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

Autoimmune Diseases Clinical Trial

— MELODY  

Official title:

Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 Antibody Responses in Immunosuppressed People (The MELODY Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148806
• Other study ID #: MR/W029200/1
• Status: Completed
• Start date: December 7, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28411
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Autoimmune Diseases
• Haematological Malignancies
• Hematologic Neoplasms
• Neoplasms
• Solid Organ Transplant Recipients

Intervention

Diagnostic Test:
• self-administered lateral flow assays
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%.

Locations

Country	Name	City	State
United Kingdom	NHS Blood and Transplant	Bristol
United Kingdom	Imperial College	London
United Kingdom	Ipsos Mori	London
United Kingdom	National Disease Registration Service	London

Sponsors (5)

Lead Sponsor	Collaborator
Imperial College London	IPSOS, NHS Blood and Transplant, Nottingham University Hospitals NHS Trust, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 four vaccine doses will be presented.	21 - 90 days post 4th vaccine
Primary	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
Primary	The incidence of participants hospitalised due to COVID-19 and deaths due to COVID-19 by 6 months.	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, and compared as described above if there are sufficient events.	6 month follow-up period from registration
Primary	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