Clinical, Virological, Serological and Immunological Characteristics During and Following COVID-19 Hospitalization: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Neutralizing Antibody Titer - Day 0
研究概览
简要总结
Assessment of the association between the severity of COVID-19 and SARS-CoV-2 NAb titers levels for up to six months following primary infection using a live virus NAb assay. Description of SARS-CoV-2 viral shedding and infectiousness during the first 30 days after infection in a group of unvaccinated hospitalized patients.
详细描述
The studys primary aim is to assess clinical factors, such as disease severity, associated with neutralizing antibody (NAb) production. Furthermore, the study aims to assess the length of SARS-CoV-2 infectiousness and clinical factors associated with viral load.
Patients 18 years or older hospitalized at Copenhagen University Hospital at North Zealand, Copenhagen, Denmark, May 24th,2020 - May 5th, 2021, were routinely screened for COVID-19 by diagnostic oropharyngeal or tracheal RT-PCR samples taken during admission. Patients with a positive SARS-CoV-2 PCR within 48 hours from hospital admission were offered inclusion, if COVID-19 pneumonia was confirmed.
The following were retrieved from patients' electronic records: comorbidities (Charlson Comorbidity Index),vital signs (Early Warning Score), immunocompromised status, time from symptom onset to admission, oxygen treatment, pharmacological treatment, admission length, death and bacterial co-infection.
Paired oropharyngeal swabs and serum samples were collected at inclusion (day 0), days 3, 7, 10, 14, 17, 24, and 30. Serum samples were, if possible, also collected after three and six months. Follow-up time was six months.
RT-qPCR analysis targeted the SARS-CoV-2 RNA-dependent-RNA-polymerase (RdRp)-helicase gene region and two samples with known viral load were included in each PCR-run for quantification of patient samples. Virus was cultured in African green monkey cells (VERO-E6) with incubation for 3 - 4 days and daily microscopic inspection for cytopathogenic effect (CPE). A total of three passages were made before the the virus was interpreted as non-replicant. Cells with CPE were confirmed by RT-qPCR.
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
- 否
入选标准
- •positive SARS-CoV-2 specimen from upper or lower respiratory tracts (virological criteria)
- •consolidations on the chest X-ray described by a radiologist, treating physician or a physician from the study group (radiological criteria)
- •the presence of one or more of the following: fever (temperature ≥38.0°C), new-onset cough, pleuritic chest pain, dyspnea or altered breath sounds on auscultation (clinical criteria)
排除标准
- •cognitive impairment prohibiting giving informed consent to participation
- •by December 14th, 2020, and onwards patients if the time since symptom onset was > seven days at the time of inclusion
结局指标
主要结局
Neutralizing Antibody Titer - Day 0
时间窗: Day 0
Baseline Log10 Spike protein neutralizing antibody titer
Change from baseline in Neutralizing Antibody Titer - Day 30
时间窗: Day 30
Log10 Spike protein neutralizing antibody titer
Viral culturing - Day 0
时间窗: Day 0
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 14
时间窗: Day 14
Number of successful viral culturing attempts (SARS-CoV-2)
Change from baseline in Neutralizing Antibody Titer - Day 90
时间窗: Day 90
Log10 Spike protein neutralizing antibody titer
Viral culturing - Day 3
时间窗: Day 3
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 24
时间窗: Day 24
Number of successful viral culturing attempts (SARS-CoV-2)
Change from baseline in Neutralizing Antibody Titer- Day 180
时间窗: Day 180
Log10 Spike protein neutralizing antibody titer
Viral culturing - Day 10
时间窗: Day 10
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 30
时间窗: Day 30
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 17
时间窗: Day 17
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 7
时间窗: Day 7
Number of successful viral culturing attempts (SARS-CoV-2)
次要结局
- Change from Baseline Viral Load - Day 14(Day 14)
- Change from Baseline Viral Load - Day 30(Day 30)
- Change from Baseline Viral Load - Day 3(Day 3)
- Change from Baseline Viral Load - Day 17(Day 17)
- Baseline Viral Load - Day 0(Day 0)
- Change from Baseline Viral Load - Day 7(Day 7)
- Change from Baseline Viral Load - Day 10(Day 10)
- Change from Baseline Viral Load - Day 24(Day 24)
