Clinical trial NCT04524520: COVID19-OR (SARS-CoV-2): Observation,Risk & Recovery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised Patients
Lead sponsor: Western Sussex Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults admitted to hospital with suspected/confirmed COVID-19.

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Physical
timeFrame: through study completion , an average of 1 year
measure: Physical
timeFrame: through study completion , an average of 1 year
measure: Physical
timeFrame: through study completion , an average of 1 year
measure: Health Related Quality of life
timeFrame: at 3 months
measure: Health Related Quality of life
timeFrame: at 1 year
measure: Psychological
timeFrame: through study completion , an average of 1 year
measure: Psychological
timeFrame: through study completion , an average of 1 year
measure: Psychological
timeFrame: through study completion , an average of 1 year
measure: Psychological
timeFrame: at 1 year
Secondary outcomes:
measure: risk stratification
timeFrame: through study completion and average of 1 year
measure: risk stratification
timeFrame: through study completion and average of 1 year
measure: risk stratification
timeFrame: through study completion and average of 1 year
Other outcomes:
Locations:
city: Worthing
country: United Kingdom
facility: Dr Luke Hodgson
Study officials:
affiliation: Western Sussex Hospitals NHS Trust
name: Dr Luke Hodgson
role: PRINCIPAL_INVESTIGATOR
References: