Telemedically Assisted Sampling of COVID-19 Patients - Is the Sampling Quality Sufficient: An Interventional Randomized Method Comparison Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- NP HCP vs OP+N HCP
研究概览
简要总结
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) pandemic has resulted in more than 3.8 billion registered tests, 275 million positive cases, and 5 million deaths worldwide. Early and regular testing has been an important pillar of secondary prevention since the beginning.
However, this pandemic has also fostered solutions in the form of e telemedicine with enormously increased applicability.
The question of whether telemedically supervised testing with SARS-CoV-2 Rapid Antigen Tests is non-inferior to the same tests being carried out by trained personnel in test centers is still unanswered.
With this study, the investigators aim to compare and evaluate the reliability and sampling quality of telemedically guided self-performed rapid tests for professional use compared to professional sampling by healthcare personnel.
Our hypothesis is that, applying a strict standard operating procedure (SOP, attached), guided oropharyngeal + nasal (OP+N) self-sampling (GSS) is non-inferior to nasopharyngeal (NP) or OP+N sampling performed by health care professionals (HCP), and that guided OP+N sampling is superior to unsupervised OP+N self-sampling (USS).
详细描述
BACKGROUND AND PROJECT RATIONALE
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) pandemic has resulted in more than 3.8 billion registered tests, 275 million positive cases, and 5 million deaths worldwide. Early and regular testing has been an important pillar of secondary prevention since the beginning.
However, this pandemic has also fostered solutions in the form of e telemedicine with enormously increased applicability.
Several emerging issues, such as the use of technology by older adults, the availability of high-capacity Internet access, and support for telemedicine, can be overcome in the near future to increase the benefits of telemedicine.
The question of whether telemedically supervised testing with SARS-CoV-2 Rapid Antigen Tests is non-inferior to the same tests being carried out by trained personnel in test centers is still unanswered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Our hypothesis is that, applying a strict standard operating procedure (SOP, attached), guided oropharyngeal + nasal (OP+N) self-sampling (GSS) is non-inferior to nasopharyngeal (NP) or OP+N sampling performed by health care professionals (HCP), and that guided OP+N sampling is superior to unsupervised OP+N self-sampling (USS).
After giving informed consent by signing the consent form, patients will be randomized to either OP+N GSS - or to OP+N USS.
After performing either procedure, they will continue to be sampled by HCP OP+N and HCP NP.
The outcome assessors and the investigators will be blinded to the randomization to either OP+N GSS - or to OP+N US
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
- •Written informed consent
- •Patients visiting the test-station for a SARS-CoV-2 test
- •Consent to comply with the study protocol
- •Age of 18 or older
排除标准
- •Refusal to comply with the study protocol
- •Digital illiteracy (i.e. patients who would never use telemedicine as they do not feel competent enough to use the necessary tools)
- •Not German or English speaking
- •People trained in the use of rapid diagnostic tests (HCP, biologists) will be excluded to reduce bias
结局指标
主要结局
NP HCP vs OP+N HCP
时间窗: 5 months
Concordance of positive/negative samples in antigen tests with nasopharyngeal sampling vs. oropharyngeal + nasal sampling, both performed by health care professionals
OP+N HCP vs OP+N GSS
时间窗: 5 months
Concordance of positive/negative samples in antigen tests with oropharyngeal + nasal sampling performed by health care professionals vs. oropharyngeal + nasal sampling telemedically guided self-sampling
OP+N HCP vs OP+N USS
时间窗: 5 months
Concordance of positive/negative samples in antigen tests with oropharyngeal + nasal sampling performed by health care professionals vs. unsupervised oropharyngeal + nasal self-sampling (USS)
次要结局
- Detected SARS-CoV-2 variants of concern(5 months)
- Prevalence of variants of concern(5 months)
- Travel destinations in the passed three months(5 months)
- CRF assessing basic demographics and variables of interests(5 months)
- Qualitative analysis of perceived sampling accuracy(5 months)
- Immunization status regarding previous COVID-Vaccinations or previous COVID-19 disease(s)(5 months)
- Housekeeping gene Ct comparison of oropharyngeal + nasal samples between guided self-sampling, unsupervised self-sampling, or sampling performed by health care professionals(5 months)
- ORF1ab/RdRp-, E-, N-, and S genes Ct value comparison based on sampling method between samples based on GSS, USS, or HCP(5 months)
- n of people in which a nasopharyngeal sampling is possible correctly (ratio)(5 months)
研究者
Eisenring
Principal Investigator
Teststation Praxis Dr. med Bielecki