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

Imperial College London

Status: Completed

Conditions: Solid Organ Transplant Recipients; Haematological Malignancies; Autoimmune Diseases

Treatments: Diagnostic Test: self-administered lateral flow assays

Study type: Observational

Funder types: Other

Identifiers

NCT05148806

MR/W029200/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28,411 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

28,411 participants in 3 patient groups

Solid organ transplant patients

Description:

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

Treatment:

Diagnostic Test: self-administered lateral flow assays

Rare autoimmune diseases

Description:

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

Treatment:

Diagnostic Test: self-administered lateral flow assays

Blood cancer

Description:

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

Treatment:

Diagnostic Test: self-administered lateral flow assays