Covid19NCT05031845
Low-Dose Chest CT (LDCT) COVID-19 Study
An observational study of Covid19, run by Kaiser Permanente at 1 site in United States.
Trial summary
The goal of our proposed pilot study is to collect low dose CT (LDCT) findings from chest evaluations of a representative sample of 120 symptomatic Caucasian and African American, and Hispanic adults (45 each), stratified by presence of acute respiratory distress syndrome (ARDS) and COVID-19 positivity or negative PCR… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 30 Dec 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
- Adult, Older adult
Study population: Eligible participants must be ≥ 18 years of age, alive, and a KPMAS member primarily residing in the DCSM service area (Montgomery, Frederick or Prince George's counties), at the time of invitation and had COVID-19 related symptoms at the time of COVID-19 PCR testing.
Who may be able to join
- KPMAS members, primarily residing in the DCSM service area (Montgomery, Frederick or Prince George's counties),
- ≥ 18 years of age or older
- Have a recent PCR test with a positive or negative result, and/or evidence of ARDS and who were symptomatic for COVID-19 related symptoms at the time of the test.
Who cannot join
- Pregnant or intending to become pregnant in the next 1-3 months
- Cancer or other treatment involving radiation therapy at any time
- Terminally ill
- Non-English speaking
- Diminished cognitive capacity
- Developmental disabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Research Institute
Rockville, Maryland, 20852
About this study
Official title: Identification of Potentially Long-term Pulmonary Complications of COVID-19: A Pilot Study of Low-Dose Chest CT (LDCT) Imaging
The goal of our proposed pilot study is to collect low dose CT (LDCT) findings from chest evaluations of a representative sample of 120 symptomatic Caucasian and African American, and Hispanic adults (45 each), stratified by presence of acute respiratory distress syndrome (ARDS) and COVID-19 positivity or negative PCR screening results. These data will provide us with preliminary data on the type and extent of alveolar remodeling by race and by severity of recent infectious respiratory disease. Findings from our study would will help us to determine if a larger multi-site research application to NHLBI or a similar funding agency might be possible and provide critical preliminary data on variation in LDCT findings by COVID-19 attributable respiratory health, race, and other risk factors (e.g., smoking history, comorbidities, and socioeconomic status).
Read the detailed description
This is a prospective data collection study of random samples of Caucasian and African American, and Hispanic adults, who are symptomatic and recently tested with a nasal or nasopharyngeal swab test (PCR test) and by test positivity and/or evidence of recent acute respiratory distress.
Our study has 2 objectives: 1) demonstrate the feasibility of using KP electronic health records (EHR) and associated computerized data resources to identify and recruit representative samples of Caucasian and African American, and Hispanic adults with varying likelihoods of lung remodeling, and 2) identify the implementation opportunities and challenges associated with recruitment for and collection of primary LDCT findings in a representative sample of adults from a diverse urban population.
The specific aims of our study are:
Aim 1: Implement a sampling and recruitment protocol to collect representative samples of Caucasian and African American, and Hispanic adults by clinical history attributable to ARDS (e.g., hospitalization for ARDS, not hospitalized by positive/negative for COVID-19) and presenting with symptoms typical of COVID-19 (i.e. fever, cough, shortness of breath, nausea/vomiting) Aim 2: Collect LDCT findings and self-reported respiratory health at the time of LDCT from this sample.
