COVID-19 PneumoniaNCT05080257
Prognostic Value Of Chest Ultrasound (Lung Ultrasound Score) In COVID-19 Pneumonia Patients
An observational study of COVID-19 Pneumonia, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to 1. To study the prognostic value of LUS in COVID-19 patients. 2. To assess the relation between Lung Ultrasonography Score and disease severity in COVID-19 Patients. 3. To assess the relation between Lung Ultrasonography Score and mortality in COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Lung Ultrasonography
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2021to 1 Feb 2024
- 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: Sample size calculation will be carried out using G*Power 3 software , A minimum calculated sample of 60 COVID-19 cases will be needed to detect an effect size of 0.2 (22%-70%) vs (40%-93%) in the diagnostic yield (sensitivity and specificity) of lung US in severity of COVID-19 diagnosis, with an error probability of 0.05 and 80% power on a one-tailed test
Who may be able to join
- Age > 18.
- All Confirmed COVID-19 Patients by PCR or highly suspected patients admitted to the chest department's isolation unit during the duration of the study.
Who cannot join
- Age < 18.
- Heart Failure
- Chronic lung diseases with similar ultrasonographic findings to COVID-19 (ILD, Bronchiectasis, old T.B).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, 71111
Mohammed S Abdel-Qader, PhD, MD, 0201060507372, mohamed.saad85@yahoo.com
About this study
This study aims to
- To study the prognostic value of LUS in COVID-19 patients.
- To assess the relation between Lung Ultrasonography Score and disease severity in COVID-19 Patients.
- To assess the relation between Lung Ultrasonography Score and mortality in COVID-19 patients.
Read the detailed description
At the end of 2019, the COVID-19 pandemic broke out in Wuhan, China, and within few months -in March 2020- it was declared a pandemic by the WHO.
As of September 15th ,2021, there have been 226,844,344 confirmed cases of COVID-19, including 4,666,334 deaths, reported to WHO (1).
Due to the prevalence of COVID-19 and the financial burden it puts on the healthcare system, the use of a simple, affordable and reliable imaging modality was necessary.
The main idea in this research will be evaluating the value of Lung Ultrasonography Score in predicting the prognosis of patients with COVID-19 pneumonia and investigate the presence of a relation between the Lung Ultrasonography Score and patients' prognosis and mortality (2).
- Currently, Lung ultrasound had sensitivity 86%, specificity 71.6%, NPV 81.7%, and PPV 77.7%. The LUS had an area under the curve of 0.84 (95% CI 0.78, 0.90). When including examinations visualizing twelve lung areas, lung US had sensitivity 90.9% and specificity 75.6%, with NPV 87.2% and PPV 82.0% and an area under the curve of 0.89 (95% CI 0.83, 0.96). (3).
- In COVID-19 patients admitted in ED, LUS was a good predictor of death, ICU admission, and endotracheal intubation.
- Our main strategy will be enrolling patients admitted to the chest department's isolation unit, conduct clinical examination, laboratory investigations and imaging and conduct chest ultrasonography and calculate the Lung Ultrasonography Score of the patients and create a correlation between the Lung Ultrasonography score and their prognosis and mortality.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Lung Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasonographyDevice
The ultrasonography will be done using the curved probe of the SONOACE R3 SAMSUNG ultrasonography machine, SN: S0GYM3HCC00016M, manufacture date: 12-2012.
Assessment of lung condition using the Lung Ultrasonography Score (total score calculated from the 12 standard examined areas, from 0 to 3 in each area, with a minimum of 0 up to 36)
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Lung Ultrasonography Score and condition severity (inflammatory markers)
creation of a statistical relation between the Lung Ultrasonography Score and the severity of the condition, which is assessed by clinical examination and inflammatory markers.
Measured: through study completion, an average of 2 years.
Mortality
creation of a statistical relation between the Lung Ultrasonography Score and mortality.
Measured: Through study completion, an average of 2 years.
Secondary outcomes (3)
Ventilatory support.
creation of a statistical relation between the Lung Ultrasonography Score and the ventilatory support needed by the patients.
Measured: Through study completion, an average of 2 years.
Duration of hospital stay
Assessment of relation between Lung Ultrasonography Score and the duration of hospital stay.
Measured: Through study completion, an average of 2 years.
ICU Admission
Assessment of relation between Lung Ultrasonography Score and the ICU admission.
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start20 Oct 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Osama Mohammed Sleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080257
- Sponsor's protocol ID
- Prognostic value of LUS COVID
- Status last verified
- Sep 2022
- First submitted
- 6 Oct 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value Of Chest Ultrasound (Lung Ultrasound Score) In COVID-19 Pneumonia Patients
- ClinicalTrials.gov ID
- NCT05080257
- Acronym / sponsor ID
- Prognostic value of LUS COVID
- Conditions
- COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 15 Oct 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.
