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Recovery of Patients From COVID-19 After Critical Illness

The Coronavirus Disease 2019 - Recovery Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04401254
Enrollment
536
Registered
2020-05-26
Start date
2020-07-01
Completion date
2022-07-30
Last updated
2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Critical Illness

Keywords

recovery

Brief summary

Patients who are critically ill with COVID-19 requiring life support in an intensive care unit (ICU) have increased risk of morbidity and mortality. Currently the ICU community does not know what effect the disease, the ICU admission, physiotherapy interventions and life support have on their long-term quality of life and whether they can return to their pre-illness level of function following ICU. COVID-Recovery will describe the physiotherapy interventions delivered to critically ill patients with COVID-19. In survivors, COVID-Recovery will utilise telephone follow-up of ICU survivors to assess disability-free survival and quality of life at 6 months after ICU admission. Additionally, COVID-Recovery will identify if there are predictors of disability-free survival. COVID-Recovery will aim to select up to 300 patients diagnosed with COVID-19 from ICUs in Australia. If they survive to hospital discharge, patients will be invited to receive a telephone questionnaire at 6 months after the ICU admission that aims to assess their long-term outcomes, including physical, cognitive and emotional function, quality of life, and whether they have been able to return to work following ICU discharge. To describe the experience of critical illness in survivors of COVID-19 and their family members. To explore and describe functional recovery, respiratory system function and respiratory health morbidity up to 6 months after ICU admission in persistently critically ill adults with COVID-19

Interventions

None listed

Sponsors

The Alfred
CollaboratorOTHER
Australian and New Zealand Intensive Care Research Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. COVID-19 patients who have been admitted to ICU for \> 24 hours 2. Patients aged over 17 years Persistent critical illness cohort 1. As above 2. An ICU admission of at least 10 consecutive days

Exclusion criteria

* Previous enrolment in this study in a prior ICU admission

Design outcomes

Primary

MeasureTime frameDescription
Disability-free survival6 monthsa composite measure of WHODAS 2.0 - 12 level and hospital survival
Physiotherapy interventionDuring the ICU stay until 3 monthsThe physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes

Secondary

MeasureTime frameDescription
Cognitive function6 monthsMontreal Cognitive Assessment Blind
Anxiety and depression6 monthsHospital Anxiety and Depression Scale
Screening for post-traumatic distress6 monthsImpact of Events Scale Revised
Work Status6 monthsWHODAS 2.0
Health status6 monthsHealth related quality of life measured with EQ5D-5L score from 0 to 100
The reported barriers to delivering physiotherapy interventionsDuring the ICU stay until 28 daysPhysiotherapist reported barriers to delivering the intervention
Adverse events during physiotherapy interventionsDuring the ICU stay until 28 daysAdverse events that require the intervention to be ceased for medical intervention
Phenomenological data of the patient and family experience6 monthsQualitative interviews
Proportion of patients with COVID-19 who received physiotherapy in ICUDuring the ICU stay until 28 days
Global function6 monthsWorld Health Organization Disability Assessment Schedule 2.0 12L

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026