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

Completed

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

• Registration Number: NCT04524520
• Lead Sponsor: Western Sussex Hospitals NHS Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-05
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-24
• Primary Completion: 2022-05-08
• Study Completion: 2022-06-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Related Quality of life	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	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.
Physical	through study completion , an average of 1 year	1- minute Sit to Stand, Grip strength

Secondary Outcome Measures

Name	Time	Method
risk stratification	through study completion and average of 1 year	critical care stay hospital stay (number of days)

Trial Locations

Locations (1)

Dr Luke Hodgson; 🇬🇧 Worthing, United Kingdom