Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,320
- 试验地点
- 1
- 主要终点
- Sensitivity, Specificity and Accuracy
研究概览
简要总结
The purpose of this study is to evaluate the performance of a non-invasive olfactory device as a rapid indicator of COVID-19 in positive subjects.
详细描述
The major hypothesis is that a quantitative and unbiased smell test will be a useful tool to identify COVID-19 positive individuals.
The study will address what fraction of outpatients truly have a loss-of-smell (including a partial loss) and is expected to outperform the current question that is used to identify COVID-19 related anosmia "Do you have a new loss of smell or taste?" (yes/no) in terms of sensitivity and specificity.
The study will address if high-risk asymptomatic people whom are SARS-CoV-2 positive have a partial (or perhaps transitory) loss of smell.
The primary objective of this study is to validate the utility (sensitivity, specificity and accuracy) of a quantitative non-biased olfactory device for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). The performance of the device will also be compared to the standard CDC patient query for 'new loss of smell or taste'.
The secondary objective is to test if SARS-CoV-2 positive 'asymptomatic' COVID-19 subjects may actually present with a mild or transitory defect in smell (hyposmia), which is revealed through our quantitative olfactory smell test.
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Have a corresponding PCR test for SARS-CoV-2 on the same day.
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Individuals with allergic to fragrances
- •History of surgery on the nose or paranasal sinuses
- •Asthmatics
- •Patients with known neurocognitive disorders: dementia, Alzheimer's disease, Parkinson's disease
- •Adults with Acute or Chronic rhinosinusitis (They will be asked if they have a 'stuffy or runny nose'; they may be included in some tests, but their analysis would be segregated as they may be false positives due to allergies or a common cold or flu)
结局指标
主要结局
Sensitivity, Specificity and Accuracy
时间窗: 24 hours
The subject's score on using the olfactory device will be compared to the PCR results (SARS-CoV-2 negative or positive) on COVID19 outpatients. As the smell test has a variable scale (0-5) the ideal cutoff will be determined to maximize these factors: * Sensitivity (Represents True Positives Divided by True Positives plus False Negatives) * Specificity (Represents True Negatives Divided by True Negatives plus False Positives) * Accuracy (Represents Sensitivity x Prevalence + Specificity x (1-Prevalence) True Positives are patients who got 3 or less correct answers on the smell test and had a positive PCR COVID test. True Negatives are patients who got 4 or 5 correct responses on the smell test and had a negative PCR COVID test. False Positives are patients who got 3 or less correct responses on the smell test and had a negative PCR COVID test. False Negatives are patients who got 4 or 5 correct responses on the smell test and had a positive PCR COVID test.
次要结局
- Asymptomatic Sensitivity, Specificity and Accuracy(24 hours)
- Repeatability(48 hours)