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

Completed

• Conditions: Solid Organ Transplant Recipients; Haematological Malignancies; Autoimmune Diseases
• Interventions: Diagnostic Test: self-administered lateral flow assays

• Registration Number: NCT05148806
• Lead Sponsor: Imperial College London

Brief Summary

DESIGN Observational epidemiological study

AIMS - To determine:

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. 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.

Detailed Description

The aim of this proposal is to assess at a population level; 1) the proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the sociodemographic, disease, and treatment characteristics that influence antibody status; 2) if the detection of antibodies inversely correlates with subsequent risk of SARS-CoV2 infection and/or severity of disease in immunosuppressed individuals.

The investigators aim to target patient groups least likely to mount an immune response to vaccination; a) solid organ transplant recipients; b) patients with a rare autoimmune disease c) patients with haematological malignancies, specifically lymphoid malignancies. The investigators will use comprehensive registries to identify and recruit patients from these groups, and utilise the existing linkages these registries already have to obtain COVID-19 outcome information.

The investigators hypothesise that a sizeable proportion of immunosuppressed people will have no detectable SARS-CoV-2 antibodies following a three vaccine doses, and that this cohort is particularly susceptible to SARS-CoV-2 infection and death.

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-06
• Study Start: 2021-12-07
• Study First Posted: 2021-12-08
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Results First Submitted: 2024-01-09
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Results First Posted: 2024-12-09
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28411

Inclusion Criteria

Adults and young people over 12 years of age, and are classified as being part of one of the following patient groups:

1. A solid organ transplant recipient (n=12,000)
2. Patients with a rare autoimmune disease (n=12,000)
3. Patients with lymphoid malignancies (n=12,000) -

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood cancer	self-administered lateral flow assays	Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine.
Solid organ transplant patients	self-administered lateral flow assays	Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine
Rare autoimmune diseases	self-administered lateral flow assays	Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine

Primary Outcome Measures

Name	Time	Method
The Proportion of Participants With and Without Antibodies to SARS-CoV-2	21 - 90 days post 4th vaccine	1. The proportion of participants with and without antibodies to SARS-CoV-2 at 21 - 90 days post four vaccine doses will be presented.
The Incidence of Participants Having at Least One RT-qPCR Proven Infection in the 6-month Follow-up Period 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 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.
The Incidence of Participants Hospitalised Due to COVID-19 and Deaths Due to COVID-19	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 by 6 months will be presented for those with and without antibodies to SARS-CoV-2 following 3rd or 4th vaccine
Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine	Antibodies at 21 - 90 days 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.

Trial Locations

Locations (4)

Ipsos Mori; 🇬🇧 London, United Kingdom

National Disease Registration Service; 🇬🇧 London, United Kingdom

NHS Blood and Transplant; 🇬🇧 Bristol, United Kingdom

Imperial College; 🇬🇧 London, United Kingdom