Health Care Worker Patient TransmissionCOVID19-HCWNCT04318314
COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2
An observational study of Health Care Worker Patient Transmission and Coronavirus, run by University College, London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Care Worker Patient Transmission, Coronavirus, Coronavirus Infections
- What is being tested?
- COPAN swabbing and blood sample collection
- How many people
- 731 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 18 Mar 2020to 30 Apr 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Healthy asymptomatic healthcare workers attending their usual place of work that can be St Bartholomew's Hospital, Royal Free London or UCLH.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Mahdad Noursadeghi contact
United Kingdom2 sites, 1 recruiting
- Recruiting
Barts Heart Center
London
James Moon
James Moon
- Active, not recruiting
Royal Free London NHS Foundation Trust
London
About this study
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).
Read the 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
- Being tested
- COPAN swabbing and blood sample collection
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPAN swabbing and blood sample collectionDiagnostic test
COPAN swabbing of nostrils and/or oropharynx and blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Healthy and asymptomatic healthcare workers | Healthy and asymptomatic healthcare workers Receives: Diagnostic Test: COPAN swabbing and blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion to SARS-CoV-2 positivity
Home-isolation or hospital admission
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start18 Mar 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Health Care Worker Patient TransmissionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 731 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- St. Bartholomew's Hospital, Royal Free Hospital NHS Foundation Trust, University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- James C Moon, Principal investigator, BHC & UCLCharlotte Manisty, Study director, BHC & UCLThomas Treibel, Principal investigator, Barts Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318314
- Sponsor's protocol ID
- 130852
- Acronym
- COVID19-HCW
- Status last verified
- Feb 2022
- First submitted
- 17 Mar 2020
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of results in open access journals; sharing of results in scientific databases.
Publications
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.
PubMed 37612310Wing 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.
PubMed 37134108Doykov 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.
PubMed 35975199Astbury 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.
PubMed 35156709Valdes 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.
PubMed 33880438
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04318314
- Acronym / sponsor ID
- COVID19-HCW / 130852
- Conditions
- Health Care Worker Patient Transmission, Coronavirus, Coronavirus Infections, Immunological Abnormality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 731 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- St. Bartholomew's Hospital, Royal Free Hospital NHS Foundation Trust, University College London Hospitals
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy and asymptomatic healthcare workers | – | Diagnostic Test: COPAN swabbing and blood sample collectionHealthy and asymptomatic healthcare workers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy asymptomatic healthcare workers attending their usual place of work that can be St Bartholomew's Hospital, Royal Free London or UCLH.
Key inclusion criteria (6 listed)
- 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.
- No longer meets the inclusion/exclusion criteria if participants circumstance change
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPAN swabbing and blood sample collectionCOPAN swabbing of nostrils and/or oropharynx and blood sample collection | Diagnostic test | Healthy and asymptomatic healthcare workers |
Primary outcome
Seroconversion to SARS-CoV-2 positivity
Time frame: Within 12 months
Home-isolation or hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Derived from this study: PubMed 37612310Altmann 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.
- Derived from this study: PubMed 37134108Wing 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.
- Derived from this study: PubMed 35975199Doykov 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.
- Derived from this study: PubMed 35156709Astbury 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.
- Derived from this study: PubMed 33880438Valdes 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.
- Individual participant dataSharing planned: Yes. Publication of results in open access journals; sharing of results in scientific databases.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahdad Noursadeghi contact
James C Moon principal investigator
BHC & UCL
Charlotte Manisty study director
BHC & UCL
Thomas Treibel principal investigator
Barts Heart Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Care Worker Patient Transmission and Coronavirus, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James C Moon, MD MBBS MRCP (07570911438, bartshealth.covid-hcw@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion to SARS-CoV-2 positivity (time frame: Within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04318314, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.