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

NCT04320511 | Terminated FDA Device

• 1 other identifier: 2020-087
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Quantitative CT Lung Function Imaging; Pulmonary Blood Mass

Outcome Measures

Primary Outcomes (1)

• Predictive association between CT-V, PBM score and disease progression

  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.

  30 days

Study Arms (1)

Patients with SARS-COV 2

Patients with SARS-COV 2 undergoing CT-V

Device: CT-V

Interventions

CT-V DEVICE

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

Patients with SARS-COV 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Girish B Nair, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary Medicine Physician

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: June 24, 2020
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)