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
NCT number | NCT05031845 |
Other study ID # | 1689022 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 8, 2021 |
Est. completion date | December 30, 2021 |
Verified date | May 2022 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 121 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Research Institute | Rockville | Maryland |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Garfield Memorial Fund |
United States,
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 |
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