COVID RESPONSE STUDY (COVRES)

NCT05548829 | Completed

• 2 other identifiers: COVRES_Ver13COVRES2
• Study Type: observational
• Target: 519
• Locations: 1 country
• Sites: 1

Brief Summary

This study will undertake recruitment of Covid-19 positive hospitalised and non-hospitalised and nursing home patients, hospital and nursing home staff, for whole genome sequencing, human host genomic analyses and viral genomic analyses. This research study will take place across three trust areas in Northern Ireland.

Conditions

COVID-19

Keywords

Covid-19; Biomarkers; Severity; Genomics

Outcome Measures

Primary Outcomes (2)

• Hospitalisation severity status

  Hospitalised and non hospitalied Covid-19 patients will be recruited onto the study for plasma and saliva biomarker assessment

  1 month

• Persistence of Covid-19 symptoms

  Determination of whether Covid-19 symptoms have changed at 3 and 6 months

  6 months

Secondary Outcomes (3)

• Immunological assessment

  6 months

• Genomic assessment

  6 months

• Flow cytometry asessment of immune cells

  6 months

Study Arms (6)

Non-hospitalised Covid-19 patients (mild infection)

COVRES1, retrospective recuitment from public advertisment, attended CTRIC or home visits. Obtained saliva and whole blood samples for DNA and RNA extraction.

Hospitalised Covid-19 patients (severe infection)

COVRES1, retrospective recuitment from secondary care, attended wards. Obtained saliva and whole blood samples for DNA and RNA extraction.

Biological: Disease severity

Non-hospitalised Covid-19 patients (mild infection) 3 month follow up

COVRES2, prospective recuitment, attended CTRIC or home visits. Obtained saliva and whole blood samples for DNA and RNA extraction.

Hospitalised Covid-19 patients (severe infection) 3 month follow up

COVRES2, prospective recuitment, attended CTRIC or home visits. Obtained saliva and whole blood samples for DNA and RNA extraction.

Biological: Disease severity

Non-hospitalised Covid-19 patients (mild infection) 6 month follow up

COVRES2, prospective recuitment, attended CTRIC or home visits. Obtained saliva and whole blood samples for DNA and RNA extraction.

Hospitalised Covid-19 patients (severe infection) 6 month follow up

COVRES2, prospective recuitment, attended CTRIC or home visits. Obtained saliva and whole blood samples for DNA and RNA extraction.

Biological: Disease severity

Interventions

Disease severity BIOLOGICAL

Observational, based on biological outcome of Covid-19 infeection. Comparing pheripheral biomakers of Covid-19 patients admitted to hospital due to infection versus Covid-19 patients that recovered at home.

Hospitalised Covid-19 patients (severe infection); Hospitalised Covid-19 patients (severe infection) 3 month follow up; Hospitalised Covid-19 patients (severe infection) 6 month follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All cohorts where recruited from the Western Health and Social Care Trust, Northern Ireland.

You may qualify if:

• Gender: Male and female
• Age: \>18
• BMI: Any
• Ethnic origin: Any
• Hospitalised, non-hospitalised and nursing home patients:
• Symptomatic/non-Symptomatic patients testing positive or suspected of being positive for COVID-19/SARS-CoV-2 by virus PCR assay
• Nursing homes caring for elderly residents
• COVID-19 wards of participating hospitals
• Hospital and nursing home staff:
• Any member of primary care, hospital or nursing home staff (including GP's) are eligible to participate whether have ever tested positive or not for COVID- 19/SARS-CoV-2 by virus PCR assay even if non-symptomatic.

You may not qualify if:

• All cohorts:
• Under 18 years of age
• Those with intellectual disabilities or mental health illness

Sponsors & Collaborators

• University of Ulster: lead
• University of Dublin, Trinity College: collaborator
• Western Health and Social Care Trust: collaborator

Study Sites (1)

Personalised Medicine Centre, School of Medicine, Ulster University, C-TRIC Building,

Londonderry, BT47 6SB, United Kingdom

Location

Related Publications (7)

• Merad M, Martin JC. Pathological inflammation in patients with COVID-19: a key role for monocytes and macrophages. Nat Rev Immunol. 2020 Jun;20(6):355-362. doi: 10.1038/s41577-020-0331-4. Epub 2020 May 6.

  PMID: 32376901 BACKGROUND

• Moons KG, Altman DG, Reitsma JB, Ioannidis JP, Macaskill P, Steyerberg EW, Vickers AJ, Ransohoff DF, Collins GS. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med. 2015 Jan 6;162(1):W1-73. doi: 10.7326/M14-0698.

  PMID: 25560730 BACKGROUND

• Ong EZ, Chan YFZ, Leong WY, Lee NMY, Kalimuddin S, Haja Mohideen SM, Chan KS, Tan AT, Bertoletti A, Ooi EE, Low JGH. A Dynamic Immune Response Shapes COVID-19 Progression. Cell Host Microbe. 2020 Jun 10;27(6):879-882.e2. doi: 10.1016/j.chom.2020.03.021. Epub 2020 Apr 30.

  PMID: 32359396 BACKGROUND

• Sun X, Wang T, Cai D, Hu Z, Chen J, Liao H, Zhi L, Wei H, Zhang Z, Qiu Y, Wang J, Wang A. Cytokine storm intervention in the early stages of COVID-19 pneumonia. Cytokine Growth Factor Rev. 2020 Jun;53:38-42. doi: 10.1016/j.cytogfr.2020.04.002. Epub 2020 Apr 25.

  PMID: 32360420 BACKGROUND

• Tay MZ, Poh CM, Renia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020 Jun;20(6):363-374. doi: 10.1038/s41577-020-0311-8. Epub 2020 Apr 28.

  PMID: 32346093 BACKGROUND

• Thevarajan I, Nguyen THO, Koutsakos M, Druce J, Caly L, van de Sandt CE, Jia X, Nicholson S, Catton M, Cowie B, Tong SYC, Lewin SR, Kedzierska K. Breadth of concomitant immune responses prior to patient recovery: a case report of non-severe COVID-19. Nat Med. 2020 Apr;26(4):453-455. doi: 10.1038/s41591-020-0819-2. No abstract available.

  PMID: 32284614 BACKGROUND

• Vardhana SA, Wolchok JD. The many faces of the anti-COVID immune response. J Exp Med. 2020 Jun 1;217(6):e20200678. doi: 10.1084/jem.20200678.

  PMID: 32353870 BACKGROUND

Related Links

• Penny Ward. COVID-19/SARS-CoV-2 Pandemic 2020.https://www.fpm.org.uk/blog/covid-19-sars-cov-2-pandemic/

Biospecimen

Retention: SAMPLES WITH DNA

COVRES1 (Case n=519); retrospective cohort. Hospitalised and Non-Hospitalised COVID-19 patients. Collecting DNA and RNA from saliva and Whole blood samples. COVRES2 (Case n=42); prospective cohort. Hospitalised and Non-Hospitalised COVID-19 patients. Three and six month follow up. Collecting DNA and RNA from saliva and Whole blood samples.

MeSH Terms

Conditions

COVID-19

Interventions

Patient Acuity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Status Indicators; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• David Gibson, PhD

  University of Ulster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 21, 2022
• Study Start: December 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 29, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)