Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2).

ABSTRACT

BACKGROUND: The outbreak of SARS-CoV-2 (coronavirus, COVID-19), declared a pandemic by the World Health Organization (WHO), is a global health problem with ever-increasing attributed deaths. Vital sign trends are routinely used to monitor patients with changes in these parameters often preceding an adverse event. Wearable sensors can measure vital signs continuously (e.g. heart rate, respiratory rate, temperature) remotely and can be utilised to recognise early clinical deterioration. METHODS: We describe the protocol for a pilot, proof-of-concept, observational study to be conducted in an engineered hotel near London airports, UK. The study is set to continue for the duration of the pandemic. Individuals arriving to London with mild symptoms suggestive of COVID-19 or returning from high-risk areas requiring quarantine, as recommended by the Public Health England, or healthcare professionals with symptoms suggestive of COVID-19 unable to isolate at home will be eligible for a wearable patch to be applied for the duration of their stay. Notifications will be generated should deterioration be detected through the sensor and displayed on a central monitoring hub viewed by nursing staff, allowing for trend deterioration to be noted. The primary objective is to determine the feasibility of remote monitoring systems in detecting clinical deterioration for quarantined individuals in a hotel. DISCUSSION: This trial should prove the feasibility of a rapidly implemented model of healthcare delivery through remote monitoring during a global pandemic at a hotel, acting as an extension to a healthcare trust. Potential benefits would include reducing infection risk of COVID-19 to healthcare staff, with earlier recognition of clinical deterioration through ambulatory, continuous, remote monitoring using a discrete wearable sensor. We hope our results can power future, robust randomised trials. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04337489 .