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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.
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.
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| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence | Incidence of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Thematic analysis of semi-structured interviews exploring the following areas: |
| Up to 1 year follow up. |
Inclusion Criteria
Exclusion Criteria
There are no specific exclusion criteria
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All adult patients (aged 18 or older) who have attended hospital with proven COVID-19 infection and are being followed up in clinic are potential candidates for study enrolment. A member of the clinical or research team will screen the patient against the eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Delivery Operations Manager | Contact | 020 3315 6825 | research.development@chewest.nhs.uk | |
| Pallav Shah, MBBS, MD | Contact | 02087468063 | pallav.shah@chelwest.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Pallav Shah, MBBS, MD | Chelsea and Westminster NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster Hospital | Recruiting | London | SW10 9NH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wong, S., Vaughan, A., Quilty-Harper, C. & Liverpool,L. Black people in England and Wales twice as likely to die with covid-19. New Scientist. 2020. Available from: https://www.newscientist.com/article/2237475-covid-19-news-uk-economy-shrank-at-fastest-pace-since-2008/[Accessed: 10th May 2020] | ||
| 15018132 | Background | Chan KS, Zheng JP, Mok YW, Li YM, Liu YN, Chu CM, Ip MS. SARS: prognosis, outcome and sequelae. Respirology. 2003 Nov;8 Suppl(Suppl 1):S36-40. doi: 10.1046/j.1440-1843.2003.00522.x. | |
| 34609195 |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| 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. |
| Derived |
| Vijayakumar B, Tonkin J, Devaraj A, Philip KEJ, Orton CM, Desai SR, Shah PL. CT Lung Abnormalities after COVID-19 at 3 Months and 1 Year after Hospital Discharge. Radiology. 2022 May;303(2):444-454. doi: 10.1148/radiol.2021211746. Epub 2021 Oct 5. |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |