Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 5:31 PM
Study NCT ID:
NCT04602260
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Recovery of Hospitalised Patients With COVID-19: The COREG Extension Study
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
Functional Recovery of Older Hospitalised Patients With COVID-19: a Prospective and Retrospective Cohort Study Extension to the Coronavirus Registry (COREG)
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Although there has been a rapid response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Older adults who survive the diseases are at risk of developing persistent mobility limitations due to extensive bed rest during hospitalization. For older patients and those with underlying frailty recovering from COVID-19, this could rapidly lead to significant physical deconditioning and rapid declines in mobility. Understanding the trajectory of functional recovery of older hospitalised patients with COVID-19 in the short- and long-term is critical to improving patient outcomes and informing health and rehabilitative interventions for survivors.
Detailed Description:
The coronavirus disease of 2019 (COVID-19) is an international public health challenge with far-reaching social, economic and health impacts. Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Of the 15,381 reported cases of COVID-19 in Ontario to date, approximately 22.2% (n=3,420) are aged 60-79 and 22.4% (n=3,443) are 80 and over. Although there has been a rapid and coordinated response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Anecdotally, the investigators are seeing severe declines in function, persistent symptoms, and new and worsening chronic conditions among older survivors of COVID-19. It is known that older adults who survive acute respiratory distress syndrome and associated diseases are at risk of developing persistent mobility limitations due to extensive bed rest and/or long stays in the intensive care unit (ICU) during hospitalization. Recent studies have shown that many older patients spend only 4% of their hospital stay out of bed, and each day in bed is associated with a 1-5% loss in muscle strength. For older patients and those with underlying frailty recovering from COVID-19, this could rapidly lead to significant physical deconditioning and rapid declines in mobility; with further losses in physiological reserve and resilience. Understanding the trajectory of functional recovery of older hospitalised patients with COVID-19 in the short- and long-term is critical to improving patient outcomes and informing health and rehabilitative interventions for survivors.
This study is an extension of the Coronavirus (COVID-19) Registry (COREG) platform (PI Andrew Costa)- a unique Kitchener-Waterloo-Hamilton registry of suspected and confirmed COVID-19 hospital admissions based on (and in collaboration with) the WHO International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). The addition of a prospective cohort study extension to COREG will allow the investigators to follow-older hospitalised COVID-19 patients over the longer-term in order to gain an understanding of the trajectory of functional recovery of the disease. Combining the primary data collection with COREG will also allow the investigators to identify determinants of long-term outcomes for at-risk older adults. These data are necessary to guide the clinical care and optimal management of older patients who survive serious COVID-19 illness.
This study is an extension of the Coronavirus (COVID-19) Registry (COREG) platform (PI Andrew Costa)- a unique Kitchener-Waterloo-Hamilton registry of suspected and confirmed COVID-19 hospital admissions based on (and in collaboration with) the WHO International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). The addition of a prospective cohort study extension to COREG will allow the investigators to follow-older hospitalised COVID-19 patients over the longer-term in order to gain an understanding of the trajectory of functional recovery of the disease. Combining the primary data collection with COREG will also allow the investigators to identify determinants of long-term outcomes for at-risk older adults. These data are necessary to guide the clinical care and optimal management of older patients who survive serious COVID-19 illness.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: