Trial Outcomes & Findings for Detection of SARS-CoV-2 RNA in Coughed Droplets From Patients With COVID-19 (NCT NCT04912895)

NCT ID: NCT04912895

Last Updated: 2023-09-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

Up to Hour 24

Results posted on

2023-09-07

Participant Flow

Participants were recruited from the Emory Children's Center, Emory University Hospital Midtown, Emory University Hospital, and the Wesley Woods Center in Atlanta, Georgia, USA. Participant enrollment began April 14, 2022 and all follow-up assessments were completed by August 5, 2022.

The study initially planned to recruit participants with non-coronavirus disease 2019 (COVID-19) respiratory illness, however, resources did not permit including this study arm.

Participant milestones

Participant milestones
Measure
PneumoniaCheck Among SARS-CoV-2 Positive Participants
Participants who test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with the polymerase chain reaction (PCR) test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Non-COVID-19 Acute Respiratory IllnessParticipants
Participants who have an acute respiratory illness other than SARS-CoV-2 infection use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Overall Study
STARTED
51
0
18
Overall Study
COMPLETED
49
0
18
Overall Study
NOT COMPLETED
2
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
PneumoniaCheck Among SARS-CoV-2 Positive Participants
Participants who test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with the polymerase chain reaction (PCR) test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Non-COVID-19 Acute Respiratory IllnessParticipants
Participants who have an acute respiratory illness other than SARS-CoV-2 infection use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Overall Study
Unable to provide specimen
2
0
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=51 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Total
n=69 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=51 Participants
0 Participants
n=18 Participants
0 Participants
n=69 Participants
Age, Categorical
Between 18 and 65 years
51 Participants
n=51 Participants
18 Participants
n=18 Participants
69 Participants
n=69 Participants
Age, Categorical
>=65 years
0 Participants
n=51 Participants
0 Participants
n=18 Participants
0 Participants
n=69 Participants
Sex/Gender, Customized
Female
27 Participants
n=51 Participants
0 Participants
n=18 Participants
27 Participants
n=69 Participants
Sex/Gender, Customized
Male
21 Participants
n=51 Participants
0 Participants
n=18 Participants
21 Participants
n=69 Participants
Sex/Gender, Customized
Not collected
3 Participants
n=51 Participants
18 Participants
n=18 Participants
21 Participants
n=69 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
51 Participants
n=51 Participants
18 Participants
n=18 Participants
69 Participants
n=69 Participants

PRIMARY outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Sensitivity of Detecting SARS-CoV-2 RNA
31 Participants
0 Participants

PRIMARY outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Specificity of Detecting SARS-CoV-2 RNA
10 Participants
18 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of IFN Gamma Detected
0.201 picograms per milliliter (pg/mL)
Interval 0.029 to 0.342
0.229 picograms per milliliter (pg/mL)
Interval 0.003 to 2.222

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of Interleukin (IL)-1 Beta Detected
0.140 pg/mL
Interval 0.052 to 0.566
0.131 pg/mL
Interval 0.076 to 64.522

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of IL-2 Detected
0.157 pg/mL
Interval 0.071 to 0.271
0.219 pg/mL
Interval 0.117 to 1.355

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of IL-4 Detected
0.009 pg/mL
Interval 0.004 to 0.041
0.009 pg/mL
Interval 0.003 to 0.104

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of IL-6 Detected
0.081 pg/mL
Interval 0.02 to 0.531
0.076 pg/mL
Interval 0.001 to 3.763

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of IL-8 Detected
0.132 pg/mL
Interval 0.037 to 9.984
0.095 pg/mL
Interval 0.019 to 639.432

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of IL-10 Detected
0.028 pg/mL
Interval 0.015 to 0.113
0.031 pg/mL
Interval 0.019 to 0.634

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of IL-12p70 Detected
0.088 pg/mL
Interval 0.04 to 0.13
0.082 pg/mL
Interval 0.033 to 0.543

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of IL-13 Detected
0.618 pg/mL
Interval 0.364 to 0.708
0.420 pg/mL
Interval 0.141 to 7.549

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

Population: This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.

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.

Outcome measures

Outcome measures
Measure
PneumoniaCheck Among SARSCoV-2 Positive Participants
n=49 Participants
Participants who test positive for SARS-CoV-2 with the PCR test use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
PneumoniaCheck Among Healthy Controls
n=18 Participants
Participants without any acute respiratory illness use the PneumoniaCheck device to collect material from the lung from coughs. Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.
Amount of Tumour Necrosis Factor (TNF) Alpha Detected
0.026 pg/mL
Interval 0.004 to 0.086
0.017 pg/mL
Interval 0.001 to 2.211

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Hour 24

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.

Outcome measures

Outcome data not reported

Adverse Events

PneumoniaCheck Among SARSCoV-2 Positive Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PneumoniaCheck Among Healthy Controls

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Larry Anderson, MD

Emory University

Phone: 404-727-1746

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place