Predicting Outcomes for Covid-19 Using Sonography

NCT04384055 | Completed

• 1 other identifier: IRB-55621
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 2

Brief Summary

This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify Covid-19 pneumonia or patients at risk for deterioration early in the disease course.

Conditions

COVID-19; Pneumonia, Viral

Outcome Measures

Primary Outcomes (1)

• Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula

  Composite primary outcome of death, ICU admission, mechanical ventilation, or use of high-flow nasal cannula (categorical)

  28 days from initial evaluation

Secondary Outcomes (5)

• Number of Patients Requiring Mechanical Ventilation

  28 days from initial evaluation

• Number of Patients Requiring Supplemental Oxygen Usage

  28 days from initial evaluation

• Duration of Supplemental Oxygen Usage

  28 days from initial evaluation

• Length of Stay

  28 days from initial evaluation

• Characterization of Ultrasound Findings

  28 days from initial evaluation

Study Arms (2)

Covid-19 Positive Patients

This group includes individuals who were diagnosed with Covid-19 based on reverse transcriptase polymerase chain reaction (RT-PCR) of the nasopharynx

Diagnostic Test: Lung Ultrasound

Covid-19 Negative Patients

This group includes individuals who did NOT have a positive test for Covid-19 based on reverse transcriptase polymerase chain reaction (RT-PCR) of the nasopharynx.

Diagnostic Test: Lung Ultrasound

Interventions

Lung Ultrasound DIAGNOSTIC_TEST

Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.

Covid-19 Negative Patients; Covid-19 Positive Patients

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

This population will include all persons under investigation (PUIs) for covid-19 presenting to the Stanford emergency department.

You may qualify if:

• Any adult (18 or more years of age) presenting to the emergency department with symptoms suspicious for Covid-19
• This individual underwent evaluation for Covid-19 via a nasopharyngeal RT-PCR
• This individual received a lung ultrasound by the study authors within 28 days from initial evaluation

You may not qualify if:

• Any individual who did not receive a lung ultrasound within 28 days from initial evaluation for covid-19 related illness

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

University of California San Francisco

San Francisco, California, 94117, United States

Location

Stanford University

Stanford, California, 95401, United States

Location

MeSH Terms

Conditions

COVID-19; Pneumonia, Viral

Condition Hierarchy (Ancestors)

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

Study Officials

• Andre D Kumar, MD, MEd

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sally Graglia, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 12, 2020
• Study Start: March 21, 2020
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)