Clinical trial NCT04912895: Detection of SARS-CoV-2 RNA in Coughed Droplets From Patients With COVID-19
Official title: Detection of SARS-CoV-2 RNA and Biomarkers in Coughed Droplets From Patients With COVID-19 and Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Tech Foundation
First posted: 2021-06-03
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Detecting SARS-CoV-2 RNA
timeFrame: Up to Hour 24
measure: Specificity of Detecting SARS-CoV-2 RNA
timeFrame: Up to Hour 24
Secondary outcomes:
Other outcomes:
measure: Amount of IFN Gamma Detected
timeFrame: Up to Hour 24
measure: Amount of Interleukin (IL)-1 Beta Detected
timeFrame: Up to Hour 24
measure: Amount of IL-2 Detected
timeFrame: Up to Hour 24
measure: Amount of IL-4 Detected
timeFrame: Up to Hour 24
measure: Amount of IL-6 Detected
timeFrame: Up to Hour 24
measure: Amount of IL-8 Detected
timeFrame: Up to Hour 24
measure: Amount of IL-10 Detected
timeFrame: Up to Hour 24
measure: Amount of IL-12p70 Detected
timeFrame: Up to Hour 24
measure: Amount of IL-13 Detected
timeFrame: Up to Hour 24
measure: Amount of Tumour Necrosis Factor (TNF) Alpha Detected
timeFrame: Up to Hour 24
measure: Detection of Interleukin (IL)-1 Alpha
timeFrame: Up to Hour 24
measure: Detection of Interferon (IFN) Alpha
timeFrame: Up to Hour 24
measure: Detection of Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
timeFrame: Up to Hour 24
measure: Detection of IL-17A
timeFrame: Up to Hour 24
measure: Detection of Interferon Gamma-induced Protein 10 (IP-10) C-X-C Motif Chemokine Ligand 10 (CXCL10)
timeFrame: Up to Hour 24
measure: Detection of Macrophage Inflammatory Protein-1 (MIP-1) Alpha
timeFrame: Up to Hour 24
measure: Detection of Monocyte Chemoattractant Protein 1 (MCP-1)
timeFrame: Up to Hour 24
measure: Detection of Surfactant A
timeFrame: Up to Hour 24
measure: Detection of MIP-1 Beta
timeFrame: Up to Hour 24
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Wesley Woods Center
state: Georgia
Study officials:
affiliation: Emory University
name: Larry Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References: