跳至主要内容
临床试验/NCT04387890
NCT04387890Unknown不适用

Serologic Surveillance for SARS-CoV-2 (COVID-19) in a Prospective Cohort of Health Care

Hospital Italiano de Buenos Aires0 个研究点目标入组 50 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
COVID-19 incidence through serology-based screening and/or compatible symptoms in health personnel previously known to be unexposed to the virus

研究概览

简要总结

The investigators will follow a single prospective cohort of 50 Health Care Workers in the Hospital Italiano de Buenos Aires (Argentina) from May 15th to August 31st 2020 using antibody testing for SARS-CoV-2 IgM and IgG at baseline and every 2 weeks in order to assess the incidence of COVID-19, the prevalence of anti-SARS-CoV-2 antibodies (IgM and IgG) and incidence of reinfection or reactivations of previous COVID-19 using viral gene sequencing in this cohort.

详细描述

SARS-CoV-2 infection in healthcare workers (HCW) is nowadays a frequent problem for patient care and organization of care teams. SARS-CoV-2 antibody assessment provides a tool to evaluate antibody prevalence in hospital staff identifying previously exposed individuals. Serologic testing could identify new cases of COVID-19 in an early fashion and could help to investigate cases of reactivation or reinfection in hospital workers. The study purpose is to conduct a study using serological screening for health care workers in a University Hospital in Buenos Aires in order to assess the risk of COVID-19 on those who have not developed an immune response against the virus, or to detect it in an early fashion (either pre-symptomatic or asymptomatic). If a study participant is suspected to have potential reinfection or reactivation of COVID-19, the investigators will conduct genome sequencing in order to be able to differentiate each case. The investigators will include 50 participants chosen at random among health care workers from the hospital Emergency Department (ED), Internal Medicine wards, or Critical Care Units who are exposed to COVID-19. Participants who agree to join the study and sign the informed consent form will be screened at baseline for SARS-CoV-2 IgM and IgG antibodies, along with a physical exam and basic laboratory determinations. They will be re-screened with antibodies every 2 weeks for a total of 3 months. If they contract COVID-19, antibody determinations and nasopharyngeal swabs will be carried out in order to identify those who are in favorable conditions to return to work. The main objective is to prospectively determine the incidence of COVID-19, Anti SARS-CoV-2 antibody prevalence, and incidence of SARS-CoV-2 reinfection or reactivation of COVID-19 in a health care workers cohort.

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

  • Healthcare staff (Physicians) AND
  • Directly involved in care of patients with confirmed or suspected COVID-19 AND
  • Working in any of the two hospital venues (Hospital Italiano Central and Hospital Italiano San Justo Agustín Rocca).

排除标准

  • Refusal to sign the Informed Consent Form OR
  • Experienced symptoms compatible with COVID-19 in the last 14 days prior to eligibility screening

结局指标

主要结局

COVID-19 incidence through serology-based screening and/or compatible symptoms in health personnel previously known to be unexposed to the virus

时间窗: During 3 months follow up

Patients that has a positive result for IgM or IgG or PCR during follow up

Prevalence of anti SARS-CoV-2 antibodies (IgM and IgG) in health personnel

时间窗: Baseline at study inclussion

Patients that has a positive result for IgM or IgG at baseline first test

Incidence of reactivation/reinfection for COVID-19 in health personnel with a positive serology for SARS-CoV-2

时间窗: During 3 months follow up

Patients with confirmed previous SARS Cov 2 antibodies that reactivate symptomons or new increase in antibodies title during follow up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diego Hernan Giunta, PhD, MPH, MD

MD, MPH, University SoTL, PhD

Hospital Italiano de Buenos Aires

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