Adult survivors of a hospital admission with COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant admitted to an acute admissions unit or ward at a UK hospital and discharged with suspected COVID-19 2. Age 18 years and over 3. Participant is willing and able to give informed consent for participation in the study 4. Aged 18 years or above
Exclusion criteria
Exclusion criteria: 1. Confirmed diagnosis of a pathogen unrelated to the objectives of this study and no indication or likelihood of co-infection with a relevant pathogen 2. Attendance at an A&E or emergency department only 3. Refusal by participant, parent or appropriate representative 4. Other life-limiting illness with life expectancy <6 months such as disseminated malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/11/2021: 1. Incidence of long-term sequelae of COVID-19 measured using multiple methods including: 1.1. Symptoms and quality of life measured using one or more of the following questionnaires: EQ-5D, Dyspnoea-12, Fatigue (FACIT), Brief Pain Inventory (BPI), MRC dyspnoea score, Montreal Cognitive Assessment (MoCA), Clinical Frailty Scale 1.2. Mental health: symptoms of anxiety assessed using Generalised Anxiety Disorder Assessment (GAD-7), depression assessed using Patient Health Questionnaire (PHQ-9), post-traumatic stress disorder (PTSD) checklist (PCL-5) 1.3. Physical function measured using one or more the following tests: Short Physical Performance Battery (SPPB), Incremental Shuttle Walk Test (ISWT), muscle strength tests (handgrip strength), physical activity monitoring 1.4. Biological samples taken e.g blood, urine, sputum, saliva, breath 1.5. Any imaging as part of clinical care Measured at 6 weeks - 7.5 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years) Please note that not all participants will be asked to complete or perform all of the above questionnaires and tests. Data from routine clinical investigations and tests will be recorded. 2. Healthcare utilisation measured using questionnaires and linkage to health and social care records at 6 weeks, 3 months, 6 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years) 3. Mortality measured using ONS data at 6 weeks, 3 months, 6 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years) _____ Previous primary outcome measure: 1. Incidence of long-term sequelae of COVID-19 measured using multiple methods including: 1.1. Symptoms and quality of life measured using one or more of the following questionnaires: EQ-5D, Sarcopenia screen (SARC-F), General Practice Physical Activity Questionnaire (GPPAQ), Dyspnoea-12, Fatigue (FAC | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/11/2021: Characterisation of specific long-term morbidities and impacts of COVID-19 hospitalisation measured using multiple methods including: 1. Symptoms and quality of life measured using one or more of the following questionnaires: EQ-5D, Sarcopenia screen (SARC-F), General Practice Physical Activity Questionnaire (GPPAQ), Dyspnoea-12, Fatigue (FACIT), Brief Pain Inventory (BPI), Nottingham extended activity of daily living (NEADL), MRC dyspnoea score, Montreal Cognitive Assessment (MoCA), Clinical Frailty Scale, Fried Frailty assessment 2. Mental health: symptoms of anxiety assessed using Generalised Anxiety Disorder Assessment (GAD-7), depression assessed using Patient Health Questionnaire (PHQ-9), post-traumatic stress disorder (PTSD) checklist (PCL-5) 3. Physical function measured using one or more the following tests: Short Physical Performance Battery (SPPB), Incremental Shuttle Walk Test (ISWT), muscle strength tests (handgrip and quadriceps strength), physical activity monitoring, cardiometabolic risk assessment and body composition measurements 4. Biological samples taken e.g blood, urine, sputum, saliva, breath 5. Any imaging as part of clinical care 6. Healthcare utilisation assessed from linkage to health and social care records Measured at 6 weeks - 7.5 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years) Please note that not all participants will be asked to complete or perform all of the above questionnaires and tests. Data from routine clinical investigations and tests will be recorded. _____ Previous secondary outcome measures: Characterisation of specific long-term morbidities and impacts of COVID-19 hospitalisation measured using multiple methods including: 1. Symptoms and quality of life measured using one or more of the following questionnaires: EQ-5D, Sarcopenia screen (SARC-F), General Practice Physical Activity Questionnaire (GPPAQ), Dysp | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales