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Completed

NCT Number: NCT05148806

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

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.

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Key information

Conditions

Solid Organ Transplant Recipients Autoimmune Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Haematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Infections Lung Diseases Neoplasms Neoplasms by Site Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Blood and Transplant, Bristol, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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) -

Exclusion criteria

-

Treatment and study plan

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%.

Primary outcomes

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

    Time frame: 21 - 90 days post 3rd vaccine

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

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

    Time frame: 21 - 90 days post 4th vaccine

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

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

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • IPSOS
  • NHS Blood and Transplant
  • Nottingham University Hospitals NHS Trust
  • University of Nottingham

Registry information

Official study title

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

Acronym: MELODY

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 8, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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