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Clinical 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 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05031845
Study type Observational
Source Kaiser Permanente
Contact Douglas W Roblin, PhD
Phone 301-816-5971
Email [email protected]
Status Recruiting
Phase
Start date March 8, 2021
Completion date December 30, 2021

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