Aim 3: Link the LDCT findings to other electronic health record (EHR) data to assess face validity of findings through associations with race, other patient demographics, and clinical risk factors associated with self-reported respiratory health.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive, Hospitalized with ARDS | 1. Patients with chest imaging at the time of the first COVID-positive PCR test will have their first LDCT within 3 to 4 months after COVID 19 diagnosis. A second LDCT between 3 to 6 months after the initial LDCT. 2. Patients without chest imaging at the time of the first COVID-positive PCR test or with a negative COVID PCR test will have their first LDCT within 2 weeks to 1 month after their recovery from COVID 19, or testing. A second LDCT may be performed between 3 to 6 months after the initial LDCT. | |
| COVID-19 positive, not hospitalized with ARDS | 1. Patients with chest imaging at the time of the first COVID-positive PCR test will have their first LDCT within 3 to 4 months after COVID 19 diagnosis. A second LDCT between 3 to 6 months after the initial LDCT. 2. Patients without chest imaging at the time of the first COVID-positive PCR test or with a negative COVID PCR test will have their first LDCT within 2 weeks to 1 month after their recovery from COVID 19, or testing. A second LDCT may be performed between 3 to 6 months after the initial LDCT. | |
| COVID-19 negative, not hospitalized with ARDS | 1. Patients with chest imaging at the time of the first COVID-positive PCR test will have their first LDCT within 3 to 4 months after COVID 19 diagnosis. A second LDCT between 3 to 6 months after the initial LDCT. 2. Patients without chest imaging at the time of the first COVID-positive PCR test or with a negative COVID PCR test will have their first LDCT within 2 weeks to 1 month after their recovery from COVID 19, or testing. A second LDCT may be performed between 3 to 6 months after the initial LDCT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is a disease specific quality of life assessment tool validated in both COPD and asthma 12-14. The questionnaire consists of 50 items divided into three parts measuring symptoms, activity limitation and social and emotional impact of disease. The questionnaire will be used to examine respiratory health.
Measured: Baseline
LDCT Abstract Form
LDCT findings will be classified on the presence/absence of ground glass opacities, consolidation, septal thickening, and crazy paving. In addition, the findings will be classified using two quantitative measures: number of lobes involved and percentage of involvement per lobe.
Measured: Baseline
Change from Baseline St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is a disease specific quality of life assessment tool validated in both COPD and asthma 12-14. The questionnaire consists of 50 items divided into three parts measuring symptoms, activity limitation and social and emotional impact of disease. The questionnaire will be used to examine respiratory health.
Measured: 3 to 6 months after the initial LDCT
Change from Baseline LDCT Abstract Form
LDCT findings will be classified on the presence/absence of ground glass opacities, consolidation, septal thickening, and crazy paving. In addition, the findings will be classified using two quantitative measures: number of lobes involved and percentage of involvement per lobe.
Measured: 3 to 6 months after the initial LDCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start8 Mar 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Garfield Memorial Fund
- Responsible party
- Principal investigator, Douglas W. Roblin, Kaiser Permanente
- Investigators
- Douglas W Roblin, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031845
- Sponsor's protocol ID
- 1689022
- Status last verified
- May 2022
- First submitted
- 28 Aug 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Potentially Long-term Pulmonary Complications of COVID-19: A Pilot Study of Low-Dose Chest CT (LDCT) Imaging
- ClinicalTrials.gov ID
- NCT05031845
- Acronym / sponsor ID
- 1689022
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Garfield Memorial Fund
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 2 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.
The goal of our proposed pilot study is to collect low dose CT (LDCT) findings from chest evaluations of a representative sample of 120 symptomatic Caucasian and African American, and Hispanic adults (45 each), stratified by presence of acute respiratory distress syndrome (ARDS) and COVID-19 positivity or negative PCR screening results. These data will provide us with preliminary data on the type and extent of alveolar remodeling by race and by severity of recent infectious respiratory disease. Findings from our study would will help us to determine if a larger multi-site research application to NHLBI or a similar funding agency might be possible and provide critical preliminary data on variation in LDCT findings by COVID-19 attributable respiratory health, race, and other risk factors (e.g., smoking history, comorbidities, and socioeconomic status).
Detailed description
This is a prospective data collection study of random samples of Caucasian and African American, and Hispanic adults, who are symptomatic and recently tested with a nasal or nasopharyngeal swab test (PCR test) and by test positivity and/or evidence of recent acute respiratory distress.
Our study has 2 objectives: 1) demonstrate the feasibility of using KP electronic health records (EHR) and associated computerized data resources to identify and recruit representative samples of Caucasian and African American, and Hispanic adults with varying likelihoods of lung remodeling, and 2) identify the implementation opportunities and challenges associated with recruitment for and collection of primary LDCT findings in a representative sample of adults from a diverse urban population.
The specific aims of our study are:
Aim 1: Implement a sampling and recruitment protocol to collect representative samples of Caucasian and African American, and Hispanic adults by clinical history attributable to ARDS (e.g., hospitalization for ARDS, not hospitalized by positive/negative for COVID-19) and presenting with symptoms typical of COVID-19 (i.e. fever, cough, shortness of breath, nausea/vomiting) Aim 2: Collect LDCT findings and self-reported respiratory health at the time of LDCT from this sample.
