Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-27 @ 2:42 PM
Study NCT ID:
NCT04375761
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19: Human Epidemiology and Response to SARS-CoV-2
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': 'DAITClinicalTrialsGov@niaid.nih.gov', 'phone': '301-594-7669', 'title': 'Director, Clinical Research Operations Program', 'organization': 'DAIT/NIAID'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '34.4% of nasal collections were missed during the study period.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew.', 'description': 'Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).', 'eventGroups': [{'id': 'EG000', 'title': 'Index Participants', 'description': 'Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study. This group is a subset of the group "All Participants Combined".', 'otherNumAtRisk': 1387, 'deathsNumAtRisk': 1387, 'otherNumAffected': 14, 'seriousNumAtRisk': 1387, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Index Participants', 'description': 'A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants except Index Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.', 'otherNumAtRisk': 2755, 'deathsNumAtRisk': 2755, 'otherNumAffected': 4, 'seriousNumAtRisk': 2755, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vessel puncture site hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vessel puncture site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vessel puncture site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1387, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1387', 'groupId': 'OG000'}, {'value': '2755', 'groupId': 'OG001'}, {'value': '4142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Index Participants', 'description': 'Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study. This group is a subset of the group "All Participants Combined".'}, {'id': 'OG001', 'title': 'Non-Index Participants', 'description': 'A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants except Index Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.'}, {'id': 'OG002', 'title': 'All Participants Combined', 'description': 'A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.'}], 'classes': [{'title': '30 Days', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '99.1'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '98.8', 'upperLimit': '99.5'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '98.8', 'upperLimit': '99.4'}]}]}, {'title': '60 Days', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '98.8'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '98.9'}, {'value': '98.3', 'groupId': 'OG002', 'lowerLimit': '97.9', 'upperLimit': '98.7'}]}]}, {'title': '90 Days', 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '98.1'}, {'value': '97.7', 'groupId': 'OG001', 'lowerLimit': '97.1', 'upperLimit': '98.3'}, {'value': '97.5', 'groupId': 'OG002', 'lowerLimit': '97.0', 'upperLimit': '98.0'}]}]}, {'title': '120 Days', 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '96.9'}, {'value': '96.1', 'groupId': 'OG001', 'lowerLimit': '95.3', 'upperLimit': '96.9'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '95.3', 'upperLimit': '96.6'}]}]}, {'title': '150 Days', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '92.9', 'upperLimit': '95.6'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '95.2'}, {'value': '94.3', 'groupId': 'OG002', 'lowerLimit': '93.5', 'upperLimit': '95.1'}]}]}, {'title': '180 Days', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '92.7'}, {'value': '91.4', 'groupId': 'OG001', 'lowerLimit': '90.1', 'upperLimit': '92.7'}, {'value': '91.1', 'groupId': 'OG002', 'lowerLimit': '90.0', 'upperLimit': '92.2'}]}]}, {'title': '210 Days', 'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000', 'lowerLimit': '87.9', 'upperLimit': '92.4'}, {'value': '88.4', 'groupId': 'OG001', 'lowerLimit': '85.3', 'upperLimit': '91.7'}, {'value': '89.0', 'groupId': 'OG002', 'lowerLimit': '86.8', 'upperLimit': '91.3'}]}]}, {'title': '212 Days', 'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000', 'lowerLimit': '87.9', 'upperLimit': '92.4'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '89.9'}, {'value': '85.7', 'groupId': 'OG002', 'lowerLimit': '81.5', 'upperLimit': '90.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)', 'description': 'Nasal samples were analyzed to determine whether a participant ever tested positive for SARS-CoV-2 or not over the course of the study. Kaplan-Meier was used to estimate survival probabilities at timepoints throughout the study. Participants were censored if they did not test positive for SARS-CoV-2 by the end of follow-up. The last positive nasal swab occurred at day 212.', 'unitOfMeasure': 'Percent surviving using Kaplan-Meier', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.'}, {'type': 'SECONDARY', 'title': 'Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts.\n\nOutcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.\n\nTesting method: Positive test result(s) for SARS-CoV-2 RNA in nasal samples.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percent of Index Participants With Asthma and Other Atopic Disease With Detectable SARS-CoV-2-Specific Antibodies in Serum Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period', 'timeFrame': 'Through study completion, an average of 24 Weeks', 'description': 'Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.