Solid Organ Transplant RecipientsMELODYNCT05148806
Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 (Covid-19) Antibodies
An observational study of Solid Organ Transplant Recipients and Autoimmune Diseases, run by Imperial College London at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Solid Organ Transplant Recipients, Autoimmune Diseases, Haematological Malignancies
- What is being tested?
- self-administered lateral flow assays
- Type of treatment
- Vaccines
- How many people
- 28,411 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 7 Dec 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Any adult, or young person over 12 years old, with a functioning transplant who has received at least 3 vaccines, will be eligible to participate. 2. People with rare autoimmune diseases, many of whom are on immunosuppressants, have validated disease diagnoses, and those treated with Rituximab who are most at risk of lack of seroconversion following COVID-19 vaccination. 3. People ≥18 years of age with a haematological malignancy who have received at least 3 vaccines will be eligible.
Who may be able to join
- 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) -
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
NHS Blood and Transplant
Bristol
Imperial College
London
Ipsos Mori
London
National Disease Registration Service
London
About this study
Official title: Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 Antibody Responses in Immunosuppressed People (The MELODY Study)
DESIGN Observational epidemiological study
AIMS - To determine:
- 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.
- 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.
Read the 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.
- Being tested
- self-administered lateral flow assays
- Keywords
- Antibody testing, SARS-COV-2, Covid-19, Immunosuppression, solid organ transplant, haematological malignancy, blood cancer, autoimmune disease
- Medical subject headings
- Autoimmune Diseases, COVID-19, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered lateral flow assaysDiagnostic 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%.
| Study group | Role | What they receive |
|---|---|---|
| Solid organ transplant patients | Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine Receives: Diagnostic Test: self-administered lateral flow assays | |
| Rare autoimmune diseases | Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine Receives: Diagnostic Test: self-administered lateral flow assays | |
| Blood cancer | Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine. Receives: Diagnostic Test: self-administered lateral flow assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Participants With and Without Antibodies to SARS-CoV-2
- The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post three vaccine doses will be presented.
Measured: 21 - 90 days post 3rd vaccine
The Proportion of Participants With and Without Antibodies to SARS-CoV-2
- The proportion of participants with and without antibodies to SARS-CoV-2 at 21 - 90 days post four vaccine doses will be presented.
Measured: 21 - 90 days post 4th vaccine
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.
Measured: 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
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
Measured: 6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies.
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.
Measured: Antibodies at 21 - 90 days after 3rd or 4th vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start7 Dec 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid Organ Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Blood and Transplant, IPSOS, University of Nottingham, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Michelle Willicombe, MBBS, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148806
- Sponsor's protocol ID
- MR/W029200/1
- Acronym
- MELODY
- Status last verified
- Oct 2024
- First submitted
- 6 Dec 2021
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 Antibody Responses in Immunosuppressed People (The MELODY Study)
- ClinicalTrials.gov ID
- NCT05148806
- Acronym / sponsor ID
- MELODY / MR/W029200/1
- Keywords
- Antibody testing, SARS-COV-2, Covid-19, Immunosuppression, solid organ transplant, haematological malignancy, blood cancer, autoimmune disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,411 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- NHS Blood and Transplant, IPSOS, University of Nottingham, Nottingham University Hospitals NHS Trust
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DESIGN Observational epidemiological study
AIMS - To determine:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Solid organ transplant patients | – | Diagnostic Test: self-administered lateral flow assaysPatients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine |
| Rare autoimmune diseases | – | Diagnostic Test: self-administered lateral flow assaysPatients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine |
| Blood cancer | – | Diagnostic Test: self-administered lateral flow assaysPatients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Any adult, or young person over 12 years old, with a functioning transplant who has received at least 3 vaccines, will be eligible to participate. 2. People with rare autoimmune diseases, many of whom are on immunosuppressants, have validated disease diagnoses, and those treated with Rituximab who are most at risk of lack of seroconversion following COVID-19 vaccination. 3. People ≥18 years of age with a haematological malignancy who have received at least 3 vaccines will be eligible.
Key inclusion criteria (4 listed)
- 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) -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-administered lateral flow assaysThe 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%. | Diagnostic test | Blood cancer, Rare autoimmune diseases, Solid organ transplant patients |
Primary outcome
The Proportion of Participants With and Without Antibodies to SARS-CoV-2
Time frame: 21 - 90 days post 3rd vaccine
1. The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post three vaccine doses will be presented.
The Proportion of Participants With and Without Antibodies to SARS-CoV-2
Time frame: 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
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.
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Published resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Willicombe, MBBS, MD principal investigator
Imperial College London
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Organ Transplant Recipients and Autoimmune Diseases, run by Imperial College London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Participants With and Without Antibodies to SARS-CoV-2 (time frame: 21 - 90 days post 3rd vaccine). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.