Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320511
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Girish B. Nair, MD, William Beaumont Hospitals

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 25 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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. Informed consent
  3. A confirmed diagnosis of SARS-CoV-2 with mild to moderate disease defined as oxygen > 90% on room air on or supplemental oxygen not more than 6L
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320511


Contacts
Layout table for location contacts
Contact: Joanne Gondert, RN, BSN 248-898-0343 joanne.gondert@beaumont.org

Locations
Layout table for location information
United States, Michigan
Beaumont Health Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Joanne Gondert, RN, BSN    248-898-0343    joanne.gondert@beaumont.org   
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Layout table for investigator information
Principal Investigator: Girish B Nair, MD William Beaumont Hospitals
Layout table for additonal 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    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases