Cancer, Coronavirus Infection, Infectious Disease
Conditions
Keywords
COVID-19, SARS-CoV-2, Cancer, Coronavirus infection
Brief summary
People with cancer may be at higher risk of poor outcomes with COVID-19 infection. This observational study aims to describe the clinical course of COVID-19 infection in people with cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of this study will inform clinical practice in the management of cancer patients with COVID-19.
Detailed description
Patients with cancer are thought to have a weakened immune system and small observational case series have suggested patients with cancer are at a higher risk of poor outcome from COVID-19. However, the clinical course of COVID-19 infection amongst cancer patients is not known. In addition, it is unclear when it is appropriate for cancer patients who have recovered from COVID-19 infection to resume anti-cancer therapy. There is unmet need for diagnostic assays for COVID-19 including tests which can rapidly determine whether the virus has been cleared of the COVID-19. Lateral flow assays investigated in this study are rapid and simple diagnostic tools which can assist in timely diagnostics to inform clinical decision making. This observational study aims to describe the immunological dynamics and clinical course of COVID-19 in cancer patients and evaluate COVID-19 antibody and antigen lateral flow assays. The information from our study will add significantly to the understanding of COVID-19 diagnostics and will improve the evidence-base for the management of cancer patients. Furthermore, data from this study could inform the timing and treatment for cancer patients who have recovered from COVID-19 infection.
Interventions
DIAGNOSTIC_TESTThroat/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.
DIAGNOSTIC_TESTSaliva collection
Saliva will be collected at each study visit, by asking the participant to provide a small amount of saliva (approximately 0.5 millilitres (mL)) will be collected. Saliva will be tested by the lateral flow assay when available and excess material stored.
DIAGNOSTIC_TESTBlood collection
Approximately 30mL of blood will be taken at each study visit.
Sponsors
St George's, University of London
Mologic Ltd
The Royal Marsden Cancer Charity
National Institute for Health Research Biomedical Research Centre
Royal Marsden NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suspected COVID-19 infection undergoing diagnostic testing by SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) * Metastatic or advanced solid organ malignancy, including lymphoma OR Early stage solid organ malignancy having received therapy (radiotherapy, chemotherapy or targeted agents) * Patient is ≥ 18 years of age. * Patient can understand the patient information sheet and is able to provide written informed consent.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein). | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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. |
| Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid). | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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. |
| 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) | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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. |
| 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) | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | 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. |
| Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose | 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) | 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) |
| 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 | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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. |
| Specificity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold. | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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) |
| Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold. | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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). |
| 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 | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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). |
| 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. | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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. |
| 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. | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 | 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. |
Countries
United Kingdom
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Arm B Asymptomatic patients with no