Clinical Trials Logo

Clinical Trial Summary

The vast majority of individuals with Covid19 have mild illness that can be managed in the outpatient setting. A small but significant number of these people will deteriorate and require hospitalization. Symptoms are a poor - and possibly late - indicator for deterioration. While people who have died, and/or been cared for in the ICU or hospital have been well characterized, there remains a dearth of information about the clinical course of people in the outpatient setting. Most notably, it is not known when to escalate to hospital care. The consequence of non-escalation when needed is significant patient morbidity and mortality, of escalation when not needed is unnecessarily overwhelmed hospitals. Technologies for clinical management and early diagnostics for severe Covid19 infection will address this challenge. The research goal of this study is to use real-time remote patient monitoring to detect which patients with Covid19 are at risk of deterioration to bring to hospital, while at the same ensuring the worried will receive reassurance so they stay at home. The clinical goal is to help clinicians provide excellent care using ubiquitous mobile phones.


Clinical Trial Description

People with COVID infection recovering at home or in long-term care are at high risk of hospitalization and death, a reservoir of the disease, and the source of any second wave. Three important gaps still besiege their well-being and, consequently, the well-being of all of us. First, we cannot yet accurately predict the approximately 10% who deteriorate and need hospitalization. Deterioration happens quick and without warning. Delayed detection of deterioration worsens patient outcomes. Second, COVID patients feel terrified and alone. This leads them to come to EDs when not indicated, to have poor mental health and to risk violating physical distancing rules. Third, the health of people with COVID cannot be improved without having a means of studying and understanding what they are going through. None of these gaps are being filled by public health. It is imperative that Ontario have an effective and safe outpatient care and research strategy for people with COVID isolated at home and in long term care to survive this COVID pandemic. The investigators are building a mobile smartwatch/smartphone application to create a scalable safe virtual system that meets the care needs of COVID patients at home and in long term care (including reassurance when they are doing well), that uses continuous symptom, heart rate, respiratory rate, cough and other monitoring to predict who needs to go to hospital in real time and that provides a research platform to learn how to further improve and preserve their health. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04453774
Study type Interventional
Source University Health Network, Toronto
Contact
Status Active, not recruiting
Phase N/A
Start date November 1, 2020
Completion date October 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT05065827 - Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
Recruiting NCT05359770 - Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19 N/A
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Not yet recruiting NCT06025812 - Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) N/A
Recruiting NCT05289115 - Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS N/A
Enrolling by invitation NCT04779138 - Increasing Vaccine Uptake in Underresourced Public Housing Areas N/A
Completed NCT04953078 - A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19 Phase 1
Not yet recruiting NCT05868239 - Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04572399 - UVA Light Device to Treat COVID-19 N/A
Recruiting NCT04610567 - Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19) Phase 1/Phase 2
Completed NCT04551911 - Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 Phase 2
Recruiting NCT04772170 - Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Recruiting NCT04581954 - Inflammatory Signal Inhibitors for COVID-19 (MATIS) Phase 1/Phase 2
Completed NCT04405934 - COG-UK Project Hospital-Onset COVID-19 Infections Study N/A
Enrolling by invitation NCT04484025 - SPI-1005 Treatment in Moderate COVID-19 Patients Phase 2
Completed NCT05572840 - Wear Your Mask, Wash Your Hands, Don't Get COVID-19 N/A
Withdrawn NCT04838847 - A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19 Phase 3