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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 194

Contacts and Locations

Study Locations

• United Kingdom
  • Worthing, United Kingdom
    • Dr Luke Hodgson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to hospital with suspected/confirmed COVID-19.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical	Chelsea critical care physical assessment tool	through study completion , an average of 1 year
Physical	Incremental Shuttle Walk Test (ISWT)	through study completion , an average of 1 year
Physical	1- minute Sit to Stand, Grip strength	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.	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.	at 1 year
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk stratification	escalation to critical care (Yes/No)	through study completion and average of 1 year
risk stratification	mechanical ventilation (Yes/No)	through study completion and average of 1 year
risk stratification	critical care stay hospital stay (number of days)	through study completion and average of 1 year

Collaborators and Investigators

• Sponsor: Western Sussex Hospitals NHS Trust
• Investigators: Principal Investigator: Dr Luke Hodgson, Western Sussex Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Actual): May 8, 2022
• Study Completion (Actual): June 8, 2022

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: 20/YH/0157

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No