Official Title
COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2
Brief Summary

Modelling repurposed from pandemic influenza is currently informing all strategies for SARS-CoV-2 and the disease COVID-19. A customized disease specific understanding will be important to understand subsequent disease waves, vaccine development and therapeutics. For this reason, ISARIC (the International Severe Acute Respiratory and Emerging Infection Consortium) was set up in advance. This focuses on hospitalised and convalescent serum samples to understand severe illness and associated immune response. However, many subjects are seroconverting with mild or even subclinical disease. Information is needed about subclinical infection, the significance of baseline immune status and the earliest immune changes that may occur in mild disease to compare with those of SARS-CoV-2. There is also a need to understand the vulnerability and response to COVID-19 of the NHS workforce of healthcare workers (HCWs). HCW present a cohort with likely higher exposure and seroconversion rates than the general population, but who can be followed up with potential for serial testing enabling an insight into early disease and markers of risk for disease severity. We have set up "COVID-19: Healthcare worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2". This urgent fieldwork aims to secure significant (n=400) sampling of healthcare workers (demographics, swabs, blood sampling) at baseline, and weekly whilst they are well and attending work, with acute sampling (if hospitalised, via ISARIC, if their admission hospital is part of the ISARIC network) and convalescent samples post illness. These will be used to address specific questions around the impact of baseline immune function, the earliest immune responses to infection, and the biology of those who get non-hospitalized disease for local research and as a national resource. The proposal links directly with other ongoing ISARIC and community COVID projects sampling in children and the older age population. Reasonable estimates suggest the usable window for baseline sampling of NHS HCW is closing fast (e.g. baseline sampling within 3 weeks).

Detailed Description

The proposed study is a prospective observational cohort design which will be carried out across three different trusts: Barts Health NHS Trust (St Bartholomew's Hospital, The Royal London Hospital, Whipps Cross Hospital and Newham Hospital), Royal Free London NHS Foundation Trust (Royal Free Hospital) and University College London Hospitals NHS Foundation Trust (UCLH).

Participants will be asymptomatic front-facing HCWs who carry out their tasks in different areas of the corresponding hospital: Accident and Emergency, Adult Medical Admissions Unit, Medical and Surgical Wards and Intensive Care Units.

This study substantially uses existing infrastructure: Recruits into this study who are subsequently suspected to have COVID-19 can be co-recruited into ISARIC using ISARIC Ethics Ref: 13/SC/0149 (Oxford C Research Ethics Committee, UK CRN /CPMS ID 14152 IRAS ID126600 for acute samples and data collection. Sampling can be delivered via existing research personnel from furloughed projects (CLRN nurses, research fellows, Barts Bioresource). Convalescent sampling will be via an otherwise inactive Clinical Trials unit. It

Recruiting
Health Care Worker Patient Transmission
Coronavirus
Coronavirus Infections
Immunological Abnormality

Diagnostic Test: COPAN swabbing and blood sample collection
COPAN swabbing of nostrils and/or oropharynx and blood sample collection
Healthy and asymptomatic healthcare workers

Eligibility Criteria

Inclusion Criteria:

- healthy asymptomatic healthcare workers attending hospital (place of work)

Exclusion Criteria:

- SARS-CoV-2 positive or symptomatic healthcare workers

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United Kingdom
Contacts

James C Moon, MD MBBS MRCP
07570911438
bartshealth.covid-hcw@nhs.net

Mahdad Noursadeghi

James C Moon
Principal Investigator
BHC & UCL

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Charlotte Manisty
Study Director
BHC & UCL

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Thomas Treibel
Principal Investigator
Barts Heart Center

University College, London
St. Bartholomew's Hospital
Royal Free Hospital NHS Foundation Trust
UCLH
NCT Number
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome