Molecular Detection of SARS-CoV-2 From Oropharyngeal Swabs Performed With or Without Specimen Collection From the Palatine Tonsils - a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- RT-PCR results
研究概览
简要总结
Citizens who undergo testing for COVID-19 at one of two Testcenters in Copenhagen Captial Region will be invited to participate in the study. The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing. The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR. The diagnostic accuracy and SARS-CoV-2 viral load will be compared. The participants will be asked to complete a questionnaire regarding their symptoms.
详细描述
We will include citizens referred for outpatient testing for COVID-19 who will be offered to participante in the study on a volunteer basis. Participants are all volunteers, who are attending the test facilities to obtain a PCR test. Participants are required to provide oral and written informed consent to participate before entering the study. The inclusion criterion is 18 years or more of age. Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients).
The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing.
The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR as usual. The diagnostic accuracy and SARS-CoV-2 viral load will be compared using independent t-test. The participants will be asked to complete a questionnaire regarding their symptoms and the number of sick days. All data will be documented on-site in a secure web database (REDCap).
The primary outcome will be reported as:
• SARS-CoV-2 RNA by RT-PCR test result (positive, negative, inconclusive)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •citizens referred for outpatient testing for COVID-19 in Valby and Hillerød COVID-19 TestCenter.
排除标准
- •Age under 18 years
- •neck breathers (tracheostomy/laryngectomy patients)
结局指标
主要结局
RT-PCR results
时间窗: Day 1
The detection rate of SARS-CoV-2 RNA
次要结局
- Sycle threshold (Ct)(Day 1)
- Participants oropharynx anatomy(Day 1)
- Test accuracy between healthcare workers(Day 1)
- Inconclusive tests(Day 1)
- Development of COVID-19 disease after testing(1 month)
- Test discomfort(Day 1)
研究者
Tobias Todsen
Consultant, Associate Prof
Rigshospitalet, Denmark
