Trial Outcomes & Findings for Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19) (NCT NCT04427280)
NCT ID: NCT04427280
Last Updated: 2025-09-04
Results Overview
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) (spike-protein). Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol.
COMPLETED
153 participants
Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
2025-09-04
Participant Flow
163 patients were recruited in the trial: 11 in Arm A and 152 in Arm B. Of the 11 patients recruited to Arm A, only one patient tested positive for COVID-19 (Coronavirus Disease 2019) at baseline and so was eligible for analysis.
Participant milestones
| Measure |
Arm A
Suspected acute COVID-19 infection
Throat/nose swabs: Throat/nose swabs will initially be collected at baseline (D0) as part of the diagnostic workup for SARS-CoV-2 infection. Subsequent throat/nose swabs will be taken at D7 (if an inpatient), D14, D28, D42 and D56. Two samples will be taken, one for standard of care testing and one for lateral flow assay and storage for further analysis later such as quantitative PCR.
Saliva collection: Saliva will be collected at each study visit, by asking the participant to provide a small amount of saliva (approximately 0.5mL) will be collected. Saliva will be tested by the lateral flow assay when available and excess material stored.
Blood collection: Approximately 30mL of blood will be taken at each study visit.
|
Arm B
Asymptomatic patients with no clinical suspicion of COVID-19
Blood collection: Approximately 30mL of blood will be taken at each study visit.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
152
|
|
Overall Study
COMPLETED
|
1
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Arm A
Suspected acute COVID-19 infection
Throat/nose swabs: Throat/nose swabs will initially be collected at baseline (D0) as part of the diagnostic workup for SARS-CoV-2 infection. Subsequent throat/nose swabs will be taken at D7 (if an inpatient), D14, D28, D42 and D56. Two samples will be taken, one for standard of care testing and one for lateral flow assay and storage for further analysis later such as quantitative PCR.
Saliva collection: Saliva will be collected at each study visit, by asking the participant to provide a small amount of saliva (approximately 0.5mL) will be collected. Saliva will be tested by the lateral flow assay when available and excess material stored.
Blood collection: Approximately 30mL of blood will be taken at each study visit.
|
Arm B
Asymptomatic patients with no clinical suspicion of COVID-19
Blood collection: Approximately 30mL of blood will be taken at each study visit.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
Baseline characteristics by cohort
| Measure |
Arm A
n=1 Participants
Suspected acute COVID-19 infection
Throat/nose swabs: Throat/nose swabs will initially be collected at baseline (D0) as part of the diagnostic workup for SARS-CoV-2 infection. Subsequent throat/nose swabs will be taken at D7 (if an inpatient), D14, D28, D42 and D56. Two samples will be taken, one for standard of care testing and one for lateral flow assay and storage for further analysis later such as quantitative PCR.
Saliva collection: Saliva will be collected at each study visit, by asking the participant to provide a small amount of saliva (approximately 0.5mL) will be collected. Saliva will be tested by the lateral flow assay when available and excess material stored.
Blood collection: Approximately 30mL of blood will be taken at each study visit.
|
Arm B
n=152 Participants
Asymptomatic patients with no clinical suspicion of COVID-19
Blood collection: Approximately 30mL of blood will be taken at each study visit.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
66 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caribbean
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
152 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Anatomical site of malignancy
Colorectal
|
0 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Anatomical site of malignancy
Oesophagogastric
|
0 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Anatomical site of malignancy
Hepato pancreatic biliary
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Anatomical site of malignancy
Other
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients who had at least one blood test taken during the study. Patients were included in the analysis at each timepoint if they had available assay results at that timepoint. The analysis was restricted to Arm B patients, as antibody test results were not available for the eligible Arm A patient.
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) (spike-protein). Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol.
Outcome measures
| Measure |
Arm B
n=146 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).
Spike-protein antibodies: Day 0
|
34.9 Percentage of patients
Interval 27.2 to 43.3
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).
Spike-protein antibodies: Day 28
|
38.3 Percentage of patients
Interval 29.8 to 47.3
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).
Spike-protein antibodies: Day 56
|
52.7 Percentage of patients
Interval 43.0 to 62.2
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).
Spike-protein antibodies: Day 84
|
61.9 Percentage of patients
Interval 51.9 to 71.2
|
—
|
PRIMARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients who had at least one blood test taken during the study. Patients were included in the analysis at each timepoint if they had available assay results at that timepoint. The analysis was restricted to Arm B patients, as antibody test results were not available for the eligible Arm A patient.
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (nucleocapsid). Nucleocapsid (anti-N) antibodies were analysed with the Elecsys SARS-CoV-2 assay on a Cobas analyser (Roche). As specified by the manufacturer, values above a cut-off index (COI) ≥ 1.0 were reported as positive.
Outcome measures
| Measure |
Arm B
n=150 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid).
Nucleocapsid antibodies: Day 0
|
14.7 Percentage of patients
Interval 9.4 to 21.4
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid).
Nucleocapsid antibodies: Day 28
|
14.0 Percentage of patients
Interval 8.5 to 21.2
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid).
Nucleocapsid antibodies: Day 56
|
16.1 Percentage of patients
Interval 9.8 to 24.2
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid).
Nucleocapsid antibodies: Day 84
|
14.3 Percentage of patients
Interval 8.2 to 22.5
|
—
|
PRIMARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients were included in the analysis at each timepoint if they had available assay results across all blood sample timepoints (Day 0, Day 28, Day 56, Day 84). The analysis was restricted to Arm B patients, as antibody test results were not available for the eligible Arm A patient.
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (spike-protein). Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol.
Outcome measures
| Measure |
Arm B
n=78 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84)
Spike-protein antibodies: Day 0
|
34.6 Percentage of patients
Interval 24.2 to 46.2
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84)
Spike-protein antibodies: Day 28
|
41 Percentage of patients
Interval 30.0 to 52.7
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84)
Spike-protein antibodies: Day 56
|
50 Percentage of patients
Interval 38.5 to 61.5
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84)
Spike-protein antibodies: Day 84
|
60.3 Percentage of patients
Interval 48.5 to 71.2
|
—
|
PRIMARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients were included in the analysis at each timepoint if they had available assay results at all blood sample timepoints (Day 0, Day 28, Day 56, Day 84). The analysis was restricted to Arm B patients, as antibody test results were not available for the eligible Arm A patient.
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (nucleocapsid). Nucleocapsid (anti-N) antibodies were analysed with the Elecsys SARS-CoV-2 assay on a Cobas analyser (Roche). As specified by the manufacturer, values above a cut-off index (COI) ≥ 1.0 were reported as positive.
Outcome measures
| Measure |
Arm B
n=80 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84)
Nucleocapsid antibodies: Day 0
|
12.5 Percentage of patients
Interval 6.2 to 21.8
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84)
Nucleocapsid antibodies: Day 28
|
12.5 Percentage of patients
Interval 6.2 to 21.8
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84)
Nucleocapsid antibodies: Day 56
|
12.5 Percentage of patients
Interval 6.2 to 21.8
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84)
Nucleocapsid antibodies: Day 84
|
12.5 Percentage of patients
Interval 6.2 to 21.8
|
—
|
SECONDARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients who received a SARS-CoV-2 vaccine prior to the Day 0 (baseline) timepoint and had at least one blood test taken during the study. Patients were included in the analysis at each timepoint if they had available assay results at that timepoint. The analysis was restricted to Arm B patients, as antibody test results were not available for the eligible Arm A patient.
Percentage of participants at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (spike-protein), in patients who received at least one SARS-CoV-2 vaccine prior to Day 0. Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol.
Outcome measures
| Measure |
Arm B
n=63 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Participants at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0
Spike-protein antibodies: Day 0
|
61.9 Percentage of patients
Interval 48.8 to 73.9
|
—
|
|
Percentage of Participants at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0
Spike-protein antibodies: Day 28
|
71.7 Percentage of patients
Interval 57.7 to 83.2
|
—
|
|
Percentage of Participants at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0
Spike-protein antibodies: Day 56
|
81.3 Percentage of patients
Interval 67.4 to 91.1
|
—
|
|
Percentage of Participants at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0
Spike-protein antibodies: Day 84
|
91.5 Percentage of patients
Interval 79.6 to 97.6
|
—
|
SECONDARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients who received a SARS-CoV-2 vaccine prior to the Day 0 (baseline) timepoint and had at least one blood test taken during the study. Patients were included in the analysis at each timepoint if they had available assay results at that timepoint. The analysis was restricted to Arm B patients, as test results on pseudovirus neutralisation were not available for the eligible Arm A patient.
Percentage of participants at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of pseudovirus neutralisation (1/40 titre), in patients who received at least one SARS-CoV-2 vaccine prior to Day 0. A pseudovirus assay was used to assess the prevalence of positive neutralising antibodies (achieving pVNT50 at 1/40 serum dilution).
Outcome measures
| Measure |
Arm B
n=64 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Participants at Each Sample Timepoint With a Positive Detection of Pseudovirus Neutralisation (1/40 Titre), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0
Pseudovirus neutralisation (1/40 titre): Day 0
|
59.4 Percentage of patients
Interval 46.4 to 71.5
|
—
|
|
Percentage of Participants at Each Sample Timepoint With a Positive Detection of Pseudovirus Neutralisation (1/40 Titre), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0
Pseudovirus neutralisation (1/40 titre): Day 28
|
67.9 Percentage of patients
Interval 53.7 to 80.1
|
—
|
|
Percentage of Participants at Each Sample Timepoint With a Positive Detection of Pseudovirus Neutralisation (1/40 Titre), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0
Pseudovirus neutralisation (1/40 titre): Day 56
|
60 Percentage of patients
Interval 45.2 to 73.6
|
—
|
|
Percentage of Participants at Each Sample Timepoint With a Positive Detection of Pseudovirus Neutralisation (1/40 Titre), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0
Pseudovirus neutralisation (1/40 titre): Day 84
|
83 Percentage of patients
Interval 69.2 to 92.4
|
—
|
SECONDARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients who did not receive a SARS-CoV-2 vaccine during the study. Patients were included in the analysis at each timepoint if they had available assay results at that timepoint. The analysis was restricted to Arm B patients, as antibody test results were not available for the eligible Arm A patient.
Percentage of patients at each sample timepoint (Day 0 (baseline), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (spike-protein), in patients who did not receive a SARS-CoV-2 vaccine during the study. Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol.
Outcome measures
| Measure |
Arm B
n=49 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study.
Spike-protein antibodies: Day 0
|
8.2 Percentage of patients
Interval 2.3 to 19.6
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study.
Spike-protein antibodies: Day 28
|
7 Percentage of patients
Interval 1.5 to 19.1
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study.
Spike-protein antibodies: Day 56
|
14.7 Percentage of patients
Interval 5.0 to 31.1
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study.
Spike-protein antibodies: Day 84
|
3.7 Percentage of patients
Interval 0.0 to 19.0
|
—
|
SECONDARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients who did not receive any SARS-CoV-2 vaccine prior to the Day 0 (baseline) timepoint, had at least one blood test taken during the study, and did not receive a SARS-CoV-2 vaccine during the study. Patients were included in the analysis at each timepoint if they had available assay results at that timepoint. The analysis was restricted to Arm B patients, as antibody test results were not available for the eligible Arm A patient.
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (nucleocapsid), in patients who did not receive a COVID-19 vaccine during the study. Nucleocapsid (anti-N) antibodies were analysed with the Elecsys SARS-CoV-2 assay on a Cobas analyser (Roche). As specified by the manufacturer, values above a cut-off index (COI) ≥ 1.0 were reported as positive.
Outcome measures
| Measure |
Arm B
n=51 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study.
Nucleocapsid antibodies: Day 0
|
7.8 Percentage of patients
Interval 2.2 to 18.9
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study.
Nucleocapsid antibodies: Day 28
|
6.8 Percentage of patients
Interval 1.4 to 18.7
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study.
