PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs
PHENOTYPE
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedStudy Start
First participant enrolled
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedAugust 9, 2021
August 1, 2021
2.9 years
June 18, 2020
August 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
Incidence
Based on clinical need - Up to 1 year follow up.
Change in respiratory symptom scores
Based on clinical need - Up to 1 year follow up.
Change in respiratory symptom scores
Based on clinical need - Up to 1 year follow up.
Change in frailty and quality of life scores
Based on clinical need - Up to 1 year follow up.
Change in frailty and quality of life scores
Based on clinical need - Up to 1 year follow up.
- +3 more secondary outcomes
Other Outcomes (1)
Thematic analysis of semi-structured interviews exploring the following areas:
Up to 1 year follow up.
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
Related Publications (3)
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]
BACKGROUNDChan 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: 15018132BACKGROUNDVijayakumar 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.
PMID: 34609195DERIVED
Biospecimen
* 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pallav Shah, MBBS, MD
Chelsea and Westminster NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
July 7, 2020
Study Start
June 19, 2020
Primary Completion
May 1, 2023
Study Completion
June 1, 2023
Last Updated
August 9, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share