Respiratory DiseaseREVIVeNCT05246098
REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI
An observational study of Respiratory Disease and COVID-19, run by McMaster University at 26 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Disease, COVID-19, Viral Infection
- How many people
- 679 participants
- Where
- 26 sitesCanada
- Study dates
- 24 Aug 2022to 25 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Patients who were admitted to ICU for <24 hours
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Canada26 sites
Brantford General Hospital
Brantford, Ontario, N3R 1G9
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
University of Alberta
Edmonton, Alberta, T6G2B7
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Izaak Walton Killam Hospital for Children
Halifax, Nova Scotia, B3K 6R8
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
St. Joseph's Healthcare Intensive Care Unit
Hamilton, Ontario, L8N 4A6
McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Hôpital Hôtel-Dieu de Lévis
Lévis, Quebec, G6V 3Z1
London Health Sciences Centre
London, Ontario, N6A 5W9
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
The Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
Saskatchewan Health Authority
Regina, Saskatchewan
Hôpital Fleurimont - Sherbrooke
Sherbrooke, Quebec, J1H 5H3
Niagara Health System
St. Catharines, Ontario, L2S 0A9
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
The Hospital for Sick Children
Toronto, Ontario, M5G 1E8
Children's Hospital of Winnipeg
Winnipeg, Manitoba, R3E 0Z3
About this study
Official title: REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or Acute Respiratory Infection
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.
Read more
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
- Medical subject headings
- Respiration Disorders, COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Frailty Score (Adults)
Frailty
Measured: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
Functional Status Score (Pediatrics)
Frailty (paediatrics)
Measured: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission
Secondary outcomes (5)
Katz activities of daily living (ADL; adults)
Physical Functional
Measured: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
EQ5D-5L (EuroQoL; Adults)
Physical Functional
Measured: 6-months post ICU admission
COVID-19 Yorkshire Rehab Screen
Physical function; cognition; quality of life; disease symptoms
Measured: 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.
Measured: 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.
Measured: 6-months post PICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start24 Aug 2022
- Primary completion25 Apr 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Critical Care Trials Group
- Responsible party
- Sponsor
- Investigators
- Michelle E Kho, PT, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246098
- Sponsor's protocol ID
- REVIVe
- Acronym
- REVIVe
- Status last verified
- Oct 2026
- First submitted
- 15 Feb 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or Acute Respiratory Infection
- ClinicalTrials.gov ID
- NCT05246098
- Acronym / sponsor ID
- REVIVe / REVIVe
- Conditions
- Respiratory Disease, COVID-19, Viral Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Critical Care Trials Group
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who were admitted to ICU for <24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Frailty Score (Adults)
Time frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
Frailty
Functional Status Score (Pediatrics)
Time frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission
Frailty (paediatrics)
5 secondary outcomes
Katz activities of daily living (ADL; adults)
Time frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
EQ5D-5L (EuroQoL; Adults)
Time frame: 6-months post ICU admission
COVID-19 Yorkshire Rehab Screen
Time frame: 6-months post ICU admission
Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale
Time frame: 6-months post PICU admission
Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale
Time frame: 6-months post PICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle E Kho, PT, PhD principal investigator
McMaster University
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease and COVID-19, run by McMaster University at 26 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 9 Nov 2026.