N/A
N=4,142
COVID-19: Human Epidemiology and Response to SARS-CoV-2
Coronavirus Disease 2019 (COVID-19) · SARS-CoV-2
Bottom Line
View on ClinicalTrials.gov: NCT04375761 ↗Enrolled (actual)
4,142
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period — 98.9; 99.2; 99.1; 98.0 Percent surviving using Kaplan-Meier
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Collection of Biological Samples (Procedure); Symptom and Exposure Surveys (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period |
98.9; 99.2; 99.1; 98.0; 98.4; 98.3 | — |
| SECONDARY Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period |
— | — |
| 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 |
— | — |
| 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 |
— | — |
| 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 |
— | — |
| 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 |
— | — |
| SECONDARY Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period |
— | — |
| 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 |
— | — |
| 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 |
— | — |
| 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 |
— | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04375761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.