COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2

NCT04318314 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 731

Last updated 2022-02-22

No results posted yet for this study

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).

Conditions

  • Health Care Worker Patient Transmission
  • Coronavirus
  • Coronavirus Infections
  • Immunological Abnormality

Interventions

DIAGNOSTIC_TEST

COPAN swabbing and blood sample collection

COPAN swabbing of nostrils and/or oropharynx and blood sample collection

Sponsors & Collaborators

  • St. Bartholomew's Hospital

    collaborator OTHER
  • Royal Free Hospital NHS Foundation Trust

    collaborator OTHER
  • UCLH

    collaborator UNKNOWN
  • University College, London

    lead OTHER

Principal Investigators

  • James C Moon · BHC & UCL

  • Charlotte Manisty · BHC & UCL

  • Thomas Treibel · Barts Heart Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2021-04-30
Completion
2022-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04318314 on ClinicalTrials.gov