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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Corona Virus Infection; Coronavirus; 2019 Novel Coronavirus Infection; 2019nCoV

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Research Delivery Operations Manager; Phone Number: 020 3315 6825; Email: research.development@chewest.nhs.uk
• Study Contact Backup: Name: Pallav Shah, MBBS, MD; Phone Number: 02087468063; Email: pallav.shah@chelwest.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Recruiting
    • Chelsea and Westminster Hospital
    • Principal Investigator: Pallav Shah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thematic analysis of semi-structured interviews exploring the following areas:	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	Up to 1 year follow up.

Collaborators and Investigators

• Sponsor: Chelsea and Westminster NHS Foundation Trust
• Investigators: Principal Investigator: Pallav Shah, MBBS, MD, Chelsea and Westminster Hospital NHS Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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]
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Blood phenotyping
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: C&W20/035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No