Nucleocapsid antibodies: Day 56
|
11.8 Percentage of patients
Interval 3.3 to 27.5
|
—
|
|
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study.
Nucleocapsid antibodies: Day 84
|
3.7 Percentage of patients
Interval 0.0 to 19.0
|
—
|
SECONDARY outcome
Timeframe: 0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days from the date of the patient's 1st SARS-CoV-2 vaccine dose (relative to each patient)Population: Patients who received a SARS-CoV-2 vaccine prior to the Day 0 (baseline) timepoint and had at least one blood test taken during the study. Patients were analysed if they had available assay results during at least one of the following time periods from the date of their 1st vaccine dose (0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days). The analysis was restricted to Arm B patients, as antibody test results were not available for the eligible Arm A patient.
Percentage of participants with a positive detection of IgG specific antibodies to SARS-CoV-2 (spike-protein), at time periods relative to the date of 1st SARS-CoV-2 vaccine dose. Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol.
Outcome measures
| Measure |
Arm B
n=57 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 0-19 days
|
30 Percentage of patients
Interval 17.9 to 44.6
|
—
|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 20-39 days
|
70.2 Percentage of patients
Interval 56.6 to 81.6
|
—
|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 40-59 days
|
64.4 Percentage of patients
Interval 48.8 to 78.1
|
—
|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 60-79 days
|
79.5 Percentage of patients
Interval 63.5 to 90.7
|
—
|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 80-99 days
|
86.1 Percentage of patients
Interval 72.1 to 94.7
|
—
|
SECONDARY outcome
Timeframe: 0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days from the date of the patient's 1st SARS-CoV-2 vaccine dose (relative to each patient)Population: Patients who received a SARS-CoV-2 vaccine prior to the Day 0 (baseline) timepoint and had at least one blood test taken during the study. Patients were analysed if they had available assay results during at least one of the following time periods from the date of their 1st vaccine dose (0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days). The analysis was restricted to Arm B patients, as pseudovirus neutralisation test results were not available for the eligible Arm A patient.
Percentage of participants with a positive detection of pseudovirus neutralisation (1/40 titre), at time periods relative to the date of 1st SARS-CoV-2 vaccine dose. A pseudovirus assay was used to assess the prevalence of positive neutralising antibodies (achieving pVNT50 at 1/40 serum dilution)
Outcome measures
| Measure |
Arm B
n=57 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 0-19 days
|
40.4 Percentage of patients
Interval 27.0 to 54.9
|
—
|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 20-39 days
|
71.9 Percentage of patients
Interval 58.5 to 83.0
|
—
|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 40-59 days
|
57.8 Percentage of patients
Interval 42.2 to 72.3
|
—
|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 60-79 days
|
65 Percentage of patients
Interval 48.3 to 79.4
|
—
|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 80-99 days
|
68.2 Percentage of patients
Interval 52.4 to 81.4
|
—
|
SECONDARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients who had at least one blood test taken during the study. Patients were included in the analysis at each timepoint if they had available assay results at that timepoint. The analysis was restricted to Arm B patients, as antibody and pseudovirus neutralisation test results were not available for the eligible Arm A patient.
Sensitivity: the percentage of participants with a positive detection of IgG specific antibodies to SARS-CoV-2 (spike protein) out of those who had a positive neutralisation detection at the PV50 threshold from the pseudovirus assay, at each sample timepoint. Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol. A pseudovirus assay was used to assess the prevalence of positive neutralising antibodies (achieving pVNT50 at 1/40 serum dilution).
Outcome measures
| Measure |
Arm B
n=146 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
Day 0
|
88.5 Sensitivity (%)
|
—
|
|
Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
Day 28
|
80.8 Sensitivity (%)
|
—
|
|
Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
Day 56
|
89.8 Sensitivity (%)
|
—
|
|
Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
Day 84
|
96.7 Sensitivity (%)
|
—
|
SECONDARY outcome
Timeframe: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84Population: Patients who had at least one blood test taken during the study. Patients were included in the analysis at each timepoint if they had available assay results at that timepoint. The analysis was restricted to Arm B patients, as antibody and pseudovirus neutralisation test results were not available for the eligible Arm A patient.