\n\nOutcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Nasal samples of participants currently or previously enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts that test positive for SARS-CoV-2, will undergo transcriptome analysis.\n\nTotal RNA will be isolated for cDNA synthesis and amplification. Differential gene expression analysis be pursued.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Nasal samples of index participants that test positive for SARS-CoV-2 will be evaluated by transcriptome analysis. Differential gene expression analysis at different timepoints in the disease process will be analyzed.\n\nDefinition of index participant(s): Prior and/or current NIH-funded clinical research study participant(s) who fulfill inclusion criteria.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'An analysis of symptoms associated with positive SARS-CoV-2 RNA tests in nasal samples will be conducted.\n\nIncluded in analysis: Index participants and their household contacts.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical Steroids Compared to Index Participants That Are Not Using Topical Steroids Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.\n\nTests: Positive for SARS-CoV-2 RNA in nasal samples', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical, Oral, or Inhaled Steroids Compared to Index Participants That Are Not Using Topical, Oral, or Inhaled Steroids During the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.\n\nTests: Positive for SARS-CoV-2 RNA in nasal samples.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Analysis of Factors, Baseline and Prior History, for Possible Association With the Cumulative Incidence of SARS-COV-2 Detection in Nasal Samples: Index Participants and Their Household Contacts Over the Study/Surveillance Period', 'timeFrame': 'Baseline, Week 24', 'description': 'An exploratory analysis will be conducted for detection of possible associations, focusing on baseline demographic and environment factors and/or history of bronchiolitis prior history with the cumulative incidence of SARS-CoV-2 detection in nasal samples Test: Positive for SARS-CoV-2 RNA in nasal samples.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Index Participants', 'description': 'Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study. This group is a subset of the group "All Participants Combined".'}, {'id': 'FG001', 'title': 'Non-Index Participants', 'description': 'A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants excluding the index participants.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Index participants who were enrolled and contributed at least 1 nasal swab', 'groupId': 'FG000', 'numSubjects': '1387'}, {'comment': 'All participants who were enrolled and contributed at least 1 nasal swab', 'groupId': 'FG001', 'numSubjects': '2755'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Index participants who at least started the exit survey', 'groupId': 'FG000', 'numSubjects': '1012'}, {'comment': 'Participants who at least started the exit survey', 'groupId': 'FG001', 'numSubjects': '2011'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '375'}, {'groupId': 'FG001', 'numSubjects': '744'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '380'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'Noncompliance with study procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'Reimbursement not enough', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Unforeseen family circumstances', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Test too painful', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Nonresponsive', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 01May2022 through 17Dec2020. Children and teenagers who were participating in NIH-funded cohorts that focused on asthma and/or allergic disease were recruited. In addition to the cohort-participating child, enrollment required a household caregiver; an additional household child and adult could also be enrolled.', 'preAssignmentDetails': 'The study was performed remotely. Participants completed a registration form and questionnaires/surveys electronically. Participants did a web-based training that described sample collection and handling, teletraining, \\& were provided written instructions. Study staff were available by phone, text, or video conferencing.The 2 main groups of interest in this study were "Index Participants" (the cohort-participating child) \\& "All Participants Combined" (index participant and household contacts).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1387', 'groupId': 'BG000'}, {'value': '2755', 'groupId': 'BG001'}, {'value': '4142', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Index Participants', 'description': 'Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.'}, {'id': 'BG001', 'title': 'Non-Index Participants', 'description': 'A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants except Index Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '32.3', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '25.0', 'spread': '16.