Covid19NCT05062603
Lung Ultrasound Changes in Covid 19 Patients Discharged From Hospital
An observational study of Covid19 and Coronavirus, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Lung ultrasound has been used to help diagnose COVID-19 as an alternative to CT scanning and chest X-ray. CT scanning is onerous and there are difficulties taking critically unwell patients there as well as decontamination issues. Chest X-ray misses up to 40% of COVID diagnoses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Coronavirus, Coronavirus Infection
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jul 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a confirmed COVID-19 viral infection.
Who may be able to join
- 18 years old or older
- Confirmed COVID-19 positive with changes on CXR or CT scan
- Having had an initial lung ultrasound in the Emergency department when they were first admitted into the hospital.
Who cannot join
- Pre-existing lung disease
- Heart failure
- Under 18 years old.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital
London, Greater London, SW10 9NH
About this study
Official title: Prospective Observational Study Looking at Lung Ultrasound Changes During Recovery From COVID19 Infection
Lung ultrasound has been used to help diagnose COVID-19 as an alternative to CT scanning and chest X-ray. CT scanning is onerous and there are difficulties taking critically unwell patients there as well as decontamination issues.
Chest X-ray misses up to 40% of COVID diagnoses. Although lung ultrasound can diagnose, the investigators do not know how long these lung ultrasound changes last. The investigators would like to follow up patients to characterise the pattern of changes and how long they last. This is particularly important given a potential second surge of COVID-19 is looming and the investigators would like to know if lung ultrasound changes are new or old in patients presenting during this second wave and in the future.
Read the detailed description
Ultrasound has been invaluable during this pandemic to diagnose COVID-19. The investigators have used it alongside CT scanning to rationalise the number of CT scans especially when patients are unstable. The investigators do not know how long these changes last on lung ultrasound after discharge and the investigators wish to study this.
This is because patients will start presenting shortly who have a history of COVID-19 with acute medical problems and if the investigators are to use lung ultrasound again the investigators would like to know whether the changes the investigators see are new or old.
This is vitally important before a second surge and especially so before winter. This may also facilitate triage of patients from the front door in the Emergency department to different areas (such as COVID-19 zones or clean areas).
- Conditions
- Covid19, Coronavirus, Coronavirus Infection, SARS-CoV Infection
- Keywords
- Coronavirus, COVID-19, Lung ultrasound, Respiratory
- Medical subject headings
- COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of lung ultrasound changes over the time period of follow up.
The assessment will determine how long it takes for lung ultrasound changes to resolve following discharge from hospital in patients who were diagnosed with COVID-19 (unit of measurement: days).
Measured: Approximately 3 months or until the ultrasound changes in the lung had normalised
Secondary outcomes (1)
Exploration of ongoing symptoms
Ongoing symptoms will be explored by using screening questions.
Measured: Approximately 3 months or until the ultrasound changes in the lung had normalised
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start9 Jul 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paramjeet Deol, MBChB FRCEM, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062603
- Sponsor's protocol ID
- C&W20/036
- Other IDs
- IRAS number 286015
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Poggiali E, Dacrema A, Bastoni D, Tinelli V, Demichele E, Mateo Ramos P, Marciano T, Silva M, Vercelli A, Magnacavallo A. Can Lung US Help Critical Care Clinicians in the Early Diagnosis of Novel Coronavirus (COVID-19) Pneumonia? Radiology. 2020 Jun;295(3):E6. doi: 10.1148/radiol.2020200847. Epub 2020 Mar 13. No abstract available.
PubMed 32167853Huang Yi, Sihan Wangm Yue Liu, Yaohui Zhang, Chuyun Zheng, Yu Zheng, CHaoyang Zhangm et al. A preliminary study on the ultrasonic manifestations of Peripulmonary lesions of non-critical Novel Coronavirus Pneumonia (Covid-19).
Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.
PubMed 32166346
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Looking at Lung Ultrasound Changes During Recovery From COVID19 Infection
- ClinicalTrials.gov ID
- NCT05062603
- Acronym / sponsor ID
- C&W20/036
- Conditions
- Covid19, Coronavirus, Coronavirus Infection, SARS-CoV Infection
- Keywords
- Coronavirus, COVID-19, Lung ultrasound, Respiratory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung ultrasound has been used to help diagnose COVID-19 as an alternative to CT scanning and chest X-ray. CT scanning is onerous and there are difficulties taking critically unwell patients there as well as decontamination issues.
Chest X-ray misses up to 40% of COVID diagnoses. Although lung ultrasound can diagnose, the investigators do not know how long these lung ultrasound changes last. The investigators would like to follow up patients to characterise the pattern of changes and how long they last. This is particularly important given a potential second surge of COVID-19 is looming and the investigators would like to know if lung ultrasound changes are new or old in patients presenting during this second wave and in the future.
Detailed description
Ultrasound has been invaluable during this pandemic to diagnose COVID-19. The investigators have used it alongside CT scanning to rationalise the number of CT scans especially when patients are unstable. The investigators do not know how long these changes last on lung ultrasound after discharge and the investigators wish to study this.
This is because patients will start presenting shortly who have a history of COVID-19 with acute medical problems and if the investigators are to use lung ultrasound again the investigators would like to know whether the changes the investigators see are new or old.
This is vitally important before a second surge and especially so before winter. This may also facilitate triage of patients from the front door in the Emergency department to different areas (such as COVID-19 zones or clean areas).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a confirmed COVID-19 viral infection.
Key inclusion criteria (3 listed)
- 18 years old or older
- Confirmed COVID-19 positive with changes on CXR or CT scan
- Having had an initial lung ultrasound in the Emergency department when they were first admitted into the hospital.
Key exclusion criteria (3 listed)
- Pre-existing lung disease
- Heart failure
- Under 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of lung ultrasound changes over the time period of follow up.
Time frame: Approximately 3 months or until the ultrasound changes in the lung had normalised
The assessment will determine how long it takes for lung ultrasound changes to resolve following discharge from hospital in patients who were diagnosed with COVID-19 (unit of measurement: days).
1 secondary outcome
Exploration of ongoing symptoms
Time frame: Approximately 3 months or until the ultrasound changes in the lung had normalised
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 32167853Poggiali E, Dacrema A, Bastoni D, Tinelli V, Demichele E, Mateo Ramos P, Marciano T, Silva M, Vercelli A, Magnacavallo A. Can Lung US Help Critical Care Clinicians in the Early Diagnosis of Novel Coronavirus (COVID-19) Pneumonia? Radiology. 2020 Jun;295(3):E6. doi: 10.1148/radiol.2020200847. Epub 2020 Mar 13. No abstract available.
- BackgroundHuang Yi, Sihan Wangm Yue Liu, Yaohui Zhang, Chuyun Zheng, Yu Zheng, CHaoyang Zhangm et al. A preliminary study on the ultrasonic manifestations of Peripulmonary lesions of non-critical Novel Coronavirus Pneumonia (Covid-19).
- Background: PubMed 32166346Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paramjeet Deol, MBChB FRCEM principal investigator
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Coronavirus, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of lung ultrasound changes over the time period of follow up. (time frame: Approximately 3 months or until the ultrasound changes in the lung had normalised). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05062603, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.