Recovery of Patients From COVID-19 After Critical Illness

NCT ID: NCT04401254

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 536 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-07-30

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

Conditions

COVID-19; Critical Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alfred

OTHER

Sponsor Role: collaborator

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol Hodgson, PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University

Locations

Canberra Hospital

Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Concord Hospital

Concord, New South Wales, Australia

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Redcliffe Hospital

Redcliffe, Queensland, Australia

Gold Coast Hospital

Southport, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Launceston Hospital

Launceston, Tasmania, Australia

Casey Hospital

Berwick, Victoria, Australia

Box Hill Hospital (Eastern Health)

Box Hill, Victoria, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Dandenong Hospital

Dandenong, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Footscray Hospital

Footscray, Victoria, Australia

Frankston Hospital

Frankston, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Cabrini Health

Malvern, Victoria, Australia

Australian New Zealand Intensive Care Research Centre

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Alfred Hospital

Prahran, Victoria, Australia

Sunshine Hospital

St Albans, Victoria, Australia

Countries

Australia

References

Hodgson CL, Higgins AM, Bailey MJ, Mather AM, Beach L, Bellomo R, Bissett B, Boden IJ, Bradley S, Burrell A, Cooper DJ, Fulcher BJ, Haines KJ, Hodgson IT, Hopkins J, Jones AYM, Lane S, Lawrence D, van der Lee L, Liacos J, Linke NJ, Gomes LM, Nickels M, Ntoumenopoulos G, Myles PS, Patman S, Paton M, Pound G, Rai S, Rix A, Rollinson TC, Tipping CJ, Thomas P, Trapani T, Udy AA, Whitehead C, Anderson S, Neto AS; COVID-Recovery Study Investigators and the ANZICS Clinical Trials Group. Comparison of 6-Month Outcomes of Survivors of COVID-19 versus Non-COVID-19 Critical Illness. Am J Respir Crit Care Med. 2022 May 15;205(10):1159-1168. doi: 10.1164/rccm.202110-2335OC.

Reference Type: DERIVED

PMID: 35258437 (View on PubMed)

Hodgson CL, Higgins AM, Bailey MJ, Mather AM, Beach L, Bellomo R, Bissett B, Boden IJ, Bradley S, Burrell A, Cooper DJ, Fulcher BJ, Haines KJ, Hopkins J, Jones AYM, Lane S, Lawrence D, van der Lee L, Liacos J, Linke NJ, Gomes LM, Nickels M, Ntoumenopoulos G, Myles PS, Patman S, Paton M, Pound G, Rai S, Rix A, Rollinson TC, Sivasuthan J, Tipping CJ, Thomas P, Trapani T, Udy AA, Whitehead C, Hodgson IT, Anderson S, Neto AS; COVID-Recovery Study Investigators and the ANZICS Clinical Trials Group. The impact of COVID-19 critical illness on new disability, functional outcomes and return to work at 6 months: a prospective cohort study. Crit Care. 2021 Nov 8;25(1):382. doi: 10.1186/s13054-021-03794-0.

Reference Type: DERIVED

PMID: 34749756 (View on PubMed)

Other Identifiers

COVID-Recovery V1.5 9Feb2022

Identifier Type: -

Identifier Source: org_study_id