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

COVID-19 Clinical Trial

— PHENOTYPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04459351
• Other study ID #: C&W20/035
• Status: Recruiting
• Start date: June 19, 2020
• Est. completion date: June 2023

Study information

• Verified date: August 2021
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: Research Delivery Operations Manager
• Phone: 020 3315 6825
• Email: research.development[@]chewest.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 2019 Novel Coronavirus Infection
• 2019nCoV
• Communicable Diseases
• Corona Virus Infection
• Coronavirus
• Coronavirus Infections
• COVID-19
• Infection

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Chan KS, Zheng JP, Mok YW, Li YM, Liu YN, Chu CM, Ip MS. SARS: prognosis, outcome and sequelae. Respirology. 2003 Nov;8 Suppl:S36-40. Review. — View 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]

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Relationship between serum markers and clinical outcomes	D dimer/ fibrinogen and new pulmonary embolism	Based on clinical need - Up to 1 year follow up.
Secondary	Relationship between serum markers and clinical outcomes	Troponin/ BNP and cardiac disease	Based on clinical need - Up to 1 year follow up.
Secondary	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.