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临床试验/NCT05827939
NCT05827939招募中不适用

Association of Phenotypic Age and Antibody Titers Among SARS-Co-V2 Infected Patients and Vaccinated Groups

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
330
试验地点
1
主要终点
SARS COVID S Ab trends among different subgroups

研究概览

简要总结

Defining the antibody response to SARS-CoV-2 will be essential for understanding disease progression, long-term immunity, and vaccine efficacy. Investigators designed a study investigating the neutralizing antibody response among post-infected and post-vaccinated individuals to determine how the spike protein neutralizing antibody correlates with natural infection and vaccination and how mutations of viral strains affect associated antibodies. New Taipei City Municipal TuCheng Hospital established a special infectious pneumonia ward in May 2021 to treat patients infected with symptomatic SARS-CoV-2 patients. During the period, 97 patients were admitted and enrolled. In light of the current timing of the pandemic, most published serological studies are predominantly cross-sectional or, at most, include a longitudinal follow-up. Cognitive function and PhenoAgeAccel will be examined for SARS-CoV-2 N and S titers decline trend analysis to correlate long-COVID brain fog or early decline of N and S antibodies.Therefore, investigators designed a three-year longitudinal study to detect patients' SARS-CoV-2 neutralizing and spike antibodies.

详细描述

Coronaviruses are a diverse group of viruses infecting many different animals, and th can cause mild to severe respiratory infections in humans. At the end of 2019, a novel coronavirus designated as SARS-CoV-2 emerged in Wuhan, China, and caused an outbreak of unusual viral pneumonia. Being highly transmissible, this novel coronavirus disease, also known as coronavirus disease 2019 (COVID-19), has spread fast worldwide. It has overwhelmingly surpassed SARS and MERS regarding both the number of infected people and the spatial range of epidemic areas. The ongoing outbreak of COVID-19 has posed an extraordinary threat to global public health.

Studies in large cohorts of SARS-CoV-2 infected individuals indicate that antibodies to the receptor-binding domain (RBD) of the viral spike glycoprotein appear within the first three weeks from symptoms onset, and IgG and/or IgA seroconversion occurs either sequentially or simultaneously with the appearance of IgM. Studies showed anti-RBD IgG in 95% of COVID-19 patients by the fourth week from symptom onset and observed that these antibodies increased throughout follow-up until the third-month post-hospital discharge. Moreover, the early presence of anti-RBD IgG and anti-spike IgA positively correlated with patient survival and reduced persistence of SARS-CoV-2 RNA in nasopharyngeal swabs, respectively. The spike glycoprotein mediates entry into target cells via the ACE2 receptor. Clinical trials with monoclonal antibodies (mAbs) against its RBD decreased viral load in patients with recently diagnosed mild/moderate COVID-19.

Furthermore, anti-spike neutralizing antibodies (nAbs) produced by COVID-19 patients can block viral infection of human cells in vitro and counter viral replication in vivo. However, the impact of nAbs on the COVID-19 course is still controversial, with some studies even suggesting either a detrimental role for nAbs in disease progression or finding no nAbs differences among hospitalized patients who subsequently experienced varying disease outcomes. Whether SARS-CoV-2 nAbs decline at a similar pace is yet to be conclusively established.

Defining the antibody response to SARS-CoV-2 will be essential for understanding disease progression, long-term immunity, and vaccine efficacy. Investigators designed a study investigating the neutralizing antibody response among post-infected and post-vaccinated individuals to determine how the spike protein neutralizing antibody correlates with natural infection and vaccination and how mutations of viral strains affect associated antibodies. New Taipei City Municipal TuCheng Hospital established a special infectious pneumonia ward in May 2021 to treat patients infected with symptomatic SARS-CoV-2 patients. During the period, 97 patients were admitted and enrolled. In light of the current timing of the pandemic, most published serological studies are predominantly cross-sectional or, at most, include a longitudinal follow-up. Cognitive function and PhenoAgeAccel will be examined for SARS-CoV-2 N and S titers decline trend analysis to correlate long-COVID brain fog or early decline of N and S antibodies.

Therefore, investigators designed a three-year longitudinal study to detect participantss' SARS-CoV-2 neutralizing and spike antibodies.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 20 yrs
  • Evidenced COVID-19 infeciton by PCR sequening or commercial IVD rapid test kits. (stratified by infection periods, before 2022 vs. in 2022)
  • Clealry understand the study protocol, blood drawing, organ function survey, phenoage and phenoageAccel exams and cognitive functional evaluation.
  • Agree with regular follow-up as the protocol designs

排除标准

  • Refuse any blood draw or follow-up schedule
  • Refuse at any time
  • The PIs judges that the patient is no longer suitable to continue the study follow-up

结局指标

主要结局

SARS COVID S Ab trends among different subgroups

时间窗: 12 month

Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups

SARS COVID N Ab trends among different subgroups

时间窗: 12 month

Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups

次要结局

  • SARS COVID N Ab trends among different baseline PhenoAge scores(12 month)
  • SARS COVID S Ab trends among different baseline PhenoAge scores(12 month)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

JENG-HOW YANG

Professor Attending Physicians

Chang Gung Memorial Hospital

研究点 (1)

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