Recovery of Patients From COVID-19 After Critical Illness

COVID-19 Clinical Trial

Official title:

The Coronavirus Disease 2019 - Recovery Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401254
• Other study ID #: COVID-Recovery V1.5 9Feb2022
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2022
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Critical Illness

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Casey Hospital	Berwick	Victoria
Australia	Box Hill Hospital (Eastern Health)	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Concord Hospital	Concord	New South Wales
Australia	Dandenong Hospital	Dandenong	Victoria
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	St Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Footscray Hospital	Footscray	Victoria
Australia	Frankston Hospital	Frankston	Victoria
Australia	Canberra Hospital	Garran	Australian Capital Territory
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	St George Hospital	Kogarah	New South Wales
Australia	Launceston Hospital	Launceston	Tasmania
Australia	Cabrini Health	Malvern	Victoria
Australia	Australian New Zealand Intensive Care Research Centre	Melbourne	Victoria
Australia	John Hunter Hospital	New Lambton Heights	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Alfred Hospital	Prahran	Victoria
Australia	Redcliffe Hospital	Redcliffe	Queensland
Australia	Royal North Shore Hospital	Saint Leonards	New South Wales
Australia	Gold Coast Hospital	Southport	Queensland
Australia	Sunshine Hospital	St Albans	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability-free survival	a composite measure of WHODAS 2.0 - 12 level and hospital survival	6 months
Primary	Physiotherapy intervention	The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes	During the ICU stay until 3 months
Secondary	Health status	Health related quality of life measured with EQ5D-5L score from 0 to 100	6 months
Secondary	Global function	World Health Organization Disability Assessment Schedule 2.0 12L	6 months
Secondary	Cognitive function	Montreal Cognitive Assessment Blind	6 months
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale	6 months
Secondary	Screening for post-traumatic distress	Impact of Events Scale Revised	6 months
Secondary	Work Status	WHODAS 2.0	6 months
Secondary	Proportion of patients with COVID-19 who received physiotherapy in ICU		During the ICU stay until 28 days
Secondary	The reported barriers to delivering physiotherapy interventions	Physiotherapist reported barriers to delivering the intervention	During the ICU stay until 28 days
Secondary	Adverse events during physiotherapy interventions	Adverse events that require the intervention to be ceased for medical intervention	During the ICU stay until 28 days
Secondary	Phenomenological data of the patient and family experience	Qualitative interviews	6 months
Secondary	Global function	Global Rating of Change	6 months