NCT04912895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 7, 2023

Completed
Last Updated

September 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

June 2, 2021

Results QC Date

August 1, 2023

Last Update Submit

August 29, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Other Outcomes (19)

  • Amount of IFN Gamma Detected

    Up to Hour 24

  • Amount of Interleukin (IL)-1 Beta Detected

    Up to Hour 24

  • Amount of IL-2 Detected

    Up to Hour 24

  • +16 more other outcomes

Study Arms (3)

SARS-CoV-2 Positive

EXPERIMENTAL

Participants who test positive for SARS-CoV-2 with the Polymerase Chain Reaction (PCR) test.

Device: PneumoniaCheck

Non-COVID-19 Acute Respiratory Illness

ACTIVE COMPARATOR

Participants who have an acute respiratory illness other than SARS-CoV-2 infection.

Device: PneumoniaCheck

Healthy Controls

OTHER

Participants without any acute respiratory illness.

Device: PneumoniaCheck

Interventions

PneumoniaCheckDEVICE

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

Healthy ControlsNon-COVID-19 Acute Respiratory IllnessSARS-CoV-2 Positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none
  • Prior registration in an adult participant database and agreed to be contacted for future studies
  • English is a primary spoken language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Wesley Woods Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Larry Anderson, MD
Organization
Emory University
larry.anderson@emory.edu
404-727-1746

Study Officials

  • Larry Anderson, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 3, 2021

Study Start

April 14, 2021

Primary Completion

August 5, 2022

Study Completion

August 5, 2022

Last Updated

September 7, 2023

Results First Posted

September 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Individual participant data collected during the trial will be made available for sharing, after deidentification, as consistent with Health Information Privacy and Portability Act (HIPPA) regulations.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available for sharing following the publication of manuscripts related to the primary aims of this study.
Access Criteria
Individual participant data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims stated in the approved proposal. Proposals should be directed to Dr. Larry Anderson.

Locations

US(4)