The COVID-19 Household Transmission Study (CO-HOST) - Epidemiology of SARS-CoV-2 Transmission Within the Household
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Number of Households with New SARS-CoV-2 Infection by Day 28
研究概览
简要总结
This study will test and follow persons quarantined at home after testing positive for SARS-CoV-2 (COV) aged 18 years and older and their household members aged 1 year and older.
The purpose of this research study is to understand how often COVID-19 (Coronavirus Disease 2019) spreads in the household when someone who tests positive for the virus self-isolates at home.
The purpose of the extension part of the study is to help us understand long-term immunity to COVID-19. We are interested in how our immune system might still protect us from COVID-19 even after antibody levels decrease or are no longer detected. We are also interested in how immunity to COVID-19 is different in kids vs. adults.
详细描述
This study will enroll approximately 200 men and women ≥ 18 years of age who are SARS-CoV-2 PCR positive undergoing home quarantine & approximately 200-1500 immediate household contacts, both male and female, ≥ 1 year of age.
This study will test and follow persons quarantined at home after testing positive for SARS-CoV-2 (COV) and their household members.
The CO-HOST mobile nurse initiates a home visit to the home of the COVID-19 index case after they and their household members (COV-HC) verbally express interest in the study and provide consent or assent as appropriate. At the first visit, nasopharyngeal (NP) swabs and blood are collected from COV and all members of the household (COV-HC) to determine infection status. Additional samples (nasal swabs, saliva, nasal strips), both nurse-collected and self-collected, may also be collected from COV and COV-HC. The nurse will provide specific instructions and training on how to perform self-collected swabs.
Every week, thereafter, COV-HC are tested during the 28 days of the study. If home visits are not possible, then participants will perform self-collected swabs for testing. If COV-HC develops symptoms, they will be referred per standard of care (SOC).
If COV or COV-HC are hospitalized, they will remain in the study for outcome assessment, but without further sample collections.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COVID-positive index cases (COV):
- •Any patient greater than or equal to18 years of age with a positive qualitative nasopharyngeal or nasal swab for SARS-CoV-2 obtained at UNC Hospitals or an outpatient clinic
- •COVID-19 diagnosis by positive NP swab
- •Willingness to self-isolate at home for a 14-day period
- •Living with at least one household contact who is also willing to consent to study follow-up
- •Living within reasonable driving distance (<1 hour) suitable for home visits by study team
- •Household contact of COVID-positive index case (COV-HC):
- •Household contacts greater than 1 year of age currently living in the same home as the COVID-positive index case without plans to leave to live elsewhere through the end of the 28-day study.
排除标准
- •COVID-positive index cases (COV): None
- •Household contact of COVID-positive index case (COV-HC):
- •Previously participated in this study (as index case or household contact)
- •For the extension part of CO-HOST, study participants greater than 65 years of age who tested positive for acute SAR-CoV-2 infection by PCR or seroconversion (antibody status became positive) during their participation in the first month of the study, will be eligible. They will be excluded if they previously received immunologic therapy (i.e., exogenous anti-SARS-CoV-2 monoclonal antibodies) for COVID-19 infection.
结局指标
主要结局
Number of Households with New SARS-CoV-2 Infection by Day 28
时间窗: 28 days
Secondary household infection rate
Risk Factors Associated with Secondary Household Transmission
时间窗: 28 days
Secondary household infection rate risk factors
次要结局
- Number of Self-Swab Tests vs. NP Swabs at Day 1 with Detectable Viral Load(1 day)