Low-Dose Chest CT (LDCT) COVID-19 Study

NCT ID: NCT05031845

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2021-12-30

Brief 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 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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Garfield Memorial Fund

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Douglas W. Roblin

Senior Research Scientists

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas W Roblin, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Research Institute

Rockville, Maryland, United States

Countries

United States

Other Identifiers

1689022

Identifier Type: -

Identifier Source: org_study_id