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '647', 'groupId': 'BG000'}, {'value': '1756', 'groupId': 'BG001'}, {'value': '2403', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '734', 'groupId': 'BG000'}, {'value': '993', 'groupId': 'BG001'}, {'value': '1727', 'groupId': 'BG002'}]}]}, {'title': 'Intersex', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '476', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1184', 'groupId': 'BG000'}, {'value': '2406', 'groupId': 'BG001'}, {'value': '3590', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '320', 'groupId': 'BG000'}, {'value': '563', 'groupId': 'BG001'}, {'value': '883', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '851', 'groupId': 'BG000'}, {'value': '1854', 'groupId': 'BG001'}, {'value': '2705', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1387', 'groupId': 'BG000'}, {'value': '2755', 'groupId': 'BG001'}, {'value': '4142', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Asthma', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '528', 'groupId': 'BG000'}, {'value': '622', 'groupId': 'BG001'}, {'value': '1150', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '859', 'groupId': 'BG000'}, {'value': '2133', 'groupId': 'BG001'}, {'value': '2992', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants who reported asthma on the baseline survey', 'unitOfMeasure': 'Participants'}, {'title': 'Food Allergies', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '343', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '649', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1044', 'groupId': 'BG000'}, {'value': '2449', 'groupId': 'BG001'}, {'value': '3493', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants who reported food allergies on the baseline survey', 'unitOfMeasure': 'Participants'}, {'title': 'Eczema', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '386', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '722', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1001', 'groupId': 'BG000'}, {'value': '2419', 'groupId': 'BG001'}, {'value': '3420', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants who reported eczema (atopic dermatitis) on the baseline survey', 'unitOfMeasure': 'Participants'}, {'title': 'Allergies (hay fever, rhinitis)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '685', 'groupId': 'BG000'}, {'value': '1207', 'groupId': 'BG001'}, {'value': '1892', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '702', 'groupId': 'BG000'}, {'value': '1548', 'groupId': 'BG001'}, {'value': '2250', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants who reported allergies (hay fever, rhinitis) on the baseline survey', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-02', 'size': 493699, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-25T12:50', 'hasProtocol': True}, {'date': '2020-04-30', 'size': 141930, 'label': 'Informed Consent Form: Final ICF', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-13T14:58', 'hasProtocol': False}, {'date': '2020-08-31', 'size': 137032, 'label': 'Informed Consent Form: Adjustment ICF', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-13T15:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasal, peripheral blood and stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5599}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2020-04-30', 'resultsFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-16', 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period', 'timeFrame': 'Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)', 'description': 'Nasal samples were analyzed to determine whether a participant ever tested positive for SARS-CoV-2 or not over the course of the study. Kaplan-Meier was used to estimate survival probabilities at timepoints throughout the study. Participants were censored if they did not test positive for SARS-CoV-2 by the end of follow-up. The last positive nasal swab occurred at day 212.'}], 'secondaryOutcomes': [{'measure': 'Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts.\n\nOutcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).'}, {'measure': 'Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.\n\nTesting method: Positive test result(s) for SARS-CoV-2 RNA in nasal samples.'}, {'measure': 'Percent of Index Participants With Asthma and Other Atopic Disease With Detectable SARS-CoV-2-Specific Antibodies in Serum Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period', 'timeFrame': 'Through study completion, an average of 24 Weeks', 'description': 'Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.\n\nOutcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).'}, {'measure': 'Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Nasal samples of participants currently or previously enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts that test positive for SARS-CoV-2, will undergo transcriptome analysis.\n\nTotal RNA will be isolated for cDNA synthesis and amplification. Differential gene expression analysis be pursued.'}, {'measure': 'Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Nasal samples of index participants that test positive for SARS-CoV-2 will be evaluated by transcriptome analysis. Differential gene expression analysis at different timepoints in the disease process will be analyzed.\n\nDefinition of index participant(s): Prior and/or current NIH-funded clinical research study participant(s) who fulfill inclusion criteria.'}, {'measure': 'Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'An analysis of symptoms associated with positive SARS-CoV-2 RNA tests in nasal samples will be conducted.\n\nIncluded in analysis: Index participants and their household contacts.'}, {'measure': 'Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical Steroids Compared to Index Participants That Are Not Using Topical Steroids Over the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.