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CoronavirusPHENOTYPENCT04459351

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

An observational study of Coronavirus and Corona Virus Infection, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus, Corona Virus Infection, COVID-19
How many people
500 participants
Where
1 siteUnited Kingdom
Study dates
19 Jun 2020to Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • There are no specific exclusion criteria

Trial locations and contacts

1 site in 1 country.

Research Delivery Operations Manager contact

020 3315 6825

research.development@chewest.nhs.uk

Pallav Shah, MBBS, MD contact

02087468063

pallav.shah@chelwest.nhs.uk

United Kingdom1 site, 1 recruiting

  • Chelsea and Westminster Hospital

    London, SW10 9NH

    Research Delivery Operations Manager, 020 3315 6825, research.development@chelwest.nhs.uk

    Pallav Shah

    Recruiting

Other trials in United Kingdom

About this study

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.

Read the 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.

Keywords
COVID-19, Blood phenotyping
Medical subject headings
Coronavirus Infections, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Based on clinical need - Up to 1 year follow up.

  2. 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.

    Measured: Based on clinical need - Up to 1 year follow up.

  3. 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

    Measured: Based on clinical need - Up to 1 year follow up.

Secondary outcomes (8)

  1. 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

    Measured: Based on clinical need - Up to 1 year follow up.

  2. Change in respiratory symptom scores

    Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21

    Measured: Based on clinical need - Up to 1 year follow up.

  3. Change in respiratory symptom scores

    Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4.

    Measured: Based on clinical need - Up to 1 year follow up.

  4. Change in frailty and quality of life scores

    Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100.

    Measured: Based on clinical need - Up to 1 year follow up.

  5. Change in frailty and quality of life scores

    Assessed through the Clinical Frailty Scale: Scores range from 1-9.

    Measured: Based on clinical need - Up to 1 year follow up.

  6. Relationship between serum markers and clinical outcomes

    D dimer/ fibrinogen and new pulmonary embolism

    Measured: Based on clinical need - Up to 1 year follow up.

  7. Relationship between serum markers and clinical outcomes

    Troponin/ BNP and cardiac disease

    Measured: Based on clinical need - Up to 1 year follow up.

  8. Relationship between serum markers and clinical outcomes

    Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities

    Measured: Based on clinical need - Up to 1 year follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start19 Jun 2020
  3. Primary completionMay 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459351
Sponsor's protocol ID
C&W20/035
Acronym
PHENOTYPE
Status last verified
Aug 2021
First submitted
18 Jun 2020
Last updated
9 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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]

  • 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.

    PubMed 15018132

  • 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.

    PubMed 34609195

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus and Corona Virus Infection, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Research Delivery Operations Manager (020 3315 6825, research.development@chewest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of baseline characteristics which correlate with disease severity (time frame: Based on clinical need - Up to 1 year follow up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04459351, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.

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