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临床试验/NCT04673279
NCT04673279已完成不适用

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

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2020年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
14 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • deny consent

结局指标

主要结局

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

时间窗: 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

次要结局

  • to estimate the proportion of people with positive IgG antibodies for dengue(up to 20 weeks)

研究者

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

ALICIA MISTCHENKO

principal investigator

Hospital Italiano de Buenos Aires

研究点 (1)

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