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

Covid19 Clinical Trial

Official title:

Identification of Potentially Long-term Pulmonary Complications of COVID-19: A Pilot Study of Low-Dose Chest CT (LDCT) Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031845
• Other study ID #: 1689022
• Status: Completed
• Start date: March 8, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
United States	Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Research Institute	Rockville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Garfield Memorial Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	3 to 6 months after the initial LDCT
Primary	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.	3 to 6 months after the initial LDCT