Clinical trial NCT04459351: PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs
Official title: PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus
Corona Virus Infection
COVID-19
2019nCoV
2019 Novel Coronavirus Infection
Keywords: COVID-19
Blood phenotyping
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of baseline characteristics which correlate with disease severity
timeFrame: Based on clinical need - Up to 1 year follow up.
measure: Identification of blood biomarkers which correlate with disease severity
timeFrame: Based on clinical need - Up to 1 year follow up.
measure: Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations
timeFrame: Based on clinical need - Up to 1 year follow up.
Secondary outcomes:
measure: Incidence
timeFrame: Based on clinical need - Up to 1 year follow up.
measure: Change in respiratory symptom scores
timeFrame: Based on clinical need - Up to 1 year follow up.
measure: Change in respiratory symptom scores
timeFrame: Based on clinical need - Up to 1 year follow up.
measure: Change in frailty and quality of life scores
timeFrame: Based on clinical need - Up to 1 year follow up.
measure: Change in frailty and quality of life scores
timeFrame: Based on clinical need - Up to 1 year follow up.
measure: Relationship between serum markers and clinical outcomes
timeFrame: Based on clinical need - Up to 1 year follow up.
measure: Relationship between serum markers and clinical outcomes
timeFrame: Based on clinical need - Up to 1 year follow up.
measure: Relationship between serum markers and clinical outcomes
timeFrame: Based on clinical need - Up to 1 year follow up.
Other outcomes:
measure: Thematic analysis of semi-structured interviews exploring the following areas:
timeFrame: Up to 1 year follow up.
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Pallav Shah, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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]
citation: 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.
citation: 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.