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drug606 | Collection of Biological Samples Wiki | 1.00 |
drug2132 | SARS-CoV-2 Specific T Cells Wiki | 1.00 |
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There is one clinical trial.
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. The purpose of this study is to: - Determine the prevalence of SARS-CoV-2 carrier status over time in children and parents - Determine the prevalence of antibody development over time in children and parents - 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 - Investigate the presence of SARS-CoV-2 exposure in historical samples from enrolled participants
Description: Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts. Calculated at the end of surveillance/study follow-up or fate, defined as follows: Time from entry until the first of the following events: Tests positive for SARS-CoV-2 RNA in nasal samples Is lost to follow-up or withdraws from the study End of study (Week 24) Fate at the end of follow-up: 1 (positive): If the participant tests positive for SARS-CoV-2 0 (censored): If the participant has no evidence of having had disease by the end of follow-up
Measure: Cumulative Incidence of SARS-CoV-2 RNA Detection in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period Time: Up to Week 24Description: Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts. Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).
Measure: Percent of Index Participants and Their Household Contacts with Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period Time: Up to Week 24Description: Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Testing method: Positive test result(s) for SARS-CoV-2 RNA in nasal samples.
Measure: Cumulative Incidence of SARS-CoV-2 Detection in Nasal Samples Among Index Participants with Asthma and Other Atopic Disease Compared to Index Participants without Atopic Disease Over the Study/Surveillance Period Time: Up to Week 24Description: Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).
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 Time: Through study completion, an average of 24 WeeksDescription: 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. Total 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 and Their Household Contacts Over the Study/Surveillance Period Time: Up to Week 24Description: 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. Definition of index participant(s): Prior and/or current NIH-funded clinical research study participant(s) who fulfill inclusion criteria.
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 Time: Up to Week 24Description: An analysis of symptoms associated with positive SARS-CoV-2 RNA tests in nasal samples will be conducted. Included in analysis: Index participants and their household contacts.
Measure: Symptoms Associated with Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period Time: Up to Week 24Description: Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Tests:Positive for SARS-CoV-2 RNA in nasal samples
Measure: Cumulative Incidence of SARS-CoV-2 Detection in Nasal Samples Among Index Participants using Topical Steroids Compared to Index Participants that are Not Using Topical Steroids Over the Study/Surveillance Period Time: Up to Week 24Description: Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Tests: Positive for SARS-CoV-2 RNA in nasal samples.
Measure: Cumulative Incidence of SARS-CoV-2 Detection in Nasal Samples Among Index Participants Using Topical, Oral, or Inhaled Steroids Compared to Index Participants that are Not Using Topical, Oral, or Inhaled Steroids During the Study/Surveillance Period Time: Up to Week 24Description: 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.
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 Time: Baseline, Week 24