This study aims to
- To study the prognostic value of LUS in COVID-19 patients.
- To assess the relation between Lung Ultrasonography Score and disease severity in COVID-19 Patients.
- To assess the relation between Lung Ultrasonography Score and mortality in COVID-19 patients.
Detailed description
At the end of 2019, the COVID-19 pandemic broke out in Wuhan, China, and within few months -in March 2020- it was declared a pandemic by the WHO.
As of September 15th ,2021, there have been 226,844,344 confirmed cases of COVID-19, including 4,666,334 deaths, reported to WHO (1).
Due to the prevalence of COVID-19 and the financial burden it puts on the healthcare system, the use of a simple, affordable and reliable imaging modality was necessary.
The main idea in this research will be evaluating the value of Lung Ultrasonography Score in predicting the prognosis of patients with COVID-19 pneumonia and investigate the presence of a relation between the Lung Ultrasonography Score and patients' prognosis and mortality (2).
- Currently, Lung ultrasound had sensitivity 86%, specificity 71.6%, NPV 81.7%, and PPV 77.7%. The LUS had an area under the curve of 0.84 (95% CI 0.78, 0.90). When including examinations visualizing twelve lung areas, lung US had sensitivity 90.9% and specificity 75.6%, with NPV 87.2% and PPV 82.0% and an area under the curve of 0.89 (95% CI 0.83, 0.96). (3).
- In COVID-19 patients admitted in ED, LUS was a good predictor of death, ICU admission, and endotracheal intubation.
- Our main strategy will be enrolling patients admitted to the chest department's isolation unit, conduct clinical examination, laboratory investigations and imaging and conduct chest ultrasonography and calculate the Lung Ultrasonography Score of the patients and create a correlation between the Lung Ultrasonography score and their prognosis and mortality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample size calculation will be carried out using G*Power 3 software , A minimum calculated sample of 60 COVID-19 cases will be needed to detect an effect size of 0.2 (22%-70%) vs (40%-93%) in the diagnostic yield (sensitivity and specificity) of lung US in severity of COVID-19 diagnosis, with an error probability of 0.05 and 80% power on a one-tailed test
Key inclusion criteria (2 listed)
- Age > 18.
- All Confirmed COVID-19 Patients by PCR or highly suspected patients admitted to the chest department's isolation unit during the duration of the study.
Key exclusion criteria (3 listed)
- Age < 18.
- Heart Failure
- Chronic lung diseases with similar ultrasonographic findings to COVID-19 (ILD, Bronchiectasis, old T.B).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung UltrasonographyThe ultrasonography will be done using the curved probe of the SONOACE R3 SAMSUNG ultrasonography machine, SN: S0GYM3HCC00016M, manufacture date: 12-2012. Assessment of lung condition using the Lung Ultrasonography Score (total score calculated from the 12 standard examined areas, from 0 to 3 in each area, with a minimum of 0 up to 36) | Device | – |
Primary outcome
Correlation between Lung Ultrasonography Score and condition severity (inflammatory markers)
Time frame: through study completion, an average of 2 years.
creation of a statistical relation between the Lung Ultrasonography Score and the severity of the condition, which is assessed by clinical examination and inflammatory markers.
Mortality
Time frame: Through study completion, an average of 2 years.
creation of a statistical relation between the Lung Ultrasonography Score and mortality.
3 secondary outcomes
Ventilatory support.
Time frame: Through study completion, an average of 2 years.
Duration of hospital stay
Time frame: Through study completion, an average of 2 years.
ICU Admission
Time frame: Through study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- WHO dashboard for updated COVID-19 statisticsLink provided by the sponsor.
- 3- Brenner, D.S., Liu, G.Y., Omron, R. et al. Diagnostic accuracy of lung ultrasound for SARS-CoV-2: a retrospective cohort study. Ultrasound J 13, 12 (2021)Link provided by the sponsor.
- 4- Faul, F., Erdfelder, E., Lang, A.-G. \& Buchner, A. (2007). G\*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191Link provided by the sponsor.
- 5- de Alencar, J.C.G., Marchini, J.F.M., Marino, L.O. et al. Lung ultrasound score predicts outcomes in COVID-19 patients admitted to the emergency department. Ann. Intensive Care 11, 6 (2021). https://doi.org/10.1186/s13613-020-00799-wLink provided by the sponsor.
- 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.
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 COVID-19 Pneumonia, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim O Sleem, BMBS (0201008955986, karimosama81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Lung Ultrasonography Score and condition severity (inflammatory markers) (time frame: through study completion, an average of 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2022.