临床试验/NCT04658121

NCT04658121已完成不适用

SARS-CoV-2 Prevalence Study

COVID-19 Prevention Network24 个研究点分布在 2 个国家目标入组 26,211 人开始时间: 2021年2月4日最近更新: 2026年7月16日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 26,211
试验地点: 24
主要终点: To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The COVID-19 Prevention Network (CoVPN) is doing a study to estimate the number of people who have or have had the SARS-CoV-2 virus in different communities in the United States. This study is being done to help determine the best places to perform future research studies that will test new drugs for treatment or prevention of COVID-19.

详细描述

Design:

Cross-sectional surveys of (1) adults residing in senior living facilities and attending outpatient healthcare facilities, and (2) the general population in each selected research site community.

Population:

Adults residing in senior living facilities (nursing homes, assisted or independent living facilities) and attending outpatient healthcare facilities in neighborhoods of selected research sites
Adults and children (> 2 months of age) in neighborhoods of selected research sites

Study Size:

研究设计

研究类型: Observational
观察模型: Ecologic Or Community
时间视角: Cross Sectional

入排标准

年龄范围: 2 Months 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Adults residing in senior living facilities or attending outpatient healthcare facilities:
•At least 18 years of age
•Willing and able to provide informed consent or consent has been provided by legal representative (for those with mental incapacity in senior living facilities)
•Recruited from a selected facility
•Adults and children from select neighborhoods of research site communities:
•Adults and children > 2 months of age
•For individuals < 18 years old, a guardian must be present (in person or by phone for those 15 - 17 years old)
•Willing and able to provide consent (or assent for individuals 7-17 years old, parent/guardian will provide consent for all minors)
•Recruited from a selected venue

排除标准

•Previous enrollment in this study, either from the same or another CRS community.
•Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

结局指标

主要结局

To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites

时间窗: Baseline

To Estimate the Prevalence of SARS-CoV-2 IgG Seropositivity Among Individuals in Communities Surrounding Selected NIAID Clinical Research Sites

时间窗: Baseline

Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample for laboratory analysis.

次要结局

To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 through a study questionnaire(Baseline)
To estimate potential size of populations for referral to COVID-19 prevention and treatment studies(Baseline)
To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19(Baseline)
To estimate seroprevalence of SARS-CoV-2(Baseline)
To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing(Baseline)
To assess association between demographic, clinical and social factors with SARS-CoV-2 infection and seroprevalence, with particular interest in racial and ethnic health disparities.(Baseline)
To assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva samples(Baseline)
To Estimate Prevalence of SARS-CoV-2 Infection Based on Results of SARS-CoV-2 RNA Testing(Baseline)
To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Presence of Symptoms Consistent With COVID-19(Baseline)
To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Absence of Symptoms Consistent With COVID-19(Baseline)
To Estimate Seroprevalence of SARS-CoV-2 Among Those Without Past or Current Symptoms Consistent With COVID-19(Baseline)
To Estimate Seroprevalence of SARS-CoV-2 Among Those With no Prior Positive SARS-CoV-2 Testing, But Who Report Close Contact With Confirmed or Presumed Cases(Baseline)
To Estimate Seroprevalence of SARS-CoV-2 Among Those With History of Co-morbid Medical Conditions(Baseline)
To Assess Association Between Age and SARS-CoV-2 Infection and/or Seroprevalence(Baseline)
To Assess Association Between Sex and SARS-CoV-2 Infection and/or Seroprevalence(Baseline)
To Assess Association Between Race and SARS-CoV-2 Infection and/or Seroprevalence(Baseline)
To Assess Association Between Ethnicity and SARS-CoV-2 Infection and/or Seroprevalence(Baseline)
To Assess Association Between Education and SARS-CoV-2 Infection and/or Seroprevalence(Baseline)
To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those With Active COVID-19(Baseline)
To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those Who Have Serologic Evidence of Recent and/or Past SARS-CoV-2 Infection(Baseline)
To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those Who Have Negative RNA and Serologic SARS-CoV-2 Tests(Baseline)
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Face-masking(Baseline)
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Six-feet Distancing(Baseline)
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Avoiding Public Spaces(Baseline)
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Vaccine Willingness(Baseline)
To Assess Performance Characteristics of PCR-based and Serologic SARS-CoV-2 Tests Using Saliva Samples(Baseline)

研究者

发起方

COVID-19 Prevention Network

申办方类型

Network

责任方

Sponsor

研究点 (24)

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