COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2 (COVID19-HCW)

February 21, 2022 updated by: University College, London
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

731

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mahdad Noursadeghi

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Barts Heart Center
        • Contact:
          • James Moon
        • Principal Investigator:
          • James Moon
      • London, United Kingdom
        • Active, not recruiting
        • Royal Free London NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy asymptomatic healthcare workers attending their usual place of work that can be St Bartholomew's Hospital, Royal Free London or UCLH.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy and asymptomatic healthcare workers
Diagnostic test: COPAN swabbing and blood sample collection
COPAN swabbing of nostrils and/or oropharynx and blood sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion to SARS-CoV-2 positivity
Time Frame: Within 12 months
Home-isolation or hospital admission
Within 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Royal Free Hospital NHS Foundation Trust
St. Bartholomew's Hospital
UCLH

Investigators

  • Principal Investigator: James C Moon, BHC & UCL
  • Study Director: Charlotte Manisty, BHC & UCL
  • Principal Investigator: Thomas Treibel, Barts Heart Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 18, 2020

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ANTICIPATED)

April 30, 2022

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (ACTUAL)

March 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication of results in open access journals; sharing of results in scientific databases.

IPD Sharing Time Frame

24 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronavirus Infections

Clinical Trials on COPAN swabbing and blood sample collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe