Covid19NCT04912895
Detection of SARS-CoV-2 RNA in Coughed Droplets From Patients With COVID-19
A study testing PneumoniaCheck in people with Covid19, run by Emory University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- PneumoniaCheck
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Apr 2021to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being treated for an acute respiratory illness either as inpatients or outpatients at Emory University Hospital
- English is a primary spoken language
- Prior registration in an adult participant database and agreed to be contacted for future studies
- English is a primary spoken language
Who cannot join
- none
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory Children's Center
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
Wesley Woods Center
Atlanta, Georgia, 30329
About this study
Official title: Detection of SARS-CoV-2 RNA and Biomarkers in Coughed Droplets From Patients With COVID-19 and Controls
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- PneumoniaCheck
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumoniaCheckDevice
Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Positive | Experimental | Participants who test positive for SARS-CoV-2 with the Polymerase Chain Reaction (PCR) test. Receives: Device: PneumoniaCheck |
| Non-COVID-19 Acute Respiratory Illness | Active comparator | Participants who have an acute respiratory illness other than SARS-CoV-2 infection. Receives: Device: PneumoniaCheck |
| Healthy Controls | Other | Participants without any acute respiratory illness. Receives: Device: PneumoniaCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start14 Apr 2021
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Tech Foundation
- Responsible party
- Principal investigator, Larry J. Anderson, Emory University
- Investigators
- Larry Anderson, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912895
- Sponsor's protocol ID
- STUDY00000863
- Status last verified
- Aug 2023
- First submitted
- 2 Jun 2021
- Last updated
- 7 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of SARS-CoV-2 RNA and Biomarkers in Coughed Droplets From Patients With COVID-19 and Controls
- ClinicalTrials.gov ID
- NCT04912895
- Acronym / sponsor ID
- STUDY00000863
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Tech Foundation
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Posted 7 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Positive | Experimental | Device: PneumoniaCheckParticipants who test positive for SARS-CoV-2 with the Polymerase Chain Reaction (PCR) test. |
| Non-COVID-19 Acute Respiratory Illness | Active comparator | Device: PneumoniaCheckParticipants who have an acute respiratory illness other than SARS-CoV-2 infection. |
| Healthy Controls | Other | Device: PneumoniaCheckParticipants without any acute respiratory illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being treated for an acute respiratory illness either as inpatients or outpatients at Emory University Hospital
- English is a primary spoken language
- Prior registration in an adult participant database and agreed to be contacted for future studies
- English is a primary spoken language
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PneumoniaCheckParticipants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device. | Device | Healthy Controls, Non-COVID-19 Acute Respiratory Illness, SARS-CoV-2 Positive |
Primary outcome
Sensitivity of Detecting SARS-CoV-2 RNA
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Anderson, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PneumoniaCheck in people with Covid19, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Detecting SARS-CoV-2 RNA (time frame: Up to Hour 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.