PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs

Study Overview
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Brief Summary
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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
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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.

Official Title
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PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs

Conditions
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Coronavirus, Corona Virus Infection, COVID-19, 2019nCoV, 2019 Novel Coronavirus Infection

Participation Criteria
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Eligibility Criteria
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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 exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of baseline characteristics which correlate with disease severity | The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes. | Based on clinical need - Up to 1 year follow up. | 
| Identification of blood biomarkers which correlate with disease severity | 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. | Based on clinical need - Up to 1 year follow up. | 
| Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations | 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 | Based on clinical need - Up to 1 year follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence | 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 | Based on clinical need - Up to 1 year follow up. | 
| Change in respiratory symptom scores | Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21 | Based on clinical need - Up to 1 year follow up. | 
| Change in respiratory symptom scores | Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4. | Based on clinical need - Up to 1 year follow up. | 
| Change in frailty and quality of life scores | Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100. | Based on clinical need - Up to 1 year follow up. | 
| Change in frailty and quality of life scores | Assessed through the Clinical Frailty Scale: Scores range from 1-9. | Based on clinical need - Up to 1 year follow up. | 
| Relationship between serum markers and clinical outcomes | D dimer/ fibrinogen and new pulmonary embolism | Based on clinical need - Up to 1 year follow up. | 
| Relationship between serum markers and clinical outcomes | Troponin/ BNP and cardiac disease | Based on clinical need - Up to 1 year follow up. | 
| Relationship between serum markers and clinical outcomes | Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities | Based on clinical need - Up to 1 year follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Blood phenotyping