COVID-19POCUSNCT04384055
Predicting Outcomes for Covid-19 Using Sonography
An observational study of COVID-19 and Pneumonia, Viral, run by Stanford University at 2 sites in United States.
Trial summary
This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify Covid-19 pneumonia or patients at risk for deterioration early in the disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Pneumonia, Viral
- What is being tested?
- Lung Ultrasound
- How many people
- 165 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2020to 15 Nov 2021
- 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: This population will include all persons under investigation (PUIs) for covid-19 presenting to the Stanford emergency department.
Who may be able to join
- Any adult (18 or more years of age) presenting to the emergency department with symptoms suspicious for Covid-19
- This individual underwent evaluation for Covid-19 via a nasopharyngeal RT-PCR
- This individual received a lung ultrasound by the study authors within 28 days from initial evaluation
Who cannot join
- Any individual who did not receive a lung ultrasound within 28 days from initial evaluation for covid-19 related illness
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Francisco
San Francisco, California, 94117
Stanford University
Stanford, California, 95401
About this study
This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify Covid-19 pneumonia or patients at risk for deterioration early in the disease course.
Read the detailed description
As Covid-19 continues to stress hospital-based resources (including personal protective equipment, ancillary staff availability, and imaging study utilization), it is important to assess whether alternative methods for evaluating patients can be utilized to appropriately triage and care for Covid-positive patients. Current limitations of caring for patients with Covid-19 include the exposure of ancillary healthcare workers (including radiological technicians) and the time/resources required to decontaminate traditional radiological equipment such as x-ray or computerized tomography (CT) machines.
Point-of-care ultrasound (POCUS) has the potential to transform healthcare delivery due to its diagnostic and therapeutic expediency. It can be quickly performed at the bedside by experienced clinicians. It it has been shown to reliably and accurately diagnose patients with a variety of lung diseases, including pneumonia. This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify the virus or patients at risk for deterioration early in the disease course. Moreover, it has the potential to reduce the need for x-rays or CTs for Covid-19 patients, which has the potential to alleviate a significant burden currently being placed on the healthcare system.
- Conditions
- COVID-19, Pneumonia, Viral
- Being tested
- Lung Ultrasound
- Medical subject headings
- COVID-19, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundDiagnostic test
Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 Positive Patients | This group includes individuals who were diagnosed with Covid-19 based on reverse transcriptase polymerase chain reaction (RT-PCR) of the nasopharynx Receives: Diagnostic Test: Lung Ultrasound | |
| Covid-19 Negative Patients | This group includes individuals who did NOT have a positive test for Covid-19 based on reverse transcriptase polymerase chain reaction (RT-PCR) of the nasopharynx. Receives: Diagnostic Test: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula
Composite primary outcome of death, ICU admission, mechanical ventilation, or use of high-flow nasal cannula (categorical)
Measured: 28 days from initial evaluation
Secondary outcomes (5)
Number of Patients Requiring Mechanical Ventilation
Measured: 28 days from initial evaluation
Number of Patients Requiring Supplemental Oxygen Usage
Measured: 28 days from initial evaluation
Duration of Supplemental Oxygen Usage
Measured: 28 days from initial evaluation
Length of Stay
Duration of Hospitalization (days)
Measured: 28 days from initial evaluation
Characterization of Ultrasound Findings
Descriptive analysis of ultrasound findings in Covid-19
Measured: 28 days from initial evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start21 Mar 2020
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Stanford 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-control
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre D Kumar, MD, MEd, Principal investigator, Stanford UniversitySally Graglia, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384055
- Sponsor's protocol ID
- IRB-55621
- Acronym
- POCUS
- Status last verified
- Dec 2021
- First submitted
- 8 May 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Outcomes for Covid-19 Using Sonography
- ClinicalTrials.gov ID
- NCT04384055
- Acronym / sponsor ID
- POCUS / IRB-55621
- Conditions
- COVID-19, Pneumonia, Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 21 Mar 2020 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 12 May 2020 (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 seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify Covid-19 pneumonia or patients at risk for deterioration early in the disease course.
Detailed description
As Covid-19 continues to stress hospital-based resources (including personal protective equipment, ancillary staff availability, and imaging study utilization), it is important to assess whether alternative methods for evaluating patients can be utilized to appropriately triage and care for Covid-positive patients. Current limitations of caring for patients with Covid-19 include the exposure of ancillary healthcare workers (including radiological technicians) and the time/resources required to decontaminate traditional radiological equipment such as x-ray or computerized tomography (CT) machines.
Point-of-care ultrasound (POCUS) has the potential to transform healthcare delivery due to its diagnostic and therapeutic expediency. It can be quickly performed at the bedside by experienced clinicians. It it has been shown to reliably and accurately diagnose patients with a variety of lung diseases, including pneumonia. This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify the virus or patients at risk for deterioration early in the disease course. Moreover, it has the potential to reduce the need for x-rays or CTs for Covid-19 patients, which has the potential to alleviate a significant burden currently being placed on the healthcare system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 Positive Patients | – | Diagnostic Test: Lung UltrasoundThis group includes individuals who were diagnosed with Covid-19 based on reverse transcriptase polymerase chain reaction (RT-PCR) of the nasopharynx |
| Covid-19 Negative Patients | – | Diagnostic Test: Lung UltrasoundThis group includes individuals who did NOT have a positive test for Covid-19 based on reverse transcriptase polymerase chain reaction (RT-PCR) of the nasopharynx. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This population will include all persons under investigation (PUIs) for covid-19 presenting to the Stanford emergency department.
Key inclusion criteria (3 listed)
- Any adult (18 or more years of age) presenting to the emergency department with symptoms suspicious for Covid-19
- This individual underwent evaluation for Covid-19 via a nasopharyngeal RT-PCR
- This individual received a lung ultrasound by the study authors within 28 days from initial evaluation
Key exclusion criteria (1 listed)
- Any individual who did not receive a lung ultrasound within 28 days from initial evaluation for covid-19 related illness
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 UltrasoundLung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR. | Diagnostic test | Covid-19 Negative Patients, Covid-19 Positive Patients |
Primary outcome
Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula
Time frame: 28 days from initial evaluation
Composite primary outcome of death, ICU admission, mechanical ventilation, or use of high-flow nasal cannula (categorical)
5 secondary outcomes
Number of Patients Requiring Mechanical Ventilation
Time frame: 28 days from initial evaluation
Number of Patients Requiring Supplemental Oxygen Usage
Time frame: 28 days from initial evaluation
Duration of Supplemental Oxygen Usage
Time frame: 28 days from initial evaluation
Length of Stay
Time frame: 28 days from initial evaluation
Characterization of Ultrasound Findings
Time frame: 28 days from initial evaluation
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 3 Dec 2021.
- 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.
Andre D Kumar, MD, MEd principal investigator
Stanford University
Sally Graglia, MD, MPH principal investigator
University of California, San Francisco
2 sites 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 and Pneumonia, Viral, run by Stanford University at 2 sites in United States.
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 1 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula (time frame: 28 days from initial evaluation). 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 3 Dec 2021.