Specificity: the percentage of participants with a negative detection of IgG specific antibodies to SARS-CoV-2 (spike protein) out of those who had a negative neutralisation detection at the PV50 threshold from the pseudovirus assay, at each sample timepoint. Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol. A pseudovirus assay was used to assess the prevalence of positive neutralising antibodies (achieving pVNT50 at 1/40 serum dilution)
Outcome measures
| Measure |
Arm B
n=146 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Specificity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
Day 0
|
94.7 Specificity (%)
|
—
|
|
Specificity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
Day 28
|
90.8 Specificity (%)
|
—
|
|
Specificity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
Day 56
|
76.2 Specificity (%)
|
—
|
|
Specificity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
Day 84
|
86.4 Specificity (%)
|
—
|
POST_HOC outcome
Timeframe: 0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days from the date of the patient's 2nd SARS-CoV-2 vaccine dose (relative to each patient)Population: Patients who received a second SARS-CoV-2 vaccine, had a vaccine prior to the Day 0 (baseline) timepoint and had at least one blood test taken during the study. Patients were analysed if they had available assay results during at least one of the following time periods from the date of their 2nd vaccine dose (0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days). The analysis was restricted to Arm B patients, as antibody test results were not available for the eligible Arm A patient.
Percentage of participants with a positive detection of IgG specific antibodies to SARS-CoV-2 (spike-protein), at time periods relative to the date of 2nd vaccine dose (0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days). Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol.
Outcome measures
| Measure |
Arm B
n=38 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 40-59 days
|
95 Percentage of patients
Interval 75.1 to 99.9
|
—
|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 0-19 days
|
84.2 Percentage of patients
Interval 68.7 to 94.0
|
—
|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 20-39 days
|
96 Percentage of patients
Interval 79.6 to 99.9
|
—
|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 60-79 days
|
100 Percentage of patients
Confidence interval bounds were not defined as the percentage of patients with a positive detection was 100%.
|
—
|
|
Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Spike-protein antibodies: 80-99 days
|
100 Percentage of patients
Confidence interval bounds were not defined as the percentage of patients with a positive detection was 100%.
|
—
|
POST_HOC outcome
Timeframe: 0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days from the date of the patient's 2nd SARS-CoV-2 vaccine dose (relative to each patient)Population: Patients who received a second SARS-CoV-2 vaccine, and had a vaccine prior to the Day 0 (baseline) timepoint. Patients were analysed if they had available assay results during at least one of the following time periods from the date of their 2nd vaccine dose (0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days). The analysis was restricted to Arm B patients, as pseudovirus neutralisation test results were not available for the eligible Arm A patient.
Percentage of participants with a positive detection of pseudovirus neutralisation (1/40 titre), at time periods relative to the date of 2nd SARS-CoV-2 vaccine dose (0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days). A pseudovirus assay was used to assess the prevalence of positive neutralising antibodies (achieving pVNT50 at 1/40 serum dilution)
Outcome measures
| Measure |
Arm B
n=39 Participants
Asymptomatic patients with no clinical suspicion of COVID-19.
|
Arm A
Patients with a suspected acute COVID-19 infection.
|
|---|---|---|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 0-19 days
|
76.9 Percentage of patients
Interval 60.7 to 88.9
|
—
|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 20-39 days
|
84 Percentage of patients
Interval 63.9 to 95.5
|
—
|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 40-59 days
|
90 Percentage of patients
Interval 68.3 to 98.8
|
—
|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 60-79 days
|
90 Percentage of patients
Interval 55.5 to 99.7
|
—
|
|
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
Pseudovirus neutralisation (1/40 titre): 80-99 days
|
100 Percentage of patients
Confidence interval bounds were not defined as the percentage of patients with a positive detection was 100%.
|
—
|
Adverse Events
Arm A
Arm B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Trial Manager (for the CARDS study)
The Royal Marsden NHS Foundation Trust
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place