Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,599
- 试验地点
- 20
- 主要终点
- Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)