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临床试验/NCT05274373
NCT05274373Unknown不适用

Clinical, Virological, Serological and Immunological Characteristics During and Following COVID-19 Hospitalization: a Prospective Cohort Study

Nordsjaellands Hospital1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2020年5月24日最近更新:
适应症

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

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)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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