Recruiting

Frailty & COVID-19

Sponsor:

McMaster University

Code:

NCT05246098

Conditions

Respiratory Disease

COVID-19

Viral Infection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Respiratory Disease

COVID-19

Viral Infection

Study ID

NCT05246098

Start date

Aug 24, 2022

Status verified date

Nov, 2024

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who were admitted to ICU for <24 hours

Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

Adults

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.

Pediatrics

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.

Primary outcome measure

  • Clinical Frailty Score (Adults) [ Time Frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission ]
  • Functional Status Score (Pediatrics) [ Time Frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G2B7

Contacts

Oleksa Rewa, MD, MSc

780.231.3280rewa@ualberta.ca

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

Izaak Walton Killam Hospital for Children

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Brantford General Hospital

Recruiting

Brantford, Ontario, Canada, N3R 1G9

Contacts

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

St. Joseph's Healthcare Intensive Care Unit

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Michelle Kho, PT, PhD

khome@mcmaster.ca

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Contacts

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Andrew Seely

aseely@toh.ca

Niagara Health System

Recruiting

St. Catharines, Ontario, Canada, L2S 0A9

Contacts

Sunnybrook Hospital

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Hôpital Hôtel-Dieu de Lévis

Recruiting

Lévis, Quebec, Canada, G6V 3Z1

Contacts

Centre hospitalier de l'Université de Montréal

Recruiting

Montréal, Quebec, Canada, H2X 3E4

Contacts

Hôpital du Sacré-Cœur de Montréal

Recruiting

Montréal, Quebec, Canada, H4J 1C5

Contacts

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Recruiting

Quebec City, Quebec, Canada, G1V 4G5

Contacts

Hôpital Fleurimont - Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5H3

Contacts

Saskatchewan Health Authority

Recruiting

Regina, Saskatchewan, Canada

Contacts

More Information

Sponsor

McMaster University

Last update posted

Nov 6, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-11-06.