Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04698993
Status:
TERMINATED
Last Update Posted:
2021-07-20
First Post:
2021-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dräger COVID-19 Antigen Test Clinical Performance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'rainer.polzius@draeger.com', 'phone': '+498824514429', 'title': 'Dr Rainer Polzius', 'organization': 'Draegerwerk AG & Co. KGaA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test', 'otherNumAtRisk': 275, 'deathsNumAtRisk': 275, 'otherNumAffected': 0, 'seriousNumAtRisk': 275, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}], 'classes': [{'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '99.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Sensitivity (true positive rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \\>=10\\^6 RNA copies/ml for positive PCR results)', 'unitOfMeasure': 'percentage of true cases', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '8 symptomatic participants with low RNA copy number were excluded for the calculation of the primary endpoint As this endpoint only considers the sensitivity in symptomatic participants, no numbers are shown for the asymptomatic group'}, {'type': 'PRIMARY', 'title': 'Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Specificity (true negative rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \\>=10\\^6 RNA copies/ml for positive PCR results)', 'unitOfMeasure': 'percentage of true negative cases', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '8 symptomatic participants were excluded due to low RNA copy number As this endpoint only considers the specificity in symptomatic participants, no numbers are shown for the asymptomatic group'}, {'type': 'SECONDARY', 'title': 'Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}], 'classes': [{'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Description of relationship between cycle threshold value of the reference RT-PCR and Dräger test performance.\n\nPresented is the sensitivity(true positive rate) in the symptomatic group at a cycle threshold of \\<22', 'unitOfMeasure': 'percentage of true positive cases', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For the calculation of this endpoint only the PCR-positive participants from the symptomatic group were counted.'}, {'type': 'SECONDARY', 'title': 'Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}], 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '96.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Description of relationship between days since symptom onset and Dräger test performance.\n\nPresented is the sensitivity(true positive rate) in the symptomatic group at days since symptom onset \\<5', 'unitOfMeasure': 'percentage of true positive cases', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For the calculation of this endpoint only the PCR-positive participants from the symptomatic group were counted.'}, {'type': 'SECONDARY', 'title': 'Specificity in Asymptomatic Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001', 'lowerLimit': '96.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Specificity of the antigen test in at least 100 asymptomatic participants', 'unitOfMeasure': 'percentage of true negative cases', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For the calculation of this endpoint only the PCR-negative participants from the asymptomatic group were counted.'}, {'type': 'SECONDARY', 'title': 'Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Record of occurrence of lasting nosebleed or unbearable pain during or immediately after specimen collection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}, {'id': 'FG001', 'title': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'PCR results not accessible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'incomplete documentation of kit assessment prior to testing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}, {'id': 'BG001', 'title': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2\n\nDräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '73'}, {'value': '32.5', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '61'}, {'value': '34.0', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '177', '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': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-11', 'size': 905616, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-19T00:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'whyStopped': 'poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2021-01-05', 'resultsFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-23', 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Sensitivity (true positive rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \\>=10\\^6 RNA copies/ml for positive PCR results)'}, {'measure': 'Specificity', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Specificity (true negative rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \\>=10\\^6 RNA copies/ml for positive PCR results)'}], 'secondaryOutcomes': [{'measure': 'Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Description of relationship between cycle threshold value of the reference RT-PCR and Dräger test performance.\n\nPresented is the sensitivity(true positive rate) in the symptomatic group at a cycle threshold of \\<22'}, {'measure': 'Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Description of relationship between days since symptom onset and Dräger test performance.\n\nPresented is the sensitivity(true positive rate) in the symptomatic group at days since symptom onset \\<5'}, {'measure': 'Specificity in Asymptomatic Participants', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Specificity of the antigen test in at least 100 asymptomatic participants'}, {'measure': 'Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection', 'timeFrame': 'Through study completion, an average of 1 1/2 month', 'description': 'Record of occurrence of lasting nosebleed or unbearable pain during or immediately after specimen collection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antigen test'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.', 'detailedDescription': "The Dräger Antigen Test SARS-CoV-2 is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleoprotein directly from less invasive nasal swabs, to be performed at the point of care. The test kit contains all components required to carry out a test detecting SARS-CoV-2 nucleoprotein.\n\nThe study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.\n\nThe goal of the study is to compare Dräger test results to the corresponding PCR data for overall sensitivity and specificity. Specimens are collected from patients showing COVID-19 symptoms as well as asymptomatic participants. Participants are recruited across all genders and eligible age groups. Study staff records participants' information such as symptoms and time since symptom onset. For each study participant, the specimen for RT-PCR is collected first, then the Dräger test specimen. The Dräger test result is read after 15 min to 20 min."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must require SARS-CoV-2 testing for the following reasons:\n\n * COVID-19 symptoms (Fever, cough and/or sore throat, fatigue/ general feeling of weakness, loss of sense of smell and/or taste, shortness of breath, muscle stiffness/ body aches, head cold/ running nose, etc.) on the day of testing, or\n * Known or suspected exposure to SARS-CoV-2 (contact persons etc.), or\n * Member of a group of high risk of exposure such as healthcare workers etc., or\n * Require screening for any other reason, e.g. doctor's orders, hygiene directive etc.\n* Participant must be of legal age and must be able to understand the procedure and letter of consent.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old are excluded from the study.\n* Pregnant or breastfeeding patients are excluded from the study.\n* Patients unable to provide written informed consent are excluded.\n* Patients with bleeding disorder are excluded from the study as a precaution.\n* Hospitalized patients/inpatients are excluded.\n* Application of nasal spray within 15 min prior to testing.\n* Participants with symptoms on the day of testing are excluded, if any of their symptoms started more than 14 days prior to testing.\n* Asymptomatic participants are excluded, if they experienced any symptoms in the 14 days prior to testing."}, 'identificationModule': {'nctId': 'NCT04698993', 'briefTitle': 'Dräger COVID-19 Antigen Test Clinical Performance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Drägerwerk AG & Co. KGaA'}, 'officialTitle': 'Dräger Antigen Test SARS-CoV-2 Clinical Performance Study', 'orgStudyIdInfo': {'id': 'Dräger Antigen Test SARS-CoV-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Symptomatic', 'description': 'Collection of specimens from symptomatic COVID-19 positive participants', 'interventionNames': ['Diagnostic Test: Dräger Antigen Test SARS-CoV-2']}, {'type': 'OTHER', 'label': 'Asymptomatic', 'description': 'Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2', 'interventionNames': ['Diagnostic Test: Dräger Antigen Test SARS-CoV-2']}], 'interventions': [{'name': 'Dräger Antigen Test SARS-CoV-2', 'type': 'DIAGNOSTIC_TEST', 'description': 'Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test', 'armGroupLabels': ['Asymptomatic', 'Symptomatic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Daniel Zickler, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drägerwerk AG & Co. KGaA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}