2019nCoV, 2019 Novel Coronavirus Infection, Coronavirus, Corona Virus Infection, COVID-19
Conditions
Keywords
COVID-19, Blood phenotyping
Brief summary
PHENOTYPE is an investigator-led, observational cohort study which aims to explore the long-term outcomes of patients with COVID-19 infection and to identify potential risk factors and biomarkers that can prognosticate disease severity and trajectory.
Detailed description
In 2019, a novel coronavirus, SARS-CoV-2 was first identified in Wuhan, China. SARS-CoV-2 infection, denominated COVID-19, causes a predominantly respiratory illness, which varies from mild respiratory symptoms to multi-organ failure and death. In March 2020, COVID-19 was designated pandemic status and as of May 2020 there have been more than 3.7 million cases reported worldwide and 257,000 deaths attributed. In the UK, COVID-19 has caused more than 30,000 deaths to date. Although respiratory symptoms are the commonest presentation, numerous systemic complications of COVID-19 have been identified, including those affecting the cardiovascular, neurological, gastroenterological, and renal systems. The long-term impact of these complications on survivors and the risk factors for long term sequelae is not presently known. It is likely that increased frailty and psychological sequelae will be significant, which could lead to a persistent reduction in quality of life, as observed in the previous SARS pandemic. This cohort study aims to evaluate the respiratory, cardiac, renal and psychological outcomes of patients diagnosed with COVID-19 infection and determine the pathophysiological mechanisms that contribute to disease severity and disease burden.
Interventions
None listed
Sponsors
Chelsea and Westminster NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Confirmed COVID-19 infection (as per national guidelines) * Attending follow-up outpatient visit post hospital attendance with COVID-19 infection
Exclusion criteria
There are no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations | Based on clinical need - Up to 1 year follow up. | Genomic, proteomic and transcriptomic analysis of blood samples to look for genetic susceptibility to severe disease presentations and to identify new biomarkers that predict disease severity or disease trajectory |
| Identification of baseline characteristics which correlate with disease severity | Based on clinical need - Up to 1 year follow up. | The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes. |
| Identification of blood biomarkers which correlate with disease severity | Based on clinical need - Up to 1 year follow up. | Relationship between changes in markers of inflammation (CRP, D dimer, ferritin, fibrinogen, pro-calcitonin) and pulmonary, renal and cardiac complications post hospitalisation for Covid-19 infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in frailty and quality of life scores | Based on clinical need - Up to 1 year follow up. | Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100. |
| Relationship between serum markers and clinical outcomes | Based on clinical need - Up to 1 year follow up. | D dimer/ fibrinogen and new pulmonary embolism |
| Incidence | Based on clinical need - Up to 1 year follow up. | Incidence of: * Interstitial lung disease * Pulmonary embolism * Pulmonary hypertension as determined by pulmonary artery systolic pressure on echocardiogram or mean pulmonary artery pressure on right heart catheterisation if performed * Renal dysfunction (as defined by new persistent impairment of egfr or new sustained protenuria measured using urinary protein-creatinine ratio) * Cardiac dysfunction (new LV or RV systolic dysfunction on echocardiogram) * Psychological distress as measured using Hospital anxiety and depression scale |
| Change in respiratory symptom scores | Based on clinical need - Up to 1 year follow up. | Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Thematic analysis of semi-structured interviews exploring the following areas: | Up to 1 year follow up. | * Changes in health behaviours such as alcohol consumption and tobacco use * Mental health and psychological wellbeing * Factors affecting compliance with Public Health England guidelines * The impact of cultural and religious beliefs on behaviours during the pandemic |
Countries
United Kingdom
Contacts
Primary ContactResearch Delivery Operations Manager
Backup ContactPallav Shah, MBBS, MD
Outcome results
None listed