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REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI

Study acronym: REVIVe
StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Final enrollment: 679 participants (planned 900) · Study sites: 28 to 26 · Primary completion date changed from estimate of Mar 31, 2025 to Apr 25, 2025 · 3 more Show 6 more changesShow less
    • Final enrollment: 679 participants (planned 900)
    • Study sites: 28 to 26
    • Primary completion date changed from estimate of Mar 31, 2025 to Apr 25, 2025
    • Study completion date changed from estimate of Oct 1, 2025 to Oct 25, 2025
    • Secondary endpoints: details revised at 2 of 5 entries
    • Eligibility criteria expanded, about 2 words
  2. Minor Study sites: 24 to 28 Start date: Sep 15, 2022 to Aug 24, 2022v7 Show 1 more changeShow less
    • Start date: Sep 15, 2022 to Aug 24, 2022
  3. Minor Study sites: 3 to 24v6
  4. Minor Site details revised at 1 of 3 sitesv5
  5. Notable Primary completion date: Mar 31, 2024 to Mar 31, 2025 Completion date: Oct 1, 2024 to Oct 1, 2025 · Eligibility criteria shortened, about 10 words · Secondary endpoints: details revised at 5 of 5 entries · 1 morev4 Show 4 more changesShow less
    • Completion date: Oct 1, 2024 to Oct 1, 2025
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 1, 2022 to Sep 15, 2022 · Site details revised at 3 of 3 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Apr 1, 2022 to Sep 15, 2022
    • Site details revised at 3 of 3 sites
  2. Notable Primary endpoints revised (2) Eligibility criteria expanded, about 7 words · Secondary endpoints revised (5)v2 Show 2 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05246098
Lead Sponsor McMaster University
Collaborators: Canadian Institutes of Health Research (CIHR), Canadian Critical Care Trials Group
Conditions Respiratory Disease, COVID-19, Viral Infection
Enrollment 679 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov