Coronavirus Disease 2019 (COVID-19), SARS-CoV-2
Conditions
Keywords
COVID-19, SARS-CoV-2, Public Health Surveillance, Participants in NIH-funded studies (and their families)
Brief summary
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
Detailed description
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. The 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. The 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.
Interventions
PROCEDURECollection of Biological Samples
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.
PROCEDURESymptom and Exposure Surveys
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.
Sponsors
Rho Federal Systems Division, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Household members who meet all of the following criteria are eligible for enrollment as study participants: * 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: * ≤21 years of age, and * Lives with caregiver(s). * The index participant and/or caregiver understands the study procedures and is willing to conduct these procedures at home; * Have the ability to use either a computer or a smart phone to link to and respond to the study questionnaires: --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. * The index participant and caregiver will reside in the United States, including Puerto Rico, for the duration of the study; * The index participant will live with the caregiver for at least 50% of the time for the duration of the study; * An English or Spanish speaker is available to: * Serve as the primary contact, and * As the person who will be responsible for the completion of questionnaires and the collection of study biological samples; and, * 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.
Exclusion criteria
-Past or current medical problems, which, in the opinion of the site investigator may: * Pose risks from participation in the study * Interfere with the participant's ability to comply with study requirements, or * Impact the quality or interpretation of the data obtained from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to Week 24 | 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. |
| 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 | Through study completion, an average of 24 Weeks | 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). |
| 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 | Up to Week 24 | 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. |
| 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 | Up to Week 24 | 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. |
| Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period | Up to Week 24 | 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). |
| 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 | Up to Week 24 | 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 |
| 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 | Up to Week 24 | 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. |
| 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 | Baseline, Week 24 | 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. |
| Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period | Up to Week 24 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Index Participants 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. | 1,387 |
| Non-Index Participants 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. | 2,755 |
| Total | 4,142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 203 | 380 |
| Overall Study | Moved | 0 | 2 |
| Overall Study | Noncompliance with study procedure | 121 | 251 |
| Overall Study | Nonresponsive | 0 | 5 |
| Overall Study | Reimbursement not enough | 1 | 2 |
| Overall Study | Test too painful | 1 | 1 |
| Overall Study | Unforeseen family circumstances | 1 | 3 |
| Overall Study | Withdrawal by Subject | 47 | 98 |
Baseline characteristics
| Characteristic | Total | Non-Index Participants | Index Participants |
|---|---|---|---|
| Age, Continuous | 25.0 years STANDARD_DEVIATION 16.8 | 32.3 years STANDARD_DEVIATION 15.8 | 10.3 years STANDARD_DEVIATION 4.9 |
| Allergies (hay fever, rhinitis) No | 2250 Participants | 1548 Participants | 702 Participants |
| Allergies (hay fever, rhinitis) Yes | 1892 Participants | 1207 Participants | 685 Participants |
| Asthma No | 2992 Participants | 2133 Participants | 859 Participants |
| Asthma Yes | 1150 Participants | 622 Participants | 528 Participants |
| Eczema No | 3420 Participants | 2419 Participants | 1001 Participants |
| Eczema Yes | 722 Participants | 336 Participants | 386 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 476 Participants | 302 Participants | 174 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3590 Participants | 2406 Participants | 1184 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 76 Participants | 47 Participants | 29 Participants |
| Food Allergies No | 3493 Participants | 2449 Participants | 1044 Participants |
| Food Allergies Yes | 649 Participants | 306 Participants | 343 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 30 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) Asian | 78 Participants | 55 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 883 Participants | 563 Participants | 320 Participants |
| Race (NIH/OMB) More than one race | 169 Participants | 83 Participants | 86 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 270 Participants | 177 Participants | 93 Participants |
| Race (NIH/OMB) White | 2705 Participants | 1854 Participants | 851 Participants |
| Region of Enrollment United States | 4142 participants | 2755 participants | 1387 participants |
| Sex/Gender, Customized Female | 2403 Participants | 1756 Participants | 647 Participants |
| Sex/Gender, Customized Intersex | 4 Participants | 3 Participants | 1 Participants |
| Sex/Gender, Customized Male | 1727 Participants | 993 Participants | 734 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 8 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,387 | 0 / 2,755 |
| other Total, other adverse events | 14 / 1,387 | 4 / 2,755 |
| serious Total, serious adverse events | 0 / 1,387 | 0 / 2,755 |
Outcome results
Primary
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period
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.
Time frame: Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 30 Days | 98.9 Percent surviving using Kaplan-Meier |
| Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 60 Days | 98.0 Percent surviving using Kaplan-Meier |
| Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 90 Days | 97.2 Percent surviving using Kaplan-Meier |
| Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 120 Days | 95.8 Percent surviving using Kaplan-Meier |
| Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 150 Days | 94.2 Percent surviving using Kaplan-Meier |
| Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 180 Days | 90.5 Percent surviving using Kaplan-Meier |
| Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 210 Days | 90.1 Percent surviving using Kaplan-Meier |
| Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 212 Days | 90.1 Percent surviving using Kaplan-Meier |
| Non-Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 90 Days | 97.7 Percent surviving using Kaplan-Meier |
| Non-Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 210 Days | 88.4 Percent surviving using Kaplan-Meier |
| Non-Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 120 Days | 96.1 Percent surviving using Kaplan-Meier |
| Non-Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 150 Days | 94.3 Percent surviving using Kaplan-Meier |
| Non-Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 180 Days | 91.4 Percent surviving using Kaplan-Meier |
| Non-Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 30 Days | 99.2 Percent surviving using Kaplan-Meier |
| Non-Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 60 Days | 98.4 Percent surviving using Kaplan-Meier |
| Non-Index Participants | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 212 Days | 83.5 Percent surviving using Kaplan-Meier |
| All Participants Combined | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 90 Days | 97.5 Percent surviving using Kaplan-Meier |
| All Participants Combined | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 60 Days | 98.3 Percent surviving using Kaplan-Meier |
| All Participants Combined | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 30 Days | 99.1 Percent surviving using Kaplan-Meier |
| All Participants Combined | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 120 Days | 96.0 Percent surviving using Kaplan-Meier |
| All Participants Combined | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 210 Days | 89.0 Percent surviving using Kaplan-Meier |
| All Participants Combined | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 180 Days | 91.1 Percent surviving using Kaplan-Meier |
| All Participants Combined | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 150 Days | 94.3 Percent surviving using Kaplan-Meier |
| All Participants Combined | Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period | 212 Days | 85.7 Percent surviving using Kaplan-Meier |
Secondary
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
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.
Time frame: Baseline, Week 24
Secondary
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
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.
Time frame: Up to Week 24
Secondary
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
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.
Time frame: Up to Week 24
Secondary
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
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.
Time frame: Up to Week 24
Secondary
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
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
Time frame: Up to Week 24
Secondary
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
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.
Time frame: Up to Week 24
Secondary
Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period
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).
Time frame: Up to Week 24
Secondary
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
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).
Time frame: Through study completion, an average of 24 Weeks
Secondary
Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period
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.
Time frame: Up to Week 24