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临床试验/NCT04898140
NCT04898140已完成不适用

The Evaluation of the Intensity of Cellular and Humoral Immunity to COVID-19 Causative Agent in Moscow Residents

Moscow Department of Health1 个研究点 分布在 1 个国家目标入组 5,340 人开始时间: 2020年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,340
试验地点
1
主要终点
IgM/IgG titer

研究概览

简要总结

The aim of the research is to estimate the levels of cellular and humoral immunity to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among Moscow residents over 18 years old. During the study, participants will be divided into four groups: healthy volunteers; individuals recovered from coronavirus disease 2019 (COVID-19) with different severity; individuals vaccinated against SARS-CoV-2; individuals who have had COVID-19 concomitantly with comorbidities that characterized by the impact on the immune system (tuberculosis, chronic obstructive pulmonary disease, HIV infection, hematological neoplasia). For all participants included into the study peripheral blood will be collected and the titers of SARS-CoV-2 specific immunoglobulins M (IgM) and immunoglobulins G (IgG), frequencies of the T cells specific to nucleocapsid (N), membrane (M), and spike (S) proteins of SARS-CoV-2 in peripheral blood, as well as the fractions of virus specific T helpers and cytotoxic T cells will be estimated. For smaller cohorts of the participants in all groups the antibody titers and T cell response levels will be examined in dynamics. All participants will be monitored for the incidence of primary or repeated COVID-19 for 1-2 years after inclusion in the study.

Based on the results of the study, the relationship between the formation of humoral and cellular immunity against COVID-19, the duration of these types of immunity, as well as their individual contribution to protection against primary or secondary SARS-CoV-2 infection will be analyzed. Additionally, data concerning patients recovered from COVID-19 and having concomitant diseases will provide a valuable information that may help to understand in more details the mechanisms of the development of the SARS-CoV-2 specific immune response.

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

  • residents of the Moscow city (registered in Moscow);
  • 18 years old or above;
  • signed informed consent.

排除标准

  • citizenship of a foreign state;
  • refusal to sign the informed consent.

结局指标

主要结局

IgM/IgG titer

时间窗: At the moment of inclusion and for 1-2 years after inclusion in the study.

The level of SARS-CoV-2 specific IgM/IgG antibodies in blood serum.

Peripheral blood T cells specific to different SARS-CoV-2 proteins

时间窗: At the moment of inclusion and for 1-2 years after inclusion in the study.

The number of peripheral blood T cells specific to N, M or S protein of SARS-CoV-2.

Primary or repeated COVID-19 cases

时间窗: 1-2 years after inclusion in the study.

Monitoring of the SARS-CoV-2 infection cases, severity of symptoms, outcomes and recovery period among participants included into the study.

Subpopulations of SARS-CoV-2 specific peripheral blood T lymphocytes

时间窗: At the moment of inclusion and for 1-2 years after inclusion in the study.

The number of peripheral blood T-helpers and cytotoxic T cells specific to SARS-CoV-2 coronavirus antigens.

次要结局

未报告次要终点

研究者

发起方
Moscow Department of Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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