Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised PatientsNCT04524520
COVID19-OR (SARS-CoV-2): Observation,Risk & Recovery
An observational study of Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised Patients, run by Western Sussex Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised Patients
- How many people
- 194 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2020to 8 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults admitted to hospital with suspected/confirmed COVID-19.
Who may be able to join
- Adults ≥18 years admitted to ICU with SARS-CoV-2 and survived
- Relatives or friends and professionals involved in the care of these patients.
Who cannot join
- Patients <18 years;
- Patients with a negative test for SARS-CoV-2 or patients not tested due to absence of symptoms;
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical
Chelsea critical care physical assessment tool
Measured: through study completion , an average of 1 year
Physical
Incremental Shuttle Walk Test (ISWT)
Measured: through study completion , an average of 1 year
Physical
1- minute Sit to Stand, Grip strength
Measured: through study completion , an average of 1 year
Health Related Quality of life
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.
Measured: at 3 months
Health Related Quality of life
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.
Measured: at 1 year
Psychological
Depression Test Questionnaire (PHQ-9). Scores range from 1 to 27 and higher scores indicate worse outcome.
Measured: through study completion , an average of 1 year
Psychological
Anxiety Test Questionnaire (GAD-7). Scores range from 0 to 21 and higher scores indicates worse outcome.
Measured: through study completion , an average of 1 year
Psychological
Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30 and higher scores indicate a better outcome.
Measured: through study completion , an average of 1 year
Psychological
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.
Measured: at 1 year
Secondary outcomes (3)
risk stratification
escalation to critical care (Yes/No)
Measured: through study completion and average of 1 year
risk stratification
mechanical ventilation (Yes/No)
Measured: through study completion and average of 1 year
risk stratification
critical care stay hospital stay (number of days)
Measured: through study completion and average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start5 May 2020
- Primary completion8 May 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sussex Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Luke Hodgson, Principal investigator, Western Sussex Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524520
- Sponsor's protocol ID
- 20/YH/0157
- Status last verified
- Jul 2022
- First submitted
- 19 Aug 2020
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04524520
- Acronym / sponsor ID
- 20/YH/0157
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Western Sussex Hospitals NHS TrustUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to hospital with suspected/confirmed COVID-19.
Key inclusion criteria (2 listed)
- Adults ≥18 years admitted to ICU with SARS-CoV-2 and survived
- Relatives or friends and professionals involved in the care of these patients.
Key exclusion criteria (2 listed)
- Patients <18 years;
- Patients with a negative test for SARS-CoV-2 or patients not tested due to absence of symptoms;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical
Time frame: through study completion , an average of 1 year
Chelsea critical care physical assessment tool
Physical
Time frame: through study completion , an average of 1 year
Incremental Shuttle Walk Test (ISWT)
Physical
Time frame: through study completion , an average of 1 year
1- minute Sit to Stand, Grip strength
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.
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.
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.
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.
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.
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.
3 secondary outcomes
risk stratification
Time frame: through study completion and average of 1 year
risk stratification
Time frame: through study completion and average of 1 year
risk stratification
Time frame: through study completion and average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Luke Hodgson principal investigator
Western Sussex Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised Patients, run by Western Sussex Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical (time frame: through study completion , an average of 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.