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

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ClinicalTrials.gov Identifier: NCT04459351
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

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.

Condition or disease
Coronavirus Corona Virus Infection COVID-19 2019nCoV 2019 Novel Coronavirus Infection

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Identification of baseline characteristics which correlate with disease severity [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes.

  2. Identification of blood biomarkers which correlate with disease severity [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    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.

  3. Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    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


Secondary Outcome Measures :
  1. Incidence [ Time Frame: Based on clinical need - Up to 1 year follow up. ]

    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

  2. Change in respiratory symptom scores [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21

  3. Change in respiratory symptom scores [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4.

  4. Change in frailty and quality of life scores [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100.

  5. Change in frailty and quality of life scores [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    Assessed through the Clinical Frailty Scale: Scores range from 1-9.

  6. Relationship between serum markers and clinical outcomes [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    D dimer/ fibrinogen and new pulmonary embolism

  7. Relationship between serum markers and clinical outcomes [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    Troponin/ BNP and cardiac disease

  8. Relationship between serum markers and clinical outcomes [ Time Frame: Based on clinical need - Up to 1 year follow up. ]
    Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities


Other Outcome Measures:
  1. Thematic analysis of semi-structured interviews exploring the following areas: [ Time Frame: Up to 1 year follow up. ]
    • 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


Biospecimen Retention:   Samples With DNA
  • Blood samples: 20 additional mls taken at each routine follow-up visit.
  • Endobronchial samples (washings/brushings/biopsy) if a bronchoscopy is deemed necessary for the clinical care of the patient


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459351


Contacts
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Contact: Research Delivery Operations Manager 020 3315 6825 research.development@chewest.nhs.uk
Contact: Pallav Shah, MBBS, MD 02087468063 pallav.shah@chelwest.nhs.uk

Locations
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United Kingdom
Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact: Research Delivery Operations Manager    020 3315 6825    research.development@chelwest.nhs.uk   
Principal Investigator: Pallav Shah         
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Investigators
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Principal Investigator: Pallav Shah, MBBS, MD Chelsea and Westminster Hospital NHS Foundation Trust
Publications:
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]

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Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04459351    
Other Study ID Numbers: C&W20/035
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chelsea and Westminster NHS Foundation Trust:
COVID-19
Blood phenotyping
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases