CompletedNot Applicable

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

United Kingdom28,411 participantsStarted 2021-12-07

Plain-language 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. A solid organ transplant recipient (n=12,000)
. Patients with a rare autoimmune disease (n=12,000)
. Patients with lymphoid malignancies (n=12,000) -

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 21 - 90 days post 3rd vaccine

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Antibodies at 21 - 90 days after 3rd or 4th vaccine

Trial details

NCT IDNCT05148806

SponsorImperial College London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-30

Results submitted2024-01-09

View on ClinicalTrials.gov More Solid Organ Transplant Recipients trials

Plain-language summary

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. A solid organ transplant recipient (n=12,000)
. Patients with a rare autoimmune disease (n=12,000)
. Patients with lymphoid malignancies (n=12,000) -

What they're measuring

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

Timeframe: 21 - 90 days post 3rd vaccine

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Antibodies at 21 - 90 days after 3rd or 4th vaccine