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临床试验/NCT04348422
NCT04348422已完成不适用

Evaluation of the Immune Response in Symptomatic and Asymptomatic Patients' Diagnosed Witih COVID-19

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
214
试验地点
2
主要终点
Proportion of symptomatic patients with immune response (IgM/IgG/IgA)

研究概览

简要总结

The 2019-20 coronavirus disease, caused by COVID-19, is an ongoing pandemic. The measures in which public health officials quarantine confirmed and isolate symptomatic cases in order to reduce the spread COVID-19 is the common practice used in most countries. However, a significant question remains in regards to the asymptomatically infected individuals, which may propagate the virus and impede infection control. The other question to consider is whether these asymptomatic carriers develop an immune response or continue viral shedding. The purpose of the current study is the evaluate the immune response, i.e developing anti-SARS-CoV-2 antibodies in the asymptomatic cases, in a household study design.

We plan to evaluate over 1000 patients with positive COVID-19 results and their households.

详细描述

The 2019-20 coronavirus disease, caused by COVID-19, is an ongoing pandemic. The outbreak started in Wuhan, Hubei province, China, in December 2019 and the World Health Organization (WHO) recognized it as a pandemic on 11 March 2020. Up to Apr 9. 2020 there are more than 1.4 million confirmed cases, and over 82,000 deaths 1. In Israel, COVID-19 was confirmed in more 9,000 cases and took the life of 70 victims (09.04.2020) .

With the extensive outbreak of COVID-19, a mass of studies with a large population have been reported. Wu et al. found that the mean R0 of COVID-19 was approximately 2.68(95% CI: 2.47-2.86) . The measures in which public health officials quarantine confirmed and isolate symptomatic cases in order to reduce the spread COVID-19 is the common practice used in most countries. However, a significant question remains in regards to the asymptomatically infected individuals, which may propagate the virus and impede infection control.

The problem To date, initial surveillance has focused primarily on patients with severe disease, and, as such, the full spectrum of the disease. The extent of asymptomatic disease is not clear. Mizumoto et al. mathematical model suggested 17.9-33.3% are asymptomatic carriers. The other question to consider is whether these asymptomatic carriers develop an immune response or continue viral shedding.

SARS-CoV-2, the causative viral agent of the disease COVID-19, is a coronavirus which bears the transmembrane glycoprotein spikes (S protein) typical of viruses in its clade. The spikes on SARS-CoV-2 allows the virus to enter host cells through the human receptor angiotensin converting enzyme 2 (ACE2), present in alveolar epithelial cells. These spikes are a prominent target of human immune responses and have been found to be highly immunogenic and induce antibody production. The receptor-binding domain (RBD) of the S protein is particularly targeted by neutralizing antibodies.

The diagnostic test in symptomatic patients is based on real time polymerase chain reaction (RT-PCR), which tests the existence of specific COVID-19 genes in the sample. However, there are growing numbers of reports of false negative results due to improper sample collection, low viral load or technical instability of the PCR.

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

  • Positive COVID-19 RT-PCR to the subject or his/her household.
  • Over 18 years old
  • Ability to sign an informed consent

排除标准

  • Inability to sign an informed consent
  • Pregnancy

研究组 & 干预措施

Symptomatic

COVID-19 RT-PCR positive patients with reported symptoms

干预措施: COVID-19 RT-PCR (Diagnostic Test)

Symptomatic

COVID-19 RT-PCR positive patients with reported symptoms

干预措施: COVID-19 Serology (Diagnostic Test)

Symptomatic

COVID-19 RT-PCR positive patients with reported symptoms

干预措施: Symptoms questionnare (Other)

Asymptomatic

COVID-19 RT-PCR positive patients without presenting any symptoms

干预措施: COVID-19 RT-PCR (Diagnostic Test)

Asymptomatic

COVID-19 RT-PCR positive patients without presenting any symptoms

干预措施: COVID-19 Serology (Diagnostic Test)

Asymptomatic

COVID-19 RT-PCR positive patients without presenting any symptoms

干预措施: Symptoms questionnare (Other)

结局指标

主要结局

Proportion of symptomatic patients with immune response (IgM/IgG/IgA)

时间窗: 100 days

The percentage of symptomatic patients who developed either IgM/IgG/IgA response within 100 days from COVID-19 Infection

Proportion of Asymptomatic patients with immune response (IgM/IgG/IgA)

时间窗: 100 days

The percentage of Asymptomatic patients who developed either IgM/IgG/IgA response within 100 days from COVID-19 Infection

次要结局

  • Proportion of symptomatic patients with immune response (IgM/IgG/IgA)- long term(1 year)
  • Time to IgM(Evaluated within a 100 days followup)
  • Time to IgG(Evaluated within a 100 days followup)
  • Time to IgA(Evaluated within a 100 days followup)
  • Serology kits inter-observer agreement(Evaluated within a 100 days followup)
  • Proportion of Asymptomatic patients with immune response (IgM/IgG/IgA) -long term(1 year)

研究者

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

Shay Efrati

Head of Research and Development Unit, Shamir Medical Center

Assaf-Harofeh Medical Center

研究点 (2)

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