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OpenTrials
Completed

NCT Number: NCT04524520

COVID19-OR (SARS-CoV-2): Observation,Risk & Recovery

A novel coronavirus, designated corona virus disease 2019 (COVID-19) has resulted in a Pandemic at the time of writing (27th April) the reported number of confirmed cases exceeding 3 million and over 200000 associated deaths.

The burden on global critical care has been considerable. As of 24th April there have been 8752 UK critical care admissions with services under considerable strain, and a mortality rate over 50%. Survivors of critical illness will require significant input.

This study will perform mixed methods to provide rich data on risk stratification and recovery from critical illness. Recovery from a novel disease requires documenting and the study reports physical and psychological changes following hospital discharge in survivors. In addition qualitative interviews are being conducted with patients who have survived and been discharged from critical care along with their relatives and treating professionals, to better understand their needs during recovery.

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Key information

Conditions

Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Luke Hodgson

Worthing, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults ≥18 years admitted to ICU with SARS-CoV-2 and survived
  • Relatives or friends and professionals involved in the care of these patients.

Exclusion criteria

  • Patients <18 years;
  • Patients with a negative test for SARS-CoV-2 or patients not tested due to absence of symptoms;

Treatment and study plan

Primary outcomes

  1. Physical

    Time frame: through study completion , an average of 1 year

    Chelsea critical care physical assessment tool

  2. Physical

    Time frame: through study completion , an average of 1 year

    Incremental Shuttle Walk Test (ISWT)

  3. Physical

    Time frame: through study completion , an average of 1 year

    1- minute Sit to Stand, Grip strength

  4. Health Related Quality of life

    Time frame: at 3 months

    Short Form Survey on health related quality of life (SF-12). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. Higher scores indicate better outcome.

  5. Health Related Quality of life

    Time frame: at 1 year

    Short Form Survey on health related quality of life (SF-36). Scores can range from 0 to 100 and a higher score indicates better outcome.

  6. Psychological

    Time frame: through study completion , an average of 1 year

    Depression Test Questionnaire (PHQ-9). Scores range from 1 to 27 and higher scores indicate worse outcome.

  7. Psychological

    Time frame: through study completion , an average of 1 year

    Anxiety Test Questionnaire (GAD-7). Scores range from 0 to 21 and higher scores indicates worse outcome.

  8. Psychological

    Time frame: through study completion , an average of 1 year

    Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30 and higher scores indicate a better outcome.

  9. Psychological

    Time frame: at 1 year

    Post-traumatic stress disorder (PTSD) Trauma Screening (TSQ). A screening tool with 10 items. If 6 items are endorsed then the outcome is 'positive' for PTSD.

Secondary outcomes

  1. risk stratification

    Time frame: through study completion and average of 1 year

    escalation to critical care (Yes/No)

  2. risk stratification

    Time frame: through study completion and average of 1 year

    mechanical ventilation (Yes/No)

  3. risk stratification

    Time frame: through study completion and average of 1 year

    critical care stay hospital stay (number of days)

Sponsors and collaborators

Lead sponsor

Western Sussex Hospitals NHS Trust

Other

Registry information

Official study title

COVID19-OR (SARS-CoV-2):Observation, Risk & Recovery. An Observational Study Exploring Risk Assessment and Recovery From COVID-19 (SARS-CoV-2) Infection in Hospitalised Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2020
Registry last updated
Jul 18, 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.