A Pilot Study for the Collection Of Vocalized, Individual Digital Cough Sound Recordings to Screen for COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Collection of cough sound recordings and self-reported symptoms from a minimum of 100 COVID-19 positive participants as identified by rt-qPCR.
研究概览
简要总结
Decentralized clinical study designed to collect cough sounds and self-reported symptoms alongside a COVID-19 realtime quantitative polymerase chain reaction (rt-qPCR) test. The aim of the data collection is to develop a safe and effective cough based digital screening tool for COVID-19.
详细描述
This study is designed to be administered in a hybrid manner to collect cough sample recordings in association with self-reported symptoms and a COVID-19 rt-qPCR test to investigate whether algorithms can be developed to distinguish COVID-19 positive patients from COVID-19 negative patients using a combination of cough sounds with or without patient-reported symptoms.
Participants will be recruited into two arms with participants entering each arm undergoing the following procedures:
Arm 1 Participants will be recruited into Arm 1 through online marketing campaigns targeted to areas of high COVID-19 incidence as reported by the CDC. Participant recruitment campaign material will direct participants to a Study Landing Page (webpage) (See COVID Cough Study Landing Page - Wire Frame document) that will provide the high-level details of the study including the inclusion/exclusion criteria.
If participants choose to undergo the informed consent process and enroll onto the study, they will download the smartphone-based Study Research App that will virtually perform the following:
- Informed consent completion
- Inclusion/exclusion screening question
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be aged 21 years and older;
- •be a resident of the USA;
- •have a personal (i.e., not shared) iPhone 6s or newer running iOS 14 or later;
- •be able to read and understand English;
- •be able to provide informed consent;
- •be able to provide at least 5 coughs (voluntary and/or spontaneous);
- •if enrolling online in Arm 1, the participant must be unvaccinated against COVID-19 (have not received one or more doses of a COVID-19 vaccine at any time before study enrolment)
排除标准
- •have one or more medical contraindication to voluntary cough, including the following:
- •Severe respiratory distress;
- •History of pneumothorax;
- •Eye, chest, or abdominal surgery within 3 months of enrolling for the study; or
- •Hemoptysis (coughing up of blood) within 1 month of enrolling for the study;
结局指标
主要结局
Collection of cough sound recordings and self-reported symptoms from a minimum of 100 COVID-19 positive participants as identified by rt-qPCR.
时间窗: 3 months
Cough sound recordings and symptoms from COVID-positive patients
Development of an algorithm that uses a combination of cough sounds and self-reported symptoms that is capable of distinguishing between COVID-19 positive and COVID-19 negative participants.
时间窗: 3 months
Cough sound algorithm that distinguishes with COVID-19 positive and negative cough sounds.
次要结局
- Development of an algorithm that uses cough sounds that is capable of distinguishing between COVID-19 positive and COVID-19 negative participants.(3 months)