Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs.
研究概览
简要总结
It is a single-center, non-profit experimental study, intended to evaluate the viral load of SARS COV 2 in nasal and oral samples of positive subjects to evaluate any variation and understand which is the most suitable site for carrying out the swab.
详细描述
Experimental study on de-identified, biological samples (nasal and buccal swab).
The study will be performed on patients admitted to IRCCS Sacro Cuore Don Calabria Hospital or health care workers or their family members, who tested positive for SARS-CoV-2 by either a molecular or antigen test, performed on nasopharyngeal swab, according to current diagnostics.
Among the family members, also children >4 years old will be included. The reason for including children and young subjects is based on data indicating that they seems to be highly sensitive to Omicron infection and that their vaccination status could influence viral load. The nose and mouth swab are poor invasive and they could be well tolerated also by children.
Whinin 7 days from diagnosis, the subjects will be requested to sample another two specimens i.e. nasal swab and mouth swab, that will be tested for the presence of SARS-CoV-2 RNA. Results, expressed as cycle threshold will be then compared to analyze viral loads from the two different sites.
Moreover, an aliquot will be retro-transcribed into cDNA and sequenced by Next Generation Sequencing (NGS) to obtain the virus entire genome sequence or evaluated by RT-PCR for variant determination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients admitted to IRCCS Sacro Cuore Don Calabria Hospital or health care workers or their family members. Among the family members, also children >4 years old will be included.
- •Subjects verified as positive to SARS-CoV-2 according to either a molecular or antigen test, performed on nasopharyngeal swab, according to current diagnostics.
- •Subjects who will accept to participate to the study and will sign the informed consent.
排除标准
- •lack of any needed data or inform consent
结局指标
主要结局
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs.
时间窗: 2 months
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs.
- RT-PCR analysis results for subgenomics
时间窗: 2 months
\- RT-PCR analysis results for subgenomics
- Droplet digital PCR (ddPCR) results for SARS-CoV-2
时间窗: 2 months
\- Droplet digital PCR (ddPCR) results for SARS-CoV-2
- NGS or RT-PCR results for genomic lineages or variant identification.
时间窗: 2 months
\- NGS or RT-PCR results for genomic lineages or variant identification.
次要结局
- SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs in relationship to the sampling site, to the viral characterization and to the time from diagnosis.(2 months)