Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 (Covid-19) Antibodies

NCT05148806 | Completed Results

• 1 other identifier: MR/W029200/1
• Study Type: observational
• Target: 28,411
• Locations: 1 country
• Sites: 4

Brief Summary

DESIGN Observational epidemiological study AIMS - To determine:

1. 1.The proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the demographic, disease, and treatment characteristics that influence antibody status.
2. 2.If the detection of antibodies inversely correlates with subsequent risk of severe acute respiratory syndrome coronavirus-2 infection and/or severity of disease in immunosuppressed people.

Conditions

Solid Organ Transplant Recipients; Autoimmune Diseases; Haematological Malignancies

Keywords

Antibody testing; SARS-COV-2; Covid-19; Immunosuppression; solid organ transplant; haematological malignancy; blood cancer; autoimmune disease

Outcome Measures

Primary Outcomes (5)

• The Proportion of Participants With and Without Antibodies to SARS-CoV-2

  1\. The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post three vaccine doses will be presented.

  21 - 90 days post 3rd vaccine

• The Proportion of Participants With and Without Antibodies to SARS-CoV-2

  1\. The proportion of participants with and without antibodies to SARS-CoV-2 at 21 - 90 days post four vaccine doses will be presented.

  21 - 90 days post 4th vaccine

• The Incidence of Participants Having at Least One RT-qPCR Proven Infection in the 6-month Follow-up Period After 3rd or 4th Vaccine

  The incidence of participants having at least one RT-qPCR proven infection in the 6-month follow-up will be presented for those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine.

  6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies.

• The Incidence of Participants Hospitalised Due to COVID-19 and Deaths Due to COVID-19

  The incidence of participants hospitalised due to COVID-19 and deaths due to COVID-19 by 6 months will be presented for those with and without antibodies to SARS-CoV-2 following 3rd or 4th vaccine

  6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies.

• Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine

  Rates of those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine will be presented for different clinical characteristics and sociodemographic factors.

  Antibodies at 21 - 90 days after 3rd or 4th vaccine

Study Arms (3)

Solid organ transplant patients

Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine

Diagnostic Test: self-administered lateral flow assays

Rare autoimmune diseases

Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine

Diagnostic Test: self-administered lateral flow assays

Blood cancer

Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine.

Diagnostic Test: self-administered lateral flow assays

Interventions

self-administered lateral flow assays DIAGNOSTIC_TEST

The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%.

Blood cancer; Rare autoimmune diseases; Solid organ transplant patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Any adult, or young person over 12 years old, with a functioning transplant who has received at least 3 vaccines, will be eligible to participate. 2. People with rare autoimmune diseases, many of whom are on immunosuppressants, have validated disease diagnoses, and those treated with Rituximab who are most at risk of lack of seroconversion following COVID-19 vaccination. 3. People ≥18 years of age with a haematological malignancy who have received at least 3 vaccines will be eligible.

You may qualify if:

• Adults and young people over 12 years of age, and are classified as being part of one of the following patient groups:
• A solid organ transplant recipient (n=12,000)
• Patients with a rare autoimmune disease (n=12,000)
• Patients with lymphoid malignancies (n=12,000) -

Sponsors & Collaborators

• Imperial College London: lead
• NHS Blood and Transplant: collaborator
• IPSOS: collaborator
• University of Nottingham: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (4)

NHS Blood and Transplant

Bristol, United Kingdom

Location

Imperial College

London, United Kingdom

Location

Ipsos Mori

London, United Kingdom

Location

National Disease Registration Service

London, United Kingdom

Location

Related Links

• Published results

MeSH Terms

Conditions

Autoimmune Diseases; COVID-19; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

1.Participation required self-engagement 2. We used a non-quantitative test without distinguishing between absent \& very low anti-SARS-CoV-2 IgG antibody concentrations nor antigen-specific T-cell responses 3.Covariates selected for the analysis were based on data captured via the research questionnaire that were clinically appropriate 4.Data processing approvals meant a single intracohort comparison analysis wasn't possible,but similar methodology \& analysis was applied to the different cohorts

Results Point of Contact

• Title: Gillian Powter Trial Manager
• Organization: NHS Blood and Transplant

gillian.powter@nhsbt.nhs.uk

44 7590 353091

Study Officials

• Michelle Willicombe, MBBS, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 8, 2021
• Study Start: December 7, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)