跳至主要内容
临床试验/NCT04367857
NCT04367857招募中不适用

SARS-CoV-2 Seroprevalence Among Healthcare Workers: ARMOR Study Demonstration Project

Columbia University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Proportion seropositive

研究概览

简要总结

The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.

详细描述

The rapid spread of the novel coronavirus SARS-CoV-2 has resulted in pandemic levels and a global challenge in diagnosing infection. Diagnosing infection, defining recovery and immunity has been challenging. Health care providers in particular are very interested in knowing their status as they are highly exposed, and if infectious, can potentially transmit infection nosocomially (in the healthcare workplace setting) and to their household. In addition to understanding their exposure risk, infectious period, and immunity status, health care workers are reporting high levels of psychosocial distress including anxiety and burnout. The investigators aim to assess the baseline and cumulative seroprevalence of SARS-CoV-2 among health care workers using both quantitative and qualitative serological assays; describe psychosocial well-being and coping strategies among health workers in their institutional settings and describe how knowledge of one's serostatus affect psychosocial well-being, and coping strategies. Findings from this study will inform; 1) use of serological assays and testing algorithms, and 2) approaches to manage psychosocial stress for healthcare workers.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • NewYork-Presbyterian (NYP) healthcare personnel employee or affiliate
  • Understands and reads English

排除标准

  • Younger than 18 years of age
  • Mentally and/or physically unable to complete study requirements

研究组 & 干预措施

Never tested and asymptomatic

Never tested and asymptomatic for COVID-19 symptoms, including asymptomatic health care worker

干预措施: COVID-19 Serology (Other)

Never tested and asymptomatic

Never tested and asymptomatic for COVID-19 symptoms, including asymptomatic health care worker

干预措施: Health Care Worker Survey (Behavioral)

Prior Positive polymerase chain reaction (PCR) and Recovered

Prior Positive PCR result, fully recovered, back at work and symptom free for greater than or equal than 14 days.

干预措施: COVID-19 Serology (Other)

Prior Positive polymerase chain reaction (PCR) and Recovered

Prior Positive PCR result, fully recovered, back at work and symptom free for greater than or equal than 14 days.

干预措施: Health Care Worker Survey (Behavioral)

Never tested, history of COVID-19 Symptoms and Recovered

Never tested and history of COVID-19 symptoms and symptom-free for more than 14 days

干预措施: COVID-19 Serology (Other)

Never tested, history of COVID-19 Symptoms and Recovered

Never tested and history of COVID-19 symptoms and symptom-free for more than 14 days

干预措施: Health Care Worker Survey (Behavioral)

Never tested and current COVID-19 Symptoms

Never tested and current COVID-19 Symptoms (e.g. referred by a provider or clinic)

干预措施: COVID-19 Serology (Other)

Never tested and current COVID-19 Symptoms

Never tested and current COVID-19 Symptoms (e.g. referred by a provider or clinic)

干预措施: Health Care Worker Survey (Behavioral)

结局指标

主要结局

Proportion seropositive

时间窗: Up to 12 months after collection visit

Percentage of health care workers with positive serological markers to describe patterns in exposure, re-infection, clinical symptom, serological responses among health care workers based on their baseline serological status over a one year period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验