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 forSARS-CoV-2 and the disease COVID-19. A customized disease specific understanding will beimportant to understand subsequent disease waves, vaccine development and therapeutics.For this reason, ISARIC (the International Severe Acute Respiratory and EmergingInfection Consortium) was set up in advance. This focuses on hospitalised andconvalescent 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 immunestatus and the earliest immune changes that may occur in mild disease to compare withthose of SARS-CoV-2. There is also a need to understand the vulnerability and response toCOVID-19 of the NHS workforce of healthcare workers (HCWs). HCW present a cohort withlikely higher exposure and seroconversion rates than the general population, but who canbe followed up with potential for serial testing enabling an insight into early diseaseand markers of risk for disease severity. We have set up "COVID-19: Healthcare workerBioresource: Immune Protection and Pathogenesis in SARS-CoV-2". This urgent fieldworkaims to secure significant (n=400) sampling of healthcare workers (demographics, swabs,blood sampling) at baseline, and weekly whilst they are well and attending work, withacute sampling (if hospitalised, via ISARIC, if their admission hospital is part of theISARIC network) and convalescent samples post illness. These will be used to addressspecific questions around the impact of baseline immune function, the earliest immuneresponses to infection, and the biology of those who get non-hospitalized disease forlocal research and as a national resource. The proposal links directly with other ongoingISARIC and community COVID projects sampling in children and the older age population.Reasonable estimates suggest the usable window for baseline sampling of NHS HCW isclosing 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

Unknown status
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

Eligibility Criteria

Inclusion Criteria:

- Age at least 18 years AND

- Asymptomatic (meaning healthy enough to attend work according to Trust policy at the
time) AND

- Work in the designated clinical environments for at least 5 hours for at least one
day during the study period.

Participants will be free to withdraw from the study at any point, but collection of
these data is considered to be in the public interest and will fall under the scope of a
'Public task' by the GDPR definition. Under these conditions rights to erasure and data
portability do not apply, and archiving and further processing for scientific research
purposes is compatible with the original purpose; no further participant data from
medical records will be collected.

The research team may withdraw a participant from the study in the following situations:

- No longer meets the inclusion/exclusion criteria if participants circumstance change

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Kingdom
Locations

Barts Heart Center
London, United Kingdom

Royal Free London NHS Foundation Trust
London, United Kingdom

Contacts

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

Mahdad Noursadeghi

University College, London
NCT Number
MeSH Terms
Coronavirus Infections