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Long-term COVID-19 Immune Response in a Vulnerable Neighbourhood in Argentina

2021年8月23日 更新者:ALICIA MISTCHENKO、Hospital Italiano de Buenos Aires

Long-term Persistence of Immunoglobulin G Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Vulnerable Neighbourhood in Buenos Aires, Argentina

Between June 10t h and July 1st, a cross-sectional design study in an Argentina slum, showed a prevalence based on immunoglobuling G-class (IgG) antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) of 53.4%. It remains unanswered whether natural infection produces sustained antibodies. The aim of this study is to evaluate the presence of IgG antibodies for Coronavirus disease 2019 (COVID-19) after 5 months in inhabitants of Barrio 31 who consented the Seroprevalence Study for COVID-19.

研究概览

地位

完全的

详细说明

Background Between June 10t h and July 1st, a cross-sectional design study was carried out in an Argentina slum over people, selected from a probabilistic sample of households showed a prevalence based on IgG-class antibodies against SARS-CoV-2 of 53.4%. In regarding to the persistence of these antibodies, the early data brought hope that acquired immunity was possible. But some subsequent studies have suggested that immune protection might be short-lived. The new findings show that people who survive a COVID-19 infection continue to produce protective antibodies against key parts of the virus for at least three to four months after developing their first symptoms. In contrast, some other antibody types decline more quickly.

It remains unanswered whether natural infection produces a sustained immunity that is capable of establishing herd immunity. The other health problem that Latin America faces is dengue, whose transmission, like SARS-CoV-2, is greater in areas with high population density such as vulnerable neighborhoods. In this context, the occurrence of the two diseases implies a risk, particularly in regions with several dengue serotypes where secondary and tertiary infections have been demonstrated and dengue epidemiological surveillance has been affected by the saturation of health system.

Objectives The aim of this study is to evaluate the presence of IgG antibodies for COVID-19 after 5 months in inhabitants of this slum who consented the Seroprevalence Study for COVID-19, and to evaluate those factors associated with the persistence of positive antibodies. As a secondary objective, the presence of positive IgG for dengue will be evaluated.

Methods Cross sectional study. Population of the study were inhabitants of the slum: men and women form 14 years of age or older were included. People will be invited to participated and detection of antibodies will be performed with ta serological tests, an enzyme linked immunosorbent assay (ELISA) developed and validated in Argentina which detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike protein. Blood sample will be collected in a capillary tube from a finger prick taken at the doorstep of each person. Samples will be processed and analyzed at the "Hospital de Niños Doctor Ricardo Gutierrez" Virology laboratory.

Blood sample collection and epidemiological data were collected, and entered in a secure database.

Sample Size The first seroprevalence study included 426 inhabitants of 14 years or more. Considering a persistence of antibodies of 30% with a precision of 5% for a confidence interval of 95% 184 inhabitants should be included. This sample will be selected by a proportionate stratified random sampling, considering the ten sectors in which the slum is divided.

Statistical analysis Descriptive statistics of the data will be carried out according to the variables obtained. Continuous variables will be expressed as mean and standard deviation, and categorical variables as proportions. A multiple logistic regression model will be performed to evaluate the factors associated with the persistence of positive antibodies for SARS-CoV-2.

Dengue seroprevalence is determined globally and by geographic sector. R software version 4.0.2 will be used.

研究类型

观察性的

注册 (实际的)

189

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ciudad De Buenos Aires
      • Buenos Aires、Ciudad De Buenos Aires、阿根廷、C1425EFD
        • Hospital de Niños Ricardo Gutiérrez

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 90年 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

inhabitants of Barrio Mugica: men and women form 14 years of age or older who were included in the first seroprevalence study carried on between Between June 10t h and July 1st, and who have positive antibodies against severe acute respiratory syndrome coronavirus 2

描述

Inclusion Criteria:

  • Men and women form 14 years of age or older who were included in the seroprevalence study and who have positive antibodies against severe acute respiratory syndrome coronavirus 2

Exclusion Criteria:

  • deny consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:横截面

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement
大体时间:up to 20 weeks
to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement
up to 20 weeks

次要结果测量

结果测量
措施说明
大体时间
to estimate the proportion of people with positive IgG antibodies for dengue
大体时间:up to 20 weeks
to estimate the proportion of people with positive IgG antibodies for dengue
up to 20 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Vanina Pagotto, MD MG、Hospital Italiano de Buenos Aires
  • 首席研究员:Alicia Mistchenko, Phd、Hospital de Niños Ricardo Gutiérrez
  • 学习椅:Silvana Figar, MD MG、Hospital Italiano de Buenos Aires
  • 学习椅:Andrea Gamarnick, Phd、National Council of Scientific and Technical Research, Argentina
  • 学习椅:Ana Maria Gomez Saldaño, MD MG、Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
  • 学习椅:Lorena Luna、Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
  • 学习椅:Julieta Salto、Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
  • 学习椅:Magdalena Wagner Manslau、Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
  • 研究主任:Fernan Quiroz, MD MG、Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年12月2日

初级完成 (实际的)

2021年8月20日

研究完成 (实际的)

2021年8月20日

研究注册日期

首次提交

2020年12月13日

首先提交符合 QC 标准的

2020年12月16日

首次发布 (实际的)

2020年12月17日

研究记录更新

最后更新发布 (实际的)

2021年8月25日

上次提交的符合 QC 标准的更新

2021年8月23日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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