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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912895
• Other study ID #: STUDY00000863
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: August 5, 2022

Study information

• Verified date: August 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Device:
• PneumoniaCheck
Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.

Locations

Country	Name	City	State
United States	Emory Children's Center	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Wesley Woods Center	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Georgia Tech Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amount of IFN Gamma Detected	The researchers detected biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IFN gamma, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Amount of Interleukin (IL)-1 Beta Detected	The researchers detected biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-1 beta, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Amount of IL-2 Detected	The researchers detected biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-1 beta, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Amount of IL-4 Detected	The researchers detected biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-4, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Amount of IL-6 Detected	The researchers detected biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-6, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Amount of IL-8 Detected	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-8, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Amount of IL-10 Detected	The researchers detected biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-10, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Amount of IL-12p70 Detected	The researchers detected biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-12p70, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Amount of IL-13 Detected	The researchers detected biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-13, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Amount of Tumour Necrosis Factor (TNF) Alpha Detected	The researchers detected biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including TNF alpha, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Detection of Interleukin (IL)-1 Alpha	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-1 alpha, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Detection of Interferon (IFN) Alpha	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IFN alpha, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Detection of Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including GM-CSF, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Detection of IL-17A	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory cytokines, including IL-17A, in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Detection of Interferon Gamma-induced Protein 10 (IP-10) C-X-C Motif Chemokine Ligand 10 (CXCL10)	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory chemokines, including IP-10, also known as C-X-C motif chemokine ligand 10 (CXCL10), in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Detection of Macrophage Inflammatory Protein-1 (MIP-1) Alpha	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory chemokines, including MIP-1 alpha, also known as C-C motif chemokine ligand 3 (CCL3), in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Detection of Monocyte Chemoattractant Protein 1 (MCP-1)	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory chemokines, including MCP-1, also known as C-C motif chemokine ligand 2 (CCL2), in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Detection of Surfactant A	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting surfactant A chemokines in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Other	Detection of MIP-1 Beta	The researchers will detect biomarkers of inflammation in coughed specimens from patient with COVID-19 hypothesizing that biomarkers of inflammation from the lung will indicate disease activity, informing pathogenesis of COVID-19 disease. The value of detecting inflammatory chemokines, including MIP-1 beta, also known as C-C motif chemokine ligand 4 (CCL4), in cough-generated droplets with PneumoniaCheck from COVID-19 patients will be evaluated.	Up to Hour 24
Primary	Sensitivity of Detecting SARS-CoV-2 RNA	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.	Up to Hour 24
Primary	Specificity of Detecting SARS-CoV-2 RNA	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.	Up to Hour 24