Aim 3: Link the LDCT findings to other electronic health record (EHR) data to assess face validity of findings through associations with race, other patient demographics, and clinical risk factors associated with self-reported respiratory health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive, Hospitalized with ARDS | – | –1. Patients with chest imaging at the time of the first COVID-positive PCR test will have their first LDCT within 3 to 4 months after COVID 19 diagnosis. A second LDCT between 3 to 6 months after the initial LDCT. 2. Patients without chest imaging at the time of the first COVID-positive PCR test or with a negative COVID PCR test will have their first LDCT within 2 weeks to 1 month after their recovery from COVID 19, or testing. A second LDCT may be performed between 3 to 6 months after the initial LDCT. |
| COVID-19 positive, not hospitalized with ARDS | – | –1. Patients with chest imaging at the time of the first COVID-positive PCR test will have their first LDCT within 3 to 4 months after COVID 19 diagnosis. A second LDCT between 3 to 6 months after the initial LDCT. 2. Patients without chest imaging at the time of the first COVID-positive PCR test or with a negative COVID PCR test will have their first LDCT within 2 weeks to 1 month after their recovery from COVID 19, or testing. A second LDCT may be performed between 3 to 6 months after the initial LDCT. |
| COVID-19 negative, not hospitalized with ARDS | – | –1. Patients with chest imaging at the time of the first COVID-positive PCR test will have their first LDCT within 3 to 4 months after COVID 19 diagnosis. A second LDCT between 3 to 6 months after the initial LDCT. 2. Patients without chest imaging at the time of the first COVID-positive PCR test or with a negative COVID PCR test will have their first LDCT within 2 weeks to 1 month after their recovery from COVID 19, or testing. A second LDCT may be performed between 3 to 6 months after the initial LDCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible participants must be ≥ 18 years of age, alive, and a KPMAS member primarily residing in the DCSM service area (Montgomery, Frederick or Prince George's counties), at the time of invitation and had COVID-19 related symptoms at the time of COVID-19 PCR testing.
Key inclusion criteria (3 listed)
- KPMAS members, primarily residing in the DCSM service area (Montgomery, Frederick or Prince George's counties),
- ≥ 18 years of age or older
- Have a recent PCR test with a positive or negative result, and/or evidence of ARDS and who were symptomatic for COVID-19 related symptoms at the time of the test.
Key exclusion criteria (6 listed)
- Pregnant or intending to become pregnant in the next 1-3 months
- Cancer or other treatment involving radiation therapy at any time
- Terminally ill
- Non-English speaking
- Diminished cognitive capacity
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
St. George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline
The SGRQ is a disease specific quality of life assessment tool validated in both COPD and asthma 12-14. The questionnaire consists of 50 items divided into three parts measuring symptoms, activity limitation and social and emotional impact of disease. The questionnaire will be used to examine respiratory health.
LDCT Abstract Form
Time frame: Baseline
LDCT findings will be classified on the presence/absence of ground glass opacities, consolidation, septal thickening, and crazy paving. In addition, the findings will be classified using two quantitative measures: number of lobes involved and percentage of involvement per lobe.
Change from Baseline St. George's Respiratory Questionnaire (SGRQ)
Time frame: 3 to 6 months after the initial LDCT
The SGRQ is a disease specific quality of life assessment tool validated in both COPD and asthma 12-14. The questionnaire consists of 50 items divided into three parts measuring symptoms, activity limitation and social and emotional impact of disease. The questionnaire will be used to examine respiratory health.
Change from Baseline LDCT Abstract Form
Time frame: 3 to 6 months after the initial LDCT
LDCT findings will be classified on the presence/absence of ground glass opacities, consolidation, septal thickening, and crazy paving. In addition, the findings will be classified using two quantitative measures: number of lobes involved and percentage of involvement per lobe.
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 17 May 2022.
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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.
Douglas W Roblin, PhD principal investigator
Kaiser Permanente
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, run by Kaiser Permanente at 1 site 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 6 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 17 May 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 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?
St. George's Respiratory Questionnaire (SGRQ) (time frame: Baseline). The study lists 4 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 17 May 2022.