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

NCT05031845 | Completed

• 1 other identifier: 1689022
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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).

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Garfield Memorial Fund: collaborator

Study Sites (1)

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

Rockville, Maryland, 20852, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Douglas W Roblin, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientists

Study Record Dates

• First Submitted: August 28, 2021
• First Posted: September 2, 2021
• Study Start: March 8, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

US (1)