\n\nTests: Positive for SARS-CoV-2 RNA in nasal samples'}, {'measure': 'Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical, Oral, or Inhaled Steroids Compared to Index Participants That Are Not Using Topical, Oral, or Inhaled Steroids During the Study/Surveillance Period', 'timeFrame': 'Up to Week 24', 'description': 'Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.\n\nTests: Positive for SARS-CoV-2 RNA in nasal samples.'}, {'measure': 'Analysis of Factors, Baseline and Prior History, for Possible Association With the Cumulative Incidence of SARS-COV-2 Detection in Nasal Samples: Index Participants and Their Household Contacts Over the Study/Surveillance Period', 'timeFrame': 'Baseline, Week 24', 'description': 'An exploratory analysis will be conducted for detection of possible associations, focusing on baseline demographic and environment factors and/or history of bronchiolitis prior history with the cumulative incidence of SARS-CoV-2 detection in nasal samples Test: Positive for SARS-CoV-2 RNA in nasal samples.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-CoV-2', 'Public Health Surveillance', 'Participants in NIH-funded studies (and their families)'], 'conditions': ['Coronavirus Disease 2019 (COVID-19)', 'SARS-CoV-2']}, 'referencesModule': {'references': [{'pmid': '40795882', 'type': 'DERIVED', 'citation': "Moore CM, Secor EA, Everman JL, Fairbanks-Mahnke A, Jackson N, Pruesse E, Diener K, Morin A, Arbes SJ, Bacharier LB, Bendixsen CG, Calatroni A, Dupont WD, Furuta GT, Gebretsadik T, Gruchalla RS, Gupta RS, Khurana Hershey GK, Kattan M, Liu AH, Lussier SJ, Murrison LB, Numata M, O'Connor GT, River-Spoljaric K, Phipatanakul W, Rothenberg ME, Seroogy CM, Zoratti EM, Castina S, Jackson DJ, Camargo CA Jr, Johnson CC, Ethridge R, Ramratnam S, Stelzig L, Teach SJ, Togias AG, Fulkerson PC, Hartert TV, Seibold MA. The common cold is associated with protection from SARS-CoV-2 Infections. J Infect Dis. 2025 Aug 11:jiaf374. doi: 10.1093/infdis/jiaf374. Online ahead of print."}, {'pmid': '38775275', 'type': 'DERIVED', 'citation': "Fulkerson PC, Lussier SJ, Bendixsen CG, Castina SM, Gebretsadik T, Marlin JS, Russell PB, Seibold MA, Everman JL, Moore CM, Snyder BM, Thompson K, Tregoning GS, Wellford S, Arbes SJ, Bacharier LB, Calatroni A, Camargo CA Jr, Dupont WD, Furuta GT, Gruchalla RS, Gupta RS, Hershey GK, Jackson DJ, Johnson CC, Kattan M, Liu AH, Murrison L, O'Connor GT, Phipatanakul W, Rivera-Spoljaric K, Rothenberg ME, Seroogy CM, Teach SJ, Zoratti EM, Togias A, Hartert TV, Heros Study Team OBOT. Human Epidemiology and Response to SARS-CoV-2 (HEROS): objectives, design, and enrollment results of a 12-city remote observational surveillance study of households with children, using direct-to-participant methods. Am J Epidemiol. 2024 Oct 7;193(10):1329-1338. doi: 10.1093/aje/kwae077."}], 'seeAlsoLinks': [{'url': 'http://www.niaid.nih.gov/', 'label': 'National Institute of Allergy and Infectious'}, {'url': 'http://www.niaid.nih.gov/about/dait', 'label': 'Division of Allergy, Immunology, and Transplantation'}]}, 'descriptionModule': {'briefSummary': 'The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 presents as a mild to moderate respiratory illness. But it can also be more severe and even lead to death.\n\nThe purpose of this study is to:\n\n* Determine the prevalence of SARS-CoV-2 carrier status over time in children and parents\n* Determine the prevalence of antibody development over time in children and parents\n* Compare carrier status and antibody development for children with asthma and/or other atopic conditions (e.g. eczema) versus children without asthma and/or other atopic conditions\n* Investigate the presence of SARS-CoV-2 exposure in historical samples from enrolled participants', 'detailedDescription': 'The study population will include children that are participants in NIH-funded cohort studies and their families (household contacts).The intent is to recruit families that have experience with the collection of respiratory samples.\n\nThe objective of this surveillance study is to identify the rate of infection in children and what, if any effect, atopy has on the SARS-CoV-2 carrier status.\n\nThe initial surveillance interval for participants will be 6 months and, depending upon the findings, may be extended. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed remotely via a smart phone, on-line, or phone communications at the time the biological samples are collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'NIH-funded study participants (index participants) and their families This includes participants who have asthma and/or other atopic or allergic conditions, as well as healthy index participants, all with extensive medical information and information on atopic and allergic status available as a result of their participation in an NIH-funded study. As many of these are birth cohort studies, there is extensive information available on the parents. The majority of the families have experience with collection of respiratory samples and completing respiratory questionnaires.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nHousehold members who meet all of the following criteria are eligible for enrollment as study participants:\n\n* The index participant, defined as an individual who either is or has been a participant in an NIH-funded clinical research study from which information on respiratory conditions, including asthma, and other atopic and allergic diseases is available, is:\n\n * ≤21 years of age, and\n * Lives with caregiver(s).