<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04459351</url>
  </required_header>
  <id_info>
    <org_study_id>C&amp;W20/035</org_study_id>
    <nct_id>NCT04459351</nct_id>
  </id_info>
  <brief_title>PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs</brief_title>
  <acronym>PHENOTYPE</acronym>
  <official_title>PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chelsea and Westminster NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chelsea and Westminster NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      PHENOTYPE is an investigator-led, observational cohort study which aims to explore the&#xD;
      long-term outcomes of patients with COVID-19 infection and to identify potential risk factors&#xD;
      and biomarkers that can prognosticate disease severity and trajectory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2019, a novel coronavirus, SARS-CoV-2 was first identified in Wuhan, China. SARS-CoV-2&#xD;
      infection, denominated COVID-19, causes a predominantly respiratory illness, which varies&#xD;
      from mild respiratory symptoms to multi-organ failure and death. In March 2020, COVID-19 was&#xD;
      designated pandemic status and as of May 2020 there have been more than 3.7 million cases&#xD;
      reported worldwide and 257,000 deaths attributed. In the UK, COVID-19 has caused more than&#xD;
      30,000 deaths to date.&#xD;
&#xD;
      Although respiratory symptoms are the commonest presentation, numerous systemic complications&#xD;
      of COVID-19 have been identified, including those affecting the cardiovascular, neurological,&#xD;
      gastroenterological, and renal systems. The long-term impact of these complications on&#xD;
      survivors and the risk factors for long term sequelae is not presently known. It is likely&#xD;
      that increased frailty and psychological sequelae will be significant, which could lead to a&#xD;
      persistent reduction in quality of life, as observed in the previous SARS pandemic.&#xD;
&#xD;
      This cohort study aims to evaluate the respiratory, cardiac, renal and psychological outcomes&#xD;
      of patients diagnosed with COVID-19 infection and determine the pathophysiological mechanisms&#xD;
      that contribute to disease severity and disease burden.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of baseline characteristics which correlate with disease severity</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of blood biomarkers which correlate with disease severity</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>Incidence of:&#xD;
Interstitial lung disease&#xD;
Pulmonary embolism&#xD;
Pulmonary hypertension as determined by pulmonary artery systolic pressure on echocardiogram or mean pulmonary artery pressure on right heart catheterisation if performed&#xD;
Renal dysfunction (as defined by new persistent impairment of egfr or new sustained protenuria measured using urinary protein-creatinine ratio)&#xD;
Cardiac dysfunction (new LV or RV systolic dysfunction on echocardiogram)&#xD;
Psychological distress as measured using Hospital anxiety and depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory symptom scores</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory symptom scores</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in frailty and quality of life scores</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in frailty and quality of life scores</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>Assessed through the Clinical Frailty Scale: Scores range from 1-9.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between serum markers and clinical outcomes</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>D dimer/ fibrinogen and new pulmonary embolism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between serum markers and clinical outcomes</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>Troponin/ BNP and cardiac disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between serum markers and clinical outcomes</measure>
    <time_frame>Based on clinical need - Up to 1 year follow up.</time_frame>
    <description>Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Thematic analysis of semi-structured interviews exploring the following areas:</measure>
    <time_frame>Up to 1 year follow up.</time_frame>
    <description>Changes in health behaviours such as alcohol consumption and tobacco use&#xD;
Mental health and psychological wellbeing&#xD;
Factors affecting compliance with Public Health England guidelines&#xD;
The impact of cultural and religious beliefs on behaviours during the pandemic</description>
  </other_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Coronavirus</condition>
  <condition>Corona Virus Infection</condition>
  <condition>COVID-19</condition>
  <condition>2019nCoV</condition>
  <condition>2019 Novel Coronavirus Infection</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  Blood samples: 20 additional mls taken at each routine follow-up visit.&#xD;
&#xD;
        -  Endobronchial samples (washings/brushings/biopsy) if a bronchoscopy is deemed necessary&#xD;
           for the clinical care of the patient&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients (aged 18 or older) who have attended hospital with proven COVID-19&#xD;
        infection and are being followed up in clinic are potential candidates for study enrolment.&#xD;
        A member of the clinical or research team will screen the patient against the eligibility&#xD;
        criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Confirmed COVID-19 infection (as per national guidelines)&#xD;
&#xD;
          -  Attending follow-up outpatient visit post hospital attendance with COVID-19 infection&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        There are no specific exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pallav Shah, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chelsea and Westminster NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Research Delivery Operations Manager</last_name>
    <phone>020 3315 6825</phone>
    <email>research.development@chewest.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pallav Shah, MBBS, MD</last_name>
    <phone>02087468063</phone>
    <email>pallav.shah@chelwest.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Delivery Operations Manager</last_name>
      <phone>020 3315 6825</phone>
      <email>research.development@chelwest.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Pallav Shah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Wong, S., Vaughan, A., Quilty-Harper, C. &amp; 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>
  </reference>
  <reference>
    <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>
    <PMID>15018132</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Blood phenotyping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04459351
org study id: C&W20/035
nct id: NCT04459351
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Other
measure: Identification of baseline characteristics which correlate with disease severity
time frame: Based on clinical need - Up to 1 year follow up.
description: The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes.
measure: Identification of blood biomarkers which correlate with disease severity
time frame: Based on clinical need - Up to 1 year follow up.
description: 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.
measure: 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.
description: 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
measure: Incidence
time frame: Based on clinical need - Up to 1 year follow up.
description: 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
measure: Change in respiratory symptom scores
time frame: Based on clinical need - Up to 1 year follow up.
description: Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21
measure: Change in respiratory symptom scores
time frame: Based on clinical need - Up to 1 year follow up.
description: Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4.
measure: Change in frailty and quality of life scores
time frame: Based on clinical need - Up to 1 year follow up.
description: Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100.
measure: Change in frailty and quality of life scores
time frame: Based on clinical need - Up to 1 year follow up.
description: Assessed through the Clinical Frailty Scale: Scores range from 1-9.
measure: Relationship between serum markers and clinical outcomes
time frame: Based on clinical need - Up to 1 year follow up.
description: D dimer/ fibrinogen and new pulmonary embolism
measure: Relationship between serum markers and clinical outcomes
time frame: Based on clinical need - Up to 1 year follow up.
description: Troponin/ BNP and cardiac disease
measure: Relationship between serum markers and clinical outcomes
time frame: Based on clinical need - Up to 1 year follow up.
description: Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities
measure: Thematic analysis of semi-structured interviews exploring the following areas:
time frame: Up to 1 year follow up.
description: 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
-  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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pallav Shah, MBBS, MD
role: Principal Investigator
affiliation: Chelsea and Westminster NHS Foundation Trust
last name: Research Delivery Operations Manager
phone: 020 3315 6825
email: research.development@chewest.nhs.uk
last name: Pallav Shah, MBBS, MD
phone: 02087468063
email: pallav.shah@chelwest.nhs.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
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.
PMID: 15018132
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No