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

Study Description

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.

Condition or disease	Intervention/treatment
SARS-COV2; Severe Acute Respiratory Syndrome; COVID-19	Device: CT-V

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 Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COVID CT, Beaumont Quantitative Lung Function Imaging to Characterize Patients With SARS-COV 2
• Actual Study Start Date: June 24, 2020
• Actual Primary Completion Date: May 14, 2021
• Actual Study Completion Date: May 14, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Patients with SARS-COV 2; Patients with SARS-COV 2 undergoing CT-V	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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

SARS-COV 2 positive patients who present to Beaumont-Royal Oak Emergency Center

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

Contacts and Locations

Locations

United States, Michigan

Beaumont Health

Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

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

More Information

• Responsible Party: Girish B. Nair, MD, Pulmonary Medicine Physician, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT04320511
• Other Study ID Numbers: 2020-087
• First Posted: March 25, 2020
• Last Update Posted: January 5, 2022
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Girish B. Nair, MD, William Beaumont Hospitals:

Quantitative CT Lung Function Imaging; Pulmonary Blood Mass

Additional relevant MeSH terms:

Severe Acute Respiratory Syndrome; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases