Early in the wake of the pandemic as new epidemiological data were emerging, a major concern shared by healthcare workers (HCWs) was the potential to transmit virus without any warning signs. A critical unaddressed issue is whether early detection, especially of infection before obvious symptoms, can prevent “pre-symptomatic transmission” and stop further spread.
Sung Won Choi, MD, MS, and Muneesh Tewari, MD, PhD, who are HCWs themselves, were inspired to address this question. They designed a pilot study to recruit University of Michigan (U-M) HCWs that asks the question of whether non-invasive wearable devices, taking heart rate, body temperature, and other measurements, can pick up infection before symptoms appear. The study is focusing on U-M HCWs as they are at risk for infection due to their potential exposure to COVID-19 patients, which will allow their research team to determine the prevalence of pre-symptomatic infection in this population. As lockdown measures are eased, their work may have profound public health impact.
Participants in the study will wear underarm temperature sensors and wrist watch style sensors, and answer daily symptoms surveys through a smartphone app in order to record data on those without sign of disease.
Several times a week, U-M HCWs will also self-collect nasal swab and saliva samples for researchers to analyze for presence of virus. This is a unique aspect of the project since the investigators will be using a highly sensitive approach of digital PCR, which is important because viral loads in pre-symptomatic people could be lower than symptomatic people. If successful, this could lead to a simple, broad-scale, self-swab approach that could be done in the ease of the home.
Using these collective data, the investigators ultimately aim to better predict or detect the development of a COVID-19 infection before major symptoms are noticeable clinically – guiding individuals to self-isolate and/or seek medical attention at an earlier stage.
The study is funded by the Taubman Institute and is actively recruiting U-M HCWs.
Dr. Choi, a pediatric oncologist, is a longtime Taubman Emerging Scholar and a member of the institute’s executive committee. Dr. Tewari is an oncologist and a Taubman Scholar. Both doctors are established biomedical investigators and faculty at the U-M medical school.
The 200 study participants will be outfitted with two wearable devices for 30 days: a FitBit wristband that records heat rate, physical activity and sleep data, and an underarm TempTraq patch that monitors body temperature for signs of fever. Data will be sent to the HCW’s smartphone, along with a daily survey about their work-shift through the Roadmap 2.0 app, and any symptoms of COVID-19, including cough, shortness of breath or sore throat.
“We hope that this research will ultimately lead to a low-cost, simple approach to prevent spread of the virus by detecting infection even before symptoms, allowing self-quarantine. This approach may also be useful for seasonal infectious diseases, like the flu,” said Dr. Choi.
The investigative team will assess the relationship between the device-recorded data, nasal/saliva samples, and self-reported symptoms to better understand the prevalence of pre-symptomatic U-M HCWs. Although wearable devices are being investigated by multiple groups for detection of COVID-19 illness, the U-M team’s approach is novel because it includes collection of nasal swab and saliva specimens, enabling identification of viral infection even before symptoms or clinical diagnosis of COVID-19.
“We think that the approach we are studying in HCWs could be applied much more broadly, for monitoring a whole range of essential workers and others at high-risk of catching coronavirus. It could also be helpful for people with pre-existing health problems who are especially vulnerable should they get infected — and even potentially college students,” said Dr. Tewari.