International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Certara
- 入组人数
- 6,808
- 试验地点
- 1
- 主要终点
- Occurrence of SARS-CoV-2 infection among HCWs caring for COVID-19 patients, in terms of time, geography, healthcare setting, type of HCW.
研究概览
简要总结
The International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global), is an international registry of approximately 10,000 healthcare workers in low- and middle-income countries experiencing increasing numbers of COVID-19 cases and commensurate increased exposure to the SARS-CoV-2 virus among their healthcare worker populations.
详细描述
The registry will enrol HCWs who are experiencing or are expected to experience ongoing and recurrent close contact with confirmed or clinically diagnosed COVID-19 patients. Recruitment for the registry will aim to enrol a representative distribution of HCWs on the front lines of diagnosing and caring for COVID-19 patients in both hospitals and community settings, as well as a balanced sample of HCWs receiving the most commonly administered putatively prophylactic drug regimens.
The registry will collect information on a weekly basis from HCWs across a 12-week period following their first known exposure to confirmed or clinically diagnosed COVID-19 patients prior to or within 30 days after enrollment. Data collection will include the drug regimens being taken by the HCWs, information about their level of exposure to COVID-19 patients, their personal health status, and other factors such as the use of PPE which would likely impact their risk of developing a SARS-CoV-2 infection.
A standard pharmaco-epidemiological inferential analysis will be conducted treating the registry data as a cohort with dynamic exposure to both prophylactic treatment and to COVID-19 infected patients and adjusting for potential confounding. Crude and adjusted hazards ratios will be estimated for each of the prophylactic regimens of interest and any observed impact on the risk of infection among HCWs based on all statistical inferential models will be reported
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Healthcare workers will be entered into this study only if they meet ALL the following criteria:
- •Healthcare workers aged ≥ 18 years.
- •Healthcare workers must be exposed through ongoing and recurrent contact to a confirmed or clinically diagnosed COVID-19 patient prior to enrollment, or anticipated within 30 days after enrollment.
- •Healthcare workers must consent to provide data for the registry and must be willing to be contacted/reminded about data entry at each follow-up time point.
- •Healthcare workers must agree to provide a secondary contact for follow-up.
排除标准
- •A confirmed SARS-CoV-2 infection or clinically diagnosed COVID-19 prior to the first known exposure to confirmed or clinically diagnosed COVID-19 patient (Index Date).
- •Participation in a 'blinded' clinical trial, i.e. unaware of exact treatment received as part of the clinical trial.
结局指标
主要结局
Occurrence of SARS-CoV-2 infection among HCWs caring for COVID-19 patients, in terms of time, geography, healthcare setting, type of HCW.
时间窗: 12 weeks
Assess the association of potential prophylactic treatments with reduced risk of COVID-19 (or SARS-CoV-2 infection) in HCWs caring for COVID-19 patients
次要结局
- Occurrence of SARS-CoV-2 uninfected HCWs(12 weeks)
- Occurrence of SARS-CoV-2 infection with ambulatory status and no limitation of activities(12 weeks)
- Occurrence of SARS-CoV-2 infection with ambulatory status and limitation of activities(12 weeks)
- Occurrence of hospitalization due to COVID-19 illness with mild disease(12 weeks)
- Occurrence of hospitalization due to COVID-19 illness with severe disease(12 weeks)
- Occurrence of all-cause mortality(12 weeks)
- Type of prophylactic treatments by dose, frequency and duration, overall and by country/region/site(12 weeks)