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

NCT04318314 | Unknown DMC

• 1 other identifier: 130852
• Study Type: observational
• Target: 731
• Locations: 1 country
• Sites: 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Seroconversion to SARS-CoV-2 positivity

  Home-isolation or hospital admission

  Within 12 months

Study Arms (1)

Healthy and asymptomatic healthcare workers

Healthy and asymptomatic healthcare workers

Diagnostic Test: COPAN swabbing and blood sample collection

Interventions

COPAN swabbing and blood sample collection DIAGNOSTIC_TEST

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

Healthy and asymptomatic healthcare workers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:

Sponsors & Collaborators

• University College, London: lead
• St. Bartholomew's Hospital: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• UCLH: collaborator

Study Sites (2)

Barts Heart Center

London, United Kingdom

RECRUITING

Royal Free London NHS Foundation Trust

London, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (5)

• 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.

  PMID: 37612310 DERIVED

• 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.

  PMID: 37134108 DERIVED

• 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.

  PMID: 35975199 DERIVED

• 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.

  PMID: 35156709 DERIVED

• 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.

  PMID: 33880438 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Nasal and oropharygeal swabs Saliva samples

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• James C Moon

  BHC & UCL

  PRINCIPAL INVESTIGATOR

• Charlotte Manisty

  BHC & UCL

  STUDY DIRECTOR

• Thomas Treibel

  Barts Heart Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James C Moon, MD MBBS MRCP

CONTACT

07570911438; bartshealth.covid-hcw@nhs.net

Mahdad Noursadeghi

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 23, 2020
• Study Start: March 18, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 24 months

Locations

GB (2)