Antibodies Responses to SARS-CoV 2 Infection (COVID-19) in Hospitalized Patients. A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Changes in the levels of N specific antibodies in severely ill patients compared to mild cases.
研究概览
简要总结
1.5. Why this clinical study?
The prevalence of seropositivity following SARS-CoV 2 infection might have its own potential benefits in terms of predicting the end of pandemic and the validity of herd immunity. It is not clear if SARS-CoV 2 infection would have a long-lasting antibody-mediated immunity, and if the antibodies' persistence is dependent on disease severity.depends on the severity of illness. If evidence is provided about the persistence of antibodies that is reflective of the protective immune response, serodiagnosis will be an important tool to identify individuals with various risk for infection, and those who are in need of receiving the forthcoming vaccines.
The here proposed prospective clinical study will test the prevalence of seropositivity following SARS-CoV 2 infection in critically ill patients compared to those who do not require intensive care unit (ICU) admission or invasive ventilation with respect to the IgM and IgG levels.
详细描述
1.1. Prevalence of Coronavirus infection:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has caused an ongoing pandemic where the first case was reported in Wuhan china earlier in December 2019 then spread exponentially to the rest of the world.
The disease has a wide spectrum of severity where most of the cases have caused mild or no symptoms, 15-20% require hospitalization, and severe cases that need intensive care unit admission account for approximately 3-5% which varies across countries with reported mortality ranged from 30-80% for mechanically ventilated patients.
1.2. Immune response to coronavirus infection.
The immune system responds to infection with coronaviruses primary by developing humoral antibodies responses, in which S-specific and to a lesser extent N-specific antibody are typically elicited in infected individuals. Previous studies conducted during severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS) epidemics identified an S and N-specific antibodies that are elicited 2-3 weeks after infection and persisted several weeks to months. During this SARS-CoV-2 pandemic, studies have revealed evidence of seroconversion in those patients who were recovered SARS-CoV-2 infections with a variable degree of response.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Symptomatic infection with at least 2 weeks' time interval since the symptom's onset.
- •Laboratory-confirmed COVID-19 with positive SARS-CoV-2 real-time polymerase chain reaction (RT-PCR) testing of nasopharyngeal or oropharyngeal swabs.
- •Inpatients in either isolated wards or ICU.
- •Agreement for blood sampling during the course of the study.
排除标准
- •Decline consent to participate.
- •Pregnancy.
- •Asymptomatic patients, who are PCR positive during routine screening upon admission
- •Administration of immunoglobulins within the 3 proceeding months including Covid-19 convalescent plasma.
- •Patients with Don't resuscitate orders
- •Patients with terminal illnesses regardless of the severity of SARS-CoV 2 infection.
结局指标
主要结局
Changes in the levels of N specific antibodies in severely ill patients compared to mild cases.
时间窗: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infection
The measurements are dependent on epitope recognitions for synthetic, adsorbed N proteins
Changes in the levels of S specific antibodies in severely ill patients compared to mild cases.
时间窗: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infection
The measurements are dependent on epitope recognitions for synthetic, adsorbed S proteins
次要结局
- N specific binding antibodies of SARS-CoV-2(4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection)
- Neutralizing antibodies directed against S protein of SARS-CoV-2(4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection)
- S specific binding antibodies of SARS-CoV-2(4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection)
- The severity category of critically ill(Day 0, 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection)
- Alive status at 28-days(For 28 days after the onset of symptoms of SARS-Cov2 infection)
- Length of ICU(For 16 weeks after the onset of symptoms of SARS-Cov2 infection)
- Length of hospital stays(For 16 weeks after the onset of symptoms of SARS-Cov2 infection)
- Correlation between the levels of N neutralizing antibodies and disease severity(For 16 weeks after the onset of symptoms of SARS-Cov2 infection)
- Alive status at 90-day(For 90 days after the onset of symptoms of SARS-Cov2 infection)
- Correlation between the levels of S neutralizing antibodies and disease severity(For 16 weeks after the onset of symptoms of SARS-Cov2 infection)