Clinical trial NCT05031845: Low-Dose Chest CT (LDCT) COVID-19 Study
Official title: Identification of Potentially Long-term Pulmonary Complications of COVID-19: A Pilot Study of Low-Dose Chest CT (LDCT) Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Garfield Memorial Fund
First posted: 2021-09-02
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline
measure: LDCT Abstract Form
timeFrame: Baseline
measure: Change from Baseline St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 3 to 6 months after the initial LDCT
measure: Change from Baseline LDCT Abstract Form
timeFrame: 3 to 6 months after the initial LDCT
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Research Institute
state: Maryland
Study officials:
affiliation: Kaiser Permanente
name: Douglas W Roblin, PhD
role: PRINCIPAL_INVESTIGATOR
References: