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

NCT ID: NCT04318314

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 731 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-18
• Study Completion Date: 2022-04-30

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy and asymptomatic healthcare workers

Healthy and asymptomatic healthcare workers

COPAN swabbing and blood sample collection

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

COPAN swabbing and blood sample collection

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

Intervention Type: DIAGNOSTIC_TEST

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:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Bartholomew's Hospital

OTHER

Sponsor Role: collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

UCLH

UNKNOWN

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James C Moon

Role: PRINCIPAL_INVESTIGATOR

BHC & UCL

Charlotte Manisty

Role: STUDY_DIRECTOR

BHC & UCL

Thomas Treibel

Role: PRINCIPAL_INVESTIGATOR

Barts Heart Center

Locations

Barts Heart Center

London, , United Kingdom

Site Status: RECRUITING

Royal Free London NHS Foundation Trust

London, , United Kingdom

Site Status: ACTIVE_NOT_RECRUITING

Countries

United Kingdom

Central Contacts

James C Moon, MD MBBS MRCP

Role: CONTACT

bartshealth.covid-hcw@nhs.net

07570911438

Mahdad Noursadeghi

Role: CONTACT

Facility Contacts

James Moon

Role: primary

References

Altmann DM, Reynolds CJ, Joy G, Otter AD, Gibbons JM, Pade C, Swadling L, Maini MK, Brooks T, Semper A, McKnight A, Noursadeghi M, Manisty C, Treibel TA, Moon JC; COVIDsortium investigators; Boyton RJ. Persistent symptoms after COVID-19 are not associated with differential SARS-CoV-2 antibody or T cell immunity. Nat Commun. 2023 Aug 23;14(1):5139. doi: 10.1038/s41467-023-40460-1.

Reference Type: DERIVED

PMID: 37612310 (View on PubMed)

Wing PAC, Schmidt NM, Peters R, Erdmann M, Brown R, Wang H, Swadling L; COVIDsortium Investigators; Newman J, Thakur N, Shionoya K, Morgan SB, Hinks TS, Watashi K, Bailey D, Hansen SB, Davidson AD, Maini MK, McKeating JA. An ACAT inhibitor suppresses SARS-CoV-2 replication and boosts antiviral T cell activity. PLoS Pathog. 2023 May 3;19(5):e1011323. doi: 10.1371/journal.ppat.1011323. eCollection 2023 May.

Reference Type: DERIVED

PMID: 37134108 (View on PubMed)

Doykov I, Baldwin T, Spiewak J, Gilmour KC, Gibbons JM, Pade C, Reynolds CJ, Aine McKnight, Noursadeghi M, Maini MK, Manisty C, Treibel T, Captur G, Fontana M, Boyton RJ, Altmann DM, Brooks T, Semper A; UK COVIDsortium Investigators; Moon JC, Kevin Mills, Heywood WE. Quantitative, multiplexed, targeted proteomics for ascertaining variant specific SARS-CoV-2 antibody response. Cell Rep Methods. 2022 Sep 19;2(9):100279. doi: 10.1016/j.crmeth.2022.100279. Epub 2022 Aug 12.

Reference Type: DERIVED

PMID: 35975199 (View on PubMed)

Astbury S, Reynolds CJ, Butler DK, Munoz-Sandoval DC, Lin KM, Pieper FP, Otter A, Kouraki A, Cusin L, Nightingale J, Vijay A, Craxford S, Aithal GP, Tighe PJ, Gibbons JM, Pade C, Joy G, Maini M, Chain B, Semper A, Brooks T, Ollivere BJ, McKnight A, Noursadeghi M, Treibel TA, Manisty C, Moon JC; COVIDsortium Investigators*; Valdes AM, Boyton RJ, Altmann DM. HLA-DR polymorphism in SARS-CoV-2 infection and susceptibility to symptomatic COVID-19. Immunology. 2022 May;166(1):68-77. doi: 10.1111/imm.13450. Epub 2022 Mar 8.

Reference Type: DERIVED

PMID: 35156709 (View on PubMed)

Valdes AM, Moon JC, Vijay A, Chaturvedi N, Norrish A, Ikram A, Craxford S, Cusin LML, Nightingale J, Semper A, Brooks T, McKnight A, Kurdi H, Menni C, Tighe P, Noursadeghi M, Aithal G, Treibel TA, Ollivere BJ, Manisty C. Longitudinal assessment of symptoms and risk of SARS-CoV-2 infection in healthcare workers across 5 hospitals to understand ethnic differences in infection risk. EClinicalMedicine. 2021 Apr;34:100835. doi: 10.1016/j.eclinm.2021.100835. Epub 2021 Apr 15.

Reference Type: DERIVED

PMID: 33880438 (View on PubMed)

Provided Documents

Document Type: Study Protocol: List of Publications

View Document

Document Type: Study Protocol: Last Amendment N 4 - Description and Approval Letter

View Document

Document Type: Study Protocol: Full Study Protocol Updated 21/09/2020

View Document

Other Identifiers

130852

Identifier Type: -

Identifier Source: org_study_id