\n* The index participant and/or caregiver understands the study procedures and is willing to conduct these procedures at home;\n* Have the ability to use either a computer or a smart phone to link to and respond to the study questionnaires:\n\n --Exception: When the family is willing to speak with a study member to answer the questionnaires in the event of not having access to a computer or a smart phone.\n* The index participant and caregiver will reside in the United States, including Puerto Rico, for the duration of the study;\n* The index participant will live with the caregiver for at least 50% of the time for the duration of the study;\n* An English or Spanish speaker is available to:\n\n * Serve as the primary contact, and\n * As the person who will be responsible for the completion of questionnaires and the collection of study biological samples; and,\n* To participate as a sibling (of the index participant), must be under 21 years of age and live in the same home as the index participant and caregiver.\n\nExclusion Criteria:\n\n-Past or current medical problems, which, in the opinion of the site investigator may:\n\n* Pose risks from participation in the study\n* Interfere with the participant's ability to comply with study requirements, or\n* Impact the quality or interpretation of the data obtained from the study."}, 'identificationModule': {'nctId': 'NCT04375761', 'acronym': 'HEROS', 'briefTitle': 'COVID-19: Human Epidemiology and Response to SARS-CoV-2', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)', 'orgStudyIdInfo': {'id': 'DAIT-COVID-19-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS-CoV-2 Surveillance: Total Group', 'description': 'Participants either currently or in the past, enrolled in National Institutes of Health (NIH)-funded cohort studies, and their families (household contacts).\n\nActive surveillance for detection of SARS-CoV-2 for 6 months, beginning with enrollment. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed at the time that biological samples are collected.', 'interventionNames': ['Procedure: Collection of Biological Samples', 'Procedure: Symptom and Exposure Surveys']}], 'interventions': [{'name': 'Collection of Biological Samples', 'type': 'PROCEDURE', 'description': 'Biological samples will be collected throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. All biological samples (e.g. nasal swabs, peripheral blood, stool) will be collected by the caregiver at home using materials provided to the family. At the end of study, additional samples (e.g. nasal secretion and/or saliva samples) may be collected by the family or study staff at a site visit, if feasible.', 'armGroupLabels': ['SARS-CoV-2 Surveillance: Total Group']}, {'name': 'Symptom and Exposure Surveys', 'type': 'PROCEDURE', 'otherNames': ['Symptom and Exposure Questionnaires'], 'description': 'Symptom and exposure surveys (questionnaires) will be completed throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. The primary household contact/caregiver will be the designee for ensuring timely questionnaires completion and submission for all household study participants.', 'armGroupLabels': ['SARS-CoV-2 Surveillance: Total Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado: Inner City Asthma Consortium (ICAC) Site", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago: Food Allergy Outcomes Related to White and African American Racial Differences (FORWARD) and Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) Site", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital:Childhood Microbiome (CHIME) and Wheezing Index (WIND) Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital: School Inner-City Asthma Study (SICAS-2), Environmental Assessment of Sleep in Youth (EASY), Severe Asthma Research Program (SARP) and Preventing Asthma in High Risk Kids (PARK) Site", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center: Inner City Asthma Consortium (ICAC) Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System: Childhood Allergy Study (CAS) Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System: Inner City Asthma Consortium (ICAC) Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System: Microbes, Asthma, Allergy and Pets (MAAP) and Wayne County Health, Environment, Allergy, and Asthma Longitudinal Study (WHEALS) Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital: Inner City Asthma Consortium (ICAC) Site", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center: Inner City Asthma Consortium (ICAC) Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center: Greater Cincinnati Pediatric Clinic Repository (GCPCR) and Mechanisms of Progression of Atopic Dermatitis to Asthma in Children (MPAACH) Site", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center: Inner City Asthma Consortium (ICAC) Site", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center:Cincinnati Childhood Allergy & Air Pollution Study (CCAAPS) Site", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center: Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE) Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center: Inner City Asthma Consortium (ICAC) Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics: Childhood Origins of Asthma (COAST) Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics: Wisconsin Infant Study Cohort (WISC) Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Tina V. Hartert, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt University School of Medicine, Dept. of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Rho Federal Systems Division, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}