PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs
- Conditions
- COVID-192019nCoV2019 Novel Coronavirus InfectionCoronavirusCorona Virus Infection
- Registration Number
- NCT04459351
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of blood biomarkers which correlate with disease severity 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.
Identification of baseline characteristics which correlate with disease severity 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.
Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations 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
Name Time Method Relationship between serum markers and clinical outcomes Based on clinical need - Up to 1 year follow up. Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities
Change in frailty and quality of life scores Based on clinical need - Up to 1 year follow up. Assessed through the Clinical Frailty Scale: Scores range from 1-9.
Incidence 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 scaleChange in respiratory symptom scores Based on clinical need - Up to 1 year follow up. Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4.
Trial Locations
- Locations (1)
Chelsea and Westminster Hospital
🇬🇧London, United Kingdom