Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-03 @ 8:36 PM
Study NCT ID:
NCT04912895
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Detection of SARS-CoV-2 RNA in Coughed Droplets From Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'larry.anderson@emory.edu', 'phone': '404-727-1746', 'title': 'Larry Anderson, MD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected during the time period of specimen collection, up to 24 hours.', 'description': 'Only adverse events occurring during specimen collection were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of Detecting SARS-CoV-2 RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'PRIMARY', 'title': 'Specificity of Detecting SARS-CoV-2 RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of IFN Gamma Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.201', 'groupId': 'OG000', 'lowerLimit': '0.029', 'upperLimit': '0.342'}, {'value': '0.229', 'groupId': 'OG001', 'lowerLimit': '0.003', 'upperLimit': '2.222'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'picograms per milliliter (pg/mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of Interleukin (IL)-1 Beta Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.140', 'groupId': 'OG000', 'lowerLimit': '0.052', 'upperLimit': '0.566'}, {'value': '0.131', 'groupId': 'OG001', 'lowerLimit': '0.076', 'upperLimit': '64.522'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of IL-2 Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.157', 'groupId': 'OG000', 'lowerLimit': '0.071', 'upperLimit': '0.271'}, {'value': '0.219', 'groupId': 'OG001', 'lowerLimit': '0.117', 'upperLimit': '1.355'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of IL-4 Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.009', 'groupId': 'OG000', 'lowerLimit': '0.004', 'upperLimit': '0.041'}, {'value': '0.009', 'groupId': 'OG001', 'lowerLimit': '0.003', 'upperLimit': '0.104'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of IL-6 Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.081', 'groupId': 'OG000', 'lowerLimit': '0.020', 'upperLimit': '0.531'}, {'value': '0.076', 'groupId': 'OG001', 'lowerLimit': '0.001', 'upperLimit': '3.763'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of IL-8 Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.132', 'groupId': 'OG000', 'lowerLimit': '0.037', 'upperLimit': '9.984'}, {'value': '0.095', 'groupId': 'OG001', 'lowerLimit': '0.019', 'upperLimit': '639.432'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of IL-10 Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.028', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '0.113'}, {'value': '0.031', 'groupId': 'OG001', 'lowerLimit': '0.019', 'upperLimit': '0.634'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of IL-12p70 Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.088', 'groupId': 'OG000', 'lowerLimit': '0.040', 'upperLimit': '0.130'}, {'value': '0.082', 'groupId': 'OG001', 'lowerLimit': '0.033', 'upperLimit': '0.543'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of IL-13 Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.618', 'groupId': 'OG000', 'lowerLimit': '0.364', 'upperLimit': '0.708'}, {'value': '0.420', 'groupId': 'OG001', 'lowerLimit': '0.141', 'upperLimit': '7.549'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amount of Tumour Necrosis Factor (TNF) Alpha Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.026', 'groupId': 'OG000', 'lowerLimit': '0.004', 'upperLimit': '0.086'}, {'value': '0.017', 'groupId': 'OG001', 'lowerLimit': '0.001', 'upperLimit': '2.211'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who successfully provided a cough sample using the PneumoniaCheck.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Detection of Interleukin (IL)-1 Alpha', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Detection of Interferon (IFN) Alpha', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Detection of Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Detection of IL-17A', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Detection of Interferon Gamma-induced Protein 10 (IP-10) C-X-C Motif Chemokine Ligand 10 (CXCL10)', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Detection of Macrophage Inflammatory Protein-1 (MIP-1) Alpha', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Detection of Monocyte Chemoattractant Protein 1 (MCP-1)', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Detection of Surfactant A', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Detection of MIP-1 Beta', 'timeFrame': 'Up to Hour 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PneumoniaCheck Among SARS-CoV-2 Positive Participants', 'description': '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.'}, {'id': 'FG001', 'title': 'PneumoniaCheck Among Non-COVID-19 Acute Respiratory IllnessParticipants', 'description': '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.'}, {'id': 'FG002', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Unable to provide specimen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "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.", 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PneumoniaCheck Among SARSCoV-2 Positive Participants', 'description': '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.'}, {'id': 'BG001', 'title': 'PneumoniaCheck Among Healthy Controls', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Not collected', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2021-09-10', 'size': 339295, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-28T21:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2021-06-02', 'resultsFirstSubmitDate': '2023-08-01', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-29', 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Amount of IFN Gamma Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Amount of Interleukin (IL)-1 Beta Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Amount of IL-2 Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Amount of IL-4 Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Amount of IL-6 Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Amount of IL-8 Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Amount of IL-10 Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Amount of IL-12p70 Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Amount of IL-13 Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Amount of Tumour Necrosis Factor (TNF) Alpha Detected', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Detection of Interleukin (IL)-1 Alpha', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Detection of Interferon (IFN) Alpha', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Detection of Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Detection of IL-17A', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Detection of Interferon Gamma-induced Protein 10 (IP-10) C-X-C Motif Chemokine Ligand 10 (CXCL10)', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Detection of Macrophage Inflammatory Protein-1 (MIP-1) Alpha', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Detection of Monocyte Chemoattractant Protein 1 (MCP-1)', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Detection of Surfactant A', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Detection of MIP-1 Beta', 'timeFrame': 'Up to Hour 24', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Sensitivity of Detecting SARS-CoV-2 RNA', 'timeFrame': 'Up to Hour 24', 'description': '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.'}, {'measure': 'Specificity of Detecting SARS-CoV-2 RNA', 'timeFrame': 'Up to Hour 24', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being treated for an acute respiratory illness either as inpatients or outpatients at Emory University Hospital\n* English is a primary spoken language\n\nExclusion Criteria:\n\n* none\n\nInclusion Criteria for Healthy Volunteers:\n\n* Prior registration in an adult participant database and agreed to be contacted for future studies\n* English is a primary spoken language'}, 'identificationModule': {'nctId': 'NCT04912895', 'briefTitle': 'Detection of SARS-CoV-2 RNA in Coughed Droplets From Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Detection of SARS-CoV-2 RNA and Biomarkers in Coughed Droplets From Patients With COVID-19 and Controls', 'orgStudyIdInfo': {'id': 'STUDY00000863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SARS-CoV-2 Positive', 'description': 'Participants who test positive for SARS-CoV-2 with the Polymerase Chain Reaction (PCR) test.', 'interventionNames': ['Device: PneumoniaCheck']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-COVID-19 Acute Respiratory Illness', 'description': 'Participants who have an acute respiratory illness other than SARS-CoV-2 infection.', 'interventionNames': ['Device: PneumoniaCheck']}, {'type': 'OTHER', 'label': 'Healthy Controls', 'description': 'Participants without any acute respiratory illness.', 'interventionNames': ['Device: PneumoniaCheck']}], 'interventions': [{'name': 'PneumoniaCheck', 'type': 'DEVICE', 'description': 'Participants are asked to do 5 sets of 10 coughs, with at least 15 minutes between sets, into the PneumoniaCheck device.', 'armGroupLabels': ['Healthy Controls', 'Non-COVID-19 Acute Respiratory Illness', 'SARS-CoV-2 Positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory Children's Center", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wesley Woods Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Larry Anderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available for sharing following the publication of manuscripts related to the primary aims of this study.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Georgia Tech Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Larry J. Anderson', 'investigatorAffiliation': 'Emory University'}}}}