Trial Outcomes & Findings for Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 (Covid-19) Antibodies (NCT NCT05148806)
NCT ID: NCT05148806
Last Updated: 2024-12-09
Results Overview
1\. The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post three vaccine doses will be presented.
Recruitment status
COMPLETED
Target enrollment
28411 participants
Primary outcome timeframe
21 - 90 days post 3rd vaccine
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
Solid Organ Transplant Patients
Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine
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%.
|
Rare Autoimmune Diseases
Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine
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%.
|
Blood Cancer
Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine.
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%.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12342
|
8117
|
7952
|
|
Overall Study
COMPLETED
|
9927
|
6516
|
6593
|
|
Overall Study
NOT COMPLETED
|
2415
|
1601
|
1359
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
16 participants did not report their gender.
Baseline characteristics by cohort
| Measure |
Solid Organ Transplant Patients
n=9927 Participants
Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine
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%.
|
Rare Autoimmune Diseases
n=6516 Participants
Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine
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%.
|
Blood Cancer-Lymphoid Malignancy
n=6593 Participants
Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine.
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%.
|
Total
n=23036 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=9927 Participants
|
62 years
n=6516 Participants
|
59 years
n=6593 Participants
|
NA years
n=23036 Participants
|
|
Sex: Female, Male
Gender · Female
|
4494 Participants
n=9920 Participants • 16 participants did not report their gender.
|
5070 Participants
n=6509 Participants • 16 participants did not report their gender.
|
2971 Participants
n=6591 Participants • 16 participants did not report their gender.
|
12535 Participants
n=23020 Participants • 16 participants did not report their gender.
|
|
Sex: Female, Male
Gender · Male
|
5426 Participants
n=9920 Participants • 16 participants did not report their gender.
|
1439 Participants
n=6509 Participants • 16 participants did not report their gender.
|
3620 Participants
n=6591 Participants • 16 participants did not report their gender.
|
10485 Participants
n=23020 Participants • 16 participants did not report their gender.
|
|
Race/Ethnicity, Customized
White
|
9268 Participants
n=9927 Participants
|
5992 Participants
n=6516 Participants
|
6401 Participants
n=6593 Participants
|
21661 Participants
n=23036 Participants
|
|
Race/Ethnicity, Customized
Asian
|
351 Participants
n=9927 Participants
|
231 Participants
n=6516 Participants
|
73 Participants
n=6593 Participants
|
655 Participants
n=23036 Participants
|
|
Race/Ethnicity, Customized
Black
|
134 Participants
n=9927 Participants
|
130 Participants
n=6516 Participants
|
38 Participants
n=6593 Participants
|
302 Participants
n=23036 Participants
|
|
Race/Ethnicity, Customized
Other
|
133 Participants
n=9927 Participants
|
142 Participants
n=6516 Participants
|
64 Participants
n=6593 Participants
|
339 Participants
n=23036 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
41 Participants
n=9927 Participants
|
21 Participants
n=6516 Participants
|
17 Participants
n=6593 Participants
|
79 Participants
n=23036 Participants
|
|
Region of Enrollment
United Kingdom
|
9927 participants
n=9927 Participants
|
6516 participants
n=6516 Participants
|
6593 participants
n=6593 Participants
|
23036 participants
n=23036 Participants
|
|
Total number of vaccines at time of test
3 vaccines
|
2700 Participants
n=9927 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
2615 Participants
n=6516 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
1268 Participants
n=6593 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
6583 Participants
n=23036 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
|
Total number of vaccines at time of test
4 vaccines
|
6046 Participants
n=9927 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
3531 Participants
n=6516 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
4657 Participants
n=6593 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
14234 Participants
n=23036 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
|
Total number of vaccines at time of test
5+ vaccines
|
1181 Participants
n=9927 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
370 Participants
n=6516 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
668 Participants
n=6593 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
2219 Participants
n=23036 Participants • Rows added for 3, 4, 5+ vaccines at time of test
|
PRIMARY outcome
Timeframe: 21 - 90 days post 3rd vaccinePopulation: Patients who have received 3 vaccines
1\. The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post three vaccine doses will be presented.
Outcome measures
| Measure |
Solid Organ Transplant Patients
n=2700 Participants
Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine
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%.
|
Rare Autoimmune Diseases
n=2615 Participants
Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine
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%.
|
Blood Cancer
n=1268 Participants
Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine.
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%.
|
|---|---|---|---|
|
The Proportion of Participants With and Without Antibodies to SARS-CoV-2
Antibody Negative
|
875 Participants
|
378 Participants
|
277 Participants
|
|
The Proportion of Participants With and Without Antibodies to SARS-CoV-2
Antibody Positive
|
1825 Participants
|
2237 Participants
|
991 Participants
|
PRIMARY outcome
Timeframe: 21 - 90 days post 4th vaccinePopulation: Patients who have received 4 vaccines
1\. The proportion of participants with and without antibodies to SARS-CoV-2 at 21 - 90 days post four vaccine doses will be presented.
Outcome measures
| Measure |
Solid Organ Transplant Patients
n=6046 Participants
Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine
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%.
|
Rare Autoimmune Diseases
n=3531 Participants
Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine
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%.
|
Blood Cancer
n=4657 Participants
Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine.
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%.
|
|---|---|---|---|
|
The Proportion of Participants With and Without Antibodies to SARS-CoV-2
Antibody Negative
|
1242 Participants
|
507 Participants
|
1006 Participants
|
|
The Proportion of Participants With and Without Antibodies to SARS-CoV-2
Antibody Positive
|
4804 Participants
|
3024 Participants
|
3651 Participants
|
PRIMARY outcome
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 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
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 by 6 months will be presented for those with and without antibodies to SARS-CoV-2 following 3rd or 4th vaccine
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Antibodies at 21 - 90 days after 3rd or 4th vaccinePopulation: 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.
Outcome measures
| Measure |
Solid Organ Transplant Patients
n=9927 Participants
Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine
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%.
|
Rare Autoimmune Diseases
n=6516 Participants
Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine
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%.
|
Blood Cancer
n=6593 Participants
Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine.
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%.
|
|---|---|---|---|
|
Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine
Antibody Negative after 3 vaccines
|
875 participants who received vaccines
|
378 participants who received vaccines
|
277 participants who received vaccines
|
|
Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine
Antibody Positive after 3 vaccines
|
1825 participants who received vaccines
|
2237 participants who received vaccines
|
991 participants who received vaccines
|
|
Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine
Antibody Negative after 4 vaccines
|
1242 participants who received vaccines
|
507 participants who received vaccines
|
1006 participants who received vaccines
|
|
Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine
Antibody Positive after 4 vaccines
|
4804 participants who received vaccines
|
3024 participants who received vaccines
|
3651 participants who received vaccines
|
|
Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine
Antibody Negative after 5+ vaccines
|
193 participants who received vaccines
|
37 participants who received vaccines
|
83 participants who received vaccines
|
|
Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine
Antibody Positive after 5+ vaccines
|
988 participants who received vaccines
|
333 participants who received vaccines
|
585 participants who received vaccines
|
Adverse Events
Solid Organ Transplant Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rare Autoimmune Diseases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Blood Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gillian Powter Trial Manager
NHS Blood and Transplant
Phone: 44 7590 353091
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place