Skip to main content
OpenTrials
Completed

NCT Number: NCT04401254

Recovery of Patients From COVID-19 After Critical Illness

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Canberra Hospital, Garran, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Previous enrolment in this study in a prior ICU admission

Treatment and study plan

Primary outcomes

  1. Disability-free survival

    Time frame: 6 months

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

  2. Physiotherapy intervention

    Time frame: During the ICU stay until 3 months

    The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes

Secondary outcomes

  1. Health status

    Time frame: 6 months

    Health related quality of life measured with EQ5D-5L score from 0 to 100

  2. Global function

    Time frame: 6 months

    World Health Organization Disability Assessment Schedule 2.0 12L

  3. Cognitive function

    Time frame: 6 months

    Montreal Cognitive Assessment Blind

  4. Anxiety and depression

    Time frame: 6 months

    Hospital Anxiety and Depression Scale

  5. Screening for post-traumatic distress

    Time frame: 6 months

    Impact of Events Scale Revised

  6. Work Status

    Time frame: 6 months

    WHODAS 2.0

  7. Proportion of patients with COVID-19 who received physiotherapy in ICU

    Time frame: During the ICU stay until 28 days

  8. The reported barriers to delivering physiotherapy interventions

    Time frame: During the ICU stay until 28 days

    Physiotherapist reported barriers to delivering the intervention

  9. Adverse events during physiotherapy interventions

    Time frame: During the ICU stay until 28 days

    Adverse events that require the intervention to be ceased for medical intervention

  10. Phenomenological data of the patient and family experience

    Time frame: 6 months

    Qualitative interviews

  11. Global function

    Time frame: 6 months

    Global Rating of Change

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • The Alfred

Registry information

Official study title

The Coronavirus Disease 2019 - Recovery Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 26, 2020
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.