An observational study in Respiratory Disease, COVID-19 and Viral Infection, sponsored by McMaster University. Completed at 26 sites in Canada. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by McMaster University · Observational
Background: Many adults and some children with COVID-19 or acute respiratory infection become critically ill and need advanced life support in the Intensive Care Unit (ICU). Frailty is a medical condition of reduced function and health. Adults with frailty have a lower chance of surviving critical illness. The investigators are still learning about critically ill adults with COVID-19 or acute respiratory infection, and do not have much information on how frailty affects outcomes in critically ill children, with or without COVID-19 or acute respiratory infection. Rehabilitation can help survivors of COVID-19 or acute respiratory infection by improving strength and improve quality of life (QOL).
Objectives: The main goal of this research study is to see if patients with frailty have a lower chance of surviving COVID-19 or acute respiratory infection critical illness and more health problems after survival than patients without frailty. The investigators will also study the types of rehabilitation received by patients with COVID-19 or acute respiratory infection.
Methods: The investigators will include adults and children with COVID-19 or acute respiratory infection who are admitted to the ICUs that participate in the study. The investigators will gather data about each patient, including before and during their illness.
Outcomes: The investigators will collect level of frailty, function, and types of therapy, or rehabilitation received by patients. In adults, the investigators are most interested in learning if frailty influences mortality, or death. In children, the investigators are most interested in whether children with COVID-19 or acute respiratory infection critical illness are more likely to develop frailty. The investigators will also study post-hospital discharge location in survivors (e.g., home, rehabilitation).
Relevance: The COVID-19 pandemic is a global public health crisis. It is critical to understand how COVID-19 and other acute respiratory infection critical illness affects groups of people who are at higher risk, and the impact on outcomes that are important to patients, like functioning and QOL. The results will help policy makers plan post-hospital services for survivors, help healthcare workers understand the importance of rehabilitation practice for patients with COVID-19 or acute respiratory infection, and help researchers develop treatments to improve QOL after COVID-19 or acute respiratory infection.
520 studies on the registry are indexed under Respiration Disorders; 99 are open to participants now.
This study's enrollment of 679 is above the median of 235 across 208 observational studies indexed under Respiration Disorders.
Browse Respiration Disorders studies →McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult and pediatric survivors of COVID-19 or acute respiratory infection admitted to participating intensive care units (ICUs) and PICUs. The investigators define children as less than, and adults as greater than or equal to, 18 years old, respectively. The investigators will include adults and pediatrics with a confirmed diagnosis of COVID-19, pediatric patients with MIS-C, and adults and pediatrics with suspected or proven acute respiratory infection with onset within 14 days of ICU/PICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high flow oxygen therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult survivors of COVID-19 or acute respiratory infection admitted to participating ICUs. Adults are defined as greater than or equal to, 18 years old. We will include adults with a confirmed diagnosis of COVID-19 or those with suspected or proven acute respiratory infection with onset within 14 days of ICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high-flow oxygen therapy.
Pediatric survivors of COVID-19, MIS-C, or acute respiratory infection admitted to participating pediatric intensive care units (PICUs). The investigators define children as less than 18 years old. We will include pediatric patients with COVID-19, those with multi-system inflammatory syndrome in children (MIS-C), and those with suspected or proven acute respiratory infection with onset within 14 days of ICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high-flow oxygen therapy.
Clinical Frailty Score (Adults)
Frailty
Time frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
Functional Status Score (Pediatrics)
Frailty (paediatrics)
Time frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission
Katz activities of daily living (ADL; adults)
Physical Functional
Time frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
EQ5D-5L (EuroQoL; Adults)
Physical Functional
Time frame: 6-months post ICU admission
COVID-19 Yorkshire Rehab Screen
Physical function; cognition; quality of life; disease symptoms
Time frame: 6-months post ICU admission
Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale
Quality of Life; Each item is measured on a 5 point Likert scale with 0 indicating never and 4 indicating almost always.The Likert scores are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 3=25, and 4=0. A higher score indicates better health-related quality of life.
Time frame: 6-months post PICU admission
Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale
Quality of Life; Each item is measured on a 5 point Likert scale with 0 indicating never and 4 indicating almost always.The Likert scores are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 3=25, and 4=0. A higher score indicates better health-related quality of life.
Time frame: 6-months post PICU admission
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2022 to primary completion in Apr 2025, 32 months.
Of 88 non-industry observational studies under Respiration Disorders, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's 32 months is above that.
Counting every sponsor, half of 108 studies reached it within 22 months; a quarter within 10 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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