Beaumont Quantitative Lung Function Imaging to Characterize Patients With SARS-COV 2

• ClinicalTrials.gov Identifier: NCT04320511
• Recruitment Status: Terminated
• First Posted: March 25, 2020
• Last Update Posted: January 5, 2022
• Sponsor: William Beaumont Hospitals
• Information provided by (Responsible Party): Girish B. Nair, MD, William Beaumont Hospitals

Tracking Information

• First Submitted Date: March 23, 2020
• First Posted Date: March 25, 2020
• Last Update Posted Date: January 5, 2022
• Actual Study Start Date: June 24, 2020
• Actual Primary Completion Date: May 14, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 23, 2020)

Predictive association between CT-V, PBM score and disease progression [ Time Frame: 30 days ]

Disease progression will be characterized as requiring mechanical ventilator support, non-invasive positive pressure ventilation, high flow nasal cannula or mortality within 30 days.CT-V and PBM scores will be calculated at a voxel level from inhalation-exhalation CT scan. Several CT-V pulmonary function metrics, including the volume of identified "cold spots" (areas with decreased ventilation and perfusion), total ventilation and perfusion and radiographic fibrosis score will be calculated to assess regional ventilation/perfusion and compared to disease progression. The number of participants with correlation between these factors will be reported.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Beaumont Quantitative Lung Function Imaging to Characterize Patients With SARS-COV 2
• Official Title: COVID CT, Beaumont Quantitative Lung Function Imaging to Characterize Patients With SARS-COV 2
• Brief Summary: The goal of this study is to evaluate if CT (Computerized Tomography) can effectively and accurately predict disease progression in patients with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). You may be eligible if you have been diagnosed with SARS-CoV-2, are an inpatient at Beaumont Hospital-Royal Oak and meet eligibility criteria. After consent and determination of eligibility, enrolled patients will have a CT scanning session. After the CT scan, patients are followed for 30 days by reviewing their medical records and by phone after discharge from hospital.
• Detailed Description: Beaumont Quantitative CT lung function imaging (BQLFI) uses mathematical modeling to determine regional differences in ventilation (CT-V) and pulmonary blood mass (PBM) from a pair of inspiration-expiration CT scans or time-resolved four-dimensional (4D) CT scans. CT-V and PBM images provide surrogates for pulmonary ventilation and perfusion, respectively, in the form of detailed functional maps. CT-V and PBM therefore allow us to distinguish healthy from abnormal lung. Moreover, the technique generalizes to recover lung compliance imaging (LCI) when the CT is acquired at different pressure settings, in order to characterize lung stiffness. PBM and CT-V can detect parenchymal lung function changes at a voxel level and can be used to 1) assess disease progression in SARS-CoV-2, 2) detect treatment effects, and 3) identify early changes in high-risk patients prior to their development of disease. BQLFI affords the opportunity to provide imaging biomarkers that enable the early diagnosis of lung injury, which in turn cause impairment in gas exchange at the level of alveolar capillary interface. Currently, there are no available imaging biomarkers to predict patients at risk of progression or identify those at risk of developing severe disease with SARS-CoV-2. Our proposed study will validate a novel methodology, based on state-of-the-art CT-V and PBM imaging that can accurately measure regional ventilation and perfusion, as a means for improving surveillance, diagnosis, and prognostication of patients with SARS-CoV-2. This is a prospective, pilot study of 25 adult patients with SARS-CoV-2, who have mild to moderate disease, defined as positive PCR screen and not requiring invasive mechanical ventilator support or noninvasive ventilation or high flow nasal cannula. Participants will provide informed consent and eligibility will be confirmed. Demographics and medical history will be obtained. Participants will undergo one inspiration-expiration CT. Outcomes and adverse events will be assessed over 30 day using chart review or phone interview.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: SARS-COV 2 positive patients who present to Beaumont-Royal Oak Emergency Center

Condition

• SARS-COV2
• Severe Acute Respiratory Syndrome
• COVID-19

Intervention

Device: CT-V

CT-V is an image processing-based modality that recovers changes in local tissue volumes, induced by respiratory motion, from an inspiration-expiration CT (IE-CT) scan or a standard non-contrast 4D CT scan

Study Groups/Cohorts

Patients with SARS-COV 2

Patients with SARS-COV 2 undergoing CT-V

Intervention: Device: CT-V

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 14, 2021): 15
• Original Estimated Enrollment (submitted: March 23, 2020): 25
• Actual Study Completion Date: May 14, 2021
• Actual Primary Completion Date: May 14, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

1. Adults >18 years of age
2. Written Informed consent
3. A confirmed diagnosis of SARS-CoV-2 with mild to moderate disease, on room air or supplemental oxygen not more than 12L
4. Concomitant medications for the treatment are allowed

Exclusion criteria:

1. Patients <18 years
2. Pregnant females
3. Invasive ventilator support or non-invasive ventilator support including high flow nasal cannula
4. COPD or Congestive Heart Failure patients requiring home oxygen
5. History of lung cancer and radiation to lung or had prior radiation to the chest

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04320511
• Other Study ID Numbers: 2020-087
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Girish B. Nair, MD, William Beaumont Hospitals
• Original Responsible Party: Same as current
• Current Study Sponsor: William Beaumont Hospitals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Girish B Nair, MD; William Beaumont Hospitals

• PRS Account: William Beaumont Hospitals
• Verification Date: August 2021