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

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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524520
• Other study ID #: 20/YH/0157
• Status: Completed
• Start date: May 5, 2020
• Est. completion date: June 8, 2022

Study information

• Verified date: July 2022
• Source: Western Sussex Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 8, 2022
• Est. primary completion date: May 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults =18 years admitted to ICU with SARS-CoV-2 and survived

2. Relatives or friends and professionals involved in the care of these patients.

Exclusion Criteria:

1. Patients <18 years;

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United Kingdom	Dr Luke Hodgson	Worthing

Sponsors (1)

Lead Sponsor	Collaborator
Western Sussex Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical	Chelsea critical care physical assessment tool	through study completion , an average of 1 year
Primary	Physical	Incremental Shuttle Walk Test (ISWT)	through study completion , an average of 1 year
Primary	Physical	1- minute Sit to Stand, Grip strength	through study completion , an average of 1 year
Primary	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.	at 3 months
Primary	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.	at 1 year
Primary	Psychological	Depression Test Questionnaire (PHQ-9). Scores range from 1 to 27 and higher scores indicate worse outcome.	through study completion , an average of 1 year
Primary	Psychological	Anxiety Test Questionnaire (GAD-7). Scores range from 0 to 21 and higher scores indicates worse outcome.	through study completion , an average of 1 year
Primary	Psychological	Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30 and higher scores indicate a better outcome.	through study completion , an average of 1 year
Primary	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.	at 1 year
Secondary	risk stratification	escalation to critical care (Yes/No)	through study completion and average of 1 year
Secondary	risk stratification	mechanical ventilation (Yes/No)	through study completion and average of 1 year
Secondary	risk stratification	critical care stay hospital stay (number of days)	through study completion and average of 1 year