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COVID-19 Hyperinflammation Syndrome (COV-HI): Protocol for a Rapidly Executed Cohort Study (COV-HI)

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ClinicalTrials.gov Identifier: NCT04385069
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
Newcastle-upon-Tyne Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
Nottingham University Hospitals NHS Trust
University College London Hospitals
Information provided by (Responsible Party):
University College, London

Brief Summary:
Based on emerging experience and trials from countries affected early by the COVID-19 (COV19) pandemic, there is evidence that a subgroup of severely affected people develop a hyperinflammatory (HI) syndrome (COV-HI). Trials are in progress of cytokine inhibition and other immune modulation to treat COV-HI. This proposal aims to use a rapidly executed cohort study to characterise the clinical phenotypes of COV-HI in patients in the UK through an established and nimble network of clinicians and scientists with broad experience of identifying and treating HI. The aim is to confirm the COV-HI clinical phenotype and using routine data to try to infer the inflexion point where COV-HI emerges. This would enable refinement of the proposed treatment algorithm and translates to routine clinical practice to improve the outlook for COV-HI.

Condition or disease
COV-HI COVID-19 COVID-19 (COV) Hyperinflammatory (HI) Syndrome

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: COVID-19 Hyperinflammation Syndrome (COV-HI): Protocol for a Rapidly Executed Cohort Study
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : July 5, 2020
Estimated Study Completion Date : July 5, 2020



Primary Outcome Measures :
  1. To collect retrospective demographic information on 500 people admitted to selected hospital sites across the UK with a COVID-19 diagnosis confirmed through positive laboratory PCR swab. [ Time Frame: within 3 months ]
    Confirm positive diagnosis within electronic hospital records and collate selected demographic data from eligible patients identified.

  2. To record the results of each patient's measured medical observations, clinical investigations and outcomes during the course of their admission. [ Time Frame: within 3 months ]
    Research staff will review the electronic patient record for all eligible participants and record the results of each patients routine blood tests, chest x-rays, echos and any other associated clinical investigations conducted during the course of their admission onto a database for analysis.

  3. To conduct retrospective analysis of data collected to map each patient's clinical journey during their admission [ Time Frame: within 3 months of data collection ]
    Research staff will record data collected from eligible patients' electronic medical records from routine blood tests, chest x-rays, echos and any other associated clinical investigations conducted during the course of their admission onto a database and conduct comprehensive analysis.



Information from the National Library of Medicine

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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
Individuals who meet the inclusion criteria at the selected NHS Trusts.
Criteria

Inclusion Criteria:

- Adults (18 years and over) admitted to hospital who are COVID-19 positive (PCR positive on a swab, through routine clinical laboratory testing)

Exclusion Criteria:

- No 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): NCT04385069


Contacts
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Contact: Jessica Manson, Dr 02034479035 jessica.manson@nhs.net

Locations
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United Kingdom
The Leeds Teaching Hospitals NHS Trust, St James University Hospital Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Sinisa Savic       s.savic@leeds.ac.uk   
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2BU
Contact: Jessica Manson, Dr    02034479035    jessica.manson@nhs.net   
Contact: Amanda Ledlie    02031082161    a.ledlie@nhs.net   
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Matthew Collin, Prof.       matthewcollin@nhs.net   
Nottingham University Hospitals NHS Trust Not yet recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Joe West, Prof.       joe.west@nottingham.ac.uk   
Sheffield Teaching Hospitals NHS Trust, Northern General Hospital Not yet recruiting
Sheffield, United Kingdom, S5 7AU
Contact: Rachel Tattershall       rachel.tattersahll@nhs.net   
Sponsors and Collaborators
University College, London
Newcastle-upon-Tyne Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
Nottingham University Hospitals NHS Trust
University College London Hospitals
Investigators
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Principal Investigator: Jessica Manson, Dr University College London Hospital
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04385069    
Other Study ID Numbers: 132388
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes