, specificity, positive predictive value, negative predictive values of LUS at Day 84 2. The utility of Lung Ultrasound (LUS) to sequentially monitor interstitial changes in the lungs of 20 patients who have recently recovered from COVID-19 pneumonia, assessed using a validated LUS scoring system at Days 1, Day 42 and Day 84 Previous primary outcome measure:: Lung fibrosis and interstitial changes measured using lung ultrasound (LUS) at Day 1 and Day 84

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Secondary

Measure	Time frame
Current secondary outcome measures as of 03/03/2021: The extent to which LUS provides additional predictive and prognostic information in assessing the rate of recovery of patients recently hospitalized with COVID-19. LUS scores at days 1, 42 and 84 will be correlated with: 1. Serum biomarkers (C-reactive protein, D dimers, lactate dehydrogenase, ferritin, full blood count, troponin) measured on Days 1, 42 and 84 2. Lung function measured using spirometry with gas transfer (FEV1 and FVC) at Days 42 and 84 3. Functional capacity measured with 6MWT at Day 84 4. Quality of life measured using EQ-5D as a surrogate measure of ‘wellness’ at days 42 and 84 5. SaO2% measured using pulse oximetry at Days 1-84 Previous secondary outcome measures: 1. Lung fibrosis and interstitial changes measured using CT scan at Day 84 2. Lung function measured using spirometry at Day 84	—

Measure

Time frame

Current secondary outcome measures as of 03/03/2021: The extent to which LUS provides additional predictive and prognostic information in assessing the rate of recovery of patients recently hospitalized with COVID-19. LUS scores at days 1, 42 and 84 will be correlated with: 1. Serum biomarkers (C-reactive protein, D dimers, lactate dehydrogenase, ferritin, full blood count, troponin) measured on Days 1, 42 and 84 2. Lung function measured using spirometry with gas transfer (FEV1 and FVC) at Days 42 and 84 3. Functional capacity measured with 6MWT at Day 84 4. Quality of life measured using EQ-5D as a surrogate measure of ‘wellness’ at days 42 and 84 5. SaO2% measured using pulse oximetry at Days 1-84 Previous secondary outcome measures: 1. Lung fibrosis and interstitial changes measured using CT scan at Day 84 2. Lung function measured using spirometry at Day 84

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026