NCT04401254

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

May 7, 2020

Last Update Submit

September 26, 2022

Conditions

Keywords

recovery

Outcome Measures

Primary Outcomes (2)

  • Disability-free survival

    a composite measure of WHODAS 2.0 - 12 level and hospital survival

    6 months

  • 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 Outcomes (11)

  • Health status

    6 months

  • Global function

    6 months

  • Cognitive function

    6 months

  • Anxiety and depression

    6 months

  • Screening for post-traumatic distress

    6 months

  • +6 more secondary outcomes

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients with COVID-19 admitted to an intensive care unit

You may qualify if:

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

You may not qualify if:

  • Previous enrolment in this study in a prior ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Concord Hospital

Concord, New South Wales, 2139, Australia

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Redcliffe Hospital

Redcliffe, Queensland, 4020, Australia

Location

Gold Coast Hospital

Southport, Queensland, 4215, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Launceston Hospital

Launceston, Tasmania, 7250, Australia

Location

Casey Hospital

Berwick, Victoria, 3806, Australia

Location

Box Hill Hospital (Eastern Health)

Box Hill, Victoria, 3128, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Dandenong Hospital

Dandenong, Victoria, 3175, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Footscray Hospital

Footscray, Victoria, 3011, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Cabrini Health

Malvern, Victoria, 3144, Australia

Location

Australian New Zealand Intensive Care Research Centre

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Alfred Hospital

Prahran, Victoria, 3004, Australia

Location

Sunshine Hospital

St Albans, Victoria, 3021, Australia

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

COVID-19Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carol Hodgson, PhD

    Monash University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 26, 2020

Study Start

July 1, 2020

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

IPD will be shared if approved by the steering committee and with ethical approvals.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
12 months after completion of the study for 12 months
Access Criteria
Email the Chief Investigator

Locations