Detection of SARS-CoV-2 RNA in Coughed Droplets From Patients With COVID-19

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Device: PneumoniaCheck

• Registration Number: NCT04912895
• Lead Sponsor: Emory University

Brief Summary

The purpose of this study is to learn how to better detect infection and understand how severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes lung disease and is spread. The novel device called PneumoniaCheck is a safe way to collect material from the lung from coughs. Study participants will collect cough specimens over a 24 hour period.

Detailed Description

A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was detected in association with cases of severe respiratory illness and pneumonia (COVID-19) in Wuhan City, Hubei Province, China in December 2019. The virus subsequently spread widely throughout China and globally. Addressing this unprecedented global pandemic is requiring all available tools to diagnose infection, manage ill patients, understand disease pathogenesis and virus transmission to guide efforts to decrease transmission and rapidly develop anti-viral drugs and vaccines. The researchers of this study propose to use the PneumoniaCheck™, a device developed collaboratively by investigators at the Georgia Institute of Technology (GA Tech) and the Centers for Disease Control and Prevention (CDC), to help address these issues. This device, non-invasively, captures coughed droplets onto a filter with minimal contamination from upper airway secretions. In preliminary studies in cystic fibrosis, mycobacterium tuberculosis (TB) patients and control patients, the researchers detected bacterial DNA by PCR, inflammatory cytokines and chemokines by multiplex Luminex assays, surfactant by enzyme immunoassay (EIA), and amylase by enzymatic assay. These data show that this device can provide high quality specimens from the lung with minimal risk to the patient and healthcare provider and much lower risk than invasive procedures such as bronchioloalveolar lavage. In addition, with this device, the researchers can acquire specimens from patients who do not have a productive cough (dry cough), a commonly reported symptom for COVID-19, and specimens with minimal upper respiratory contamination unlike a sputum specimen. Thus, this device can provide lung secretion specimens to improve detection of SARS-CoV-2 RNA (lung specimens are better for detecting virus than upper respiratory tract specimens) and detect inflammatory and other biomarkers to explore pathogenesis of disease, identify inflammatory processes that might be amenable to intervention, and identify biomarkers of disease severity for patient management and evaluation of vaccines and anti-viral drugs. The goal of this study is to determine how PneumoniaCheck™ can help diagnose, manage, and understand pathogenesis of disease and transmission risk of COVID-19.

Study Timeline

• Study Start: 2021-04-14
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-03
• Primary Completion: 2022-08-05
• Study Completion: 2022-08-05
• Status Verified: 2023-08
• Results First Submitted: 2023-08-01
• Results First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Results First Posted: 2023-09-07
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Being treated for an acute respiratory illness either as inpatients or outpatients at Emory University Hospital
• English is a primary spoken language

Exclusion Criteria

• none

Inclusion Criteria for Healthy Volunteers:

• Prior registration in an adult participant database and agreed to be contacted for future studies
• English is a primary spoken language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-COVID-19 Acute Respiratory Illness	PneumoniaCheck	Participants who have an acute respiratory illness other than SARS-CoV-2 infection.
Healthy Controls	PneumoniaCheck	Participants without any acute respiratory illness.
SARS-CoV-2 Positive	PneumoniaCheck	Participants who test positive for SARS-CoV-2 with the Polymerase Chain Reaction (PCR) test.

Primary Outcome Measures

Name	Time	Method
Sensitivity of Detecting SARS-CoV-2 RNA	Up to Hour 24	The number of correct identification of participants with SARS-CoV-2 infection (true positives) detected by RNA in cough-generated droplets captured with the PneumoniaCheck.
Specificity of Detecting SARS-CoV-2 RNA	Up to Hour 24	The number of correct identification of participants without SARS-CoV-2 infection (true negatives) detected by RNA in cough-generated droplets captured with the PneumoniaCheck.

Trial Locations

Locations (4)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory Children's Center; 🇺🇸 Atlanta, Georgia, United States

Wesley Woods Center; 🇺🇸 Atlanta, Georgia, United States