CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28,411 enrolled
Drug / intervention
self-administered lateral flow assaysother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05148806
NCT05148806N/ACompleted
CompareCT.gov

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

Imperial College London·observational·Posted Dec 8, 2021·Updated Dec 9, 2024

In Brief

An observational study evaluating self-administered lateral flow assays for Solid Organ Transplant Recipients and 2 related conditions. Completed, enrolled 28,411 participants across 4 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Organ Transplant Recipients, Autoimmune Diseases, Haematological Malignancies
CountriesUnited Kingdom
CollaboratorsNHS Blood and Transplant, IPSOS, University of Nottingham, Nottingham University Hospitals NHS Trust

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 8, 2021
Enrollment StartDec 7, 2021
Primary CompletionDec 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.6 years ago

Interventions

self-administered lateral flow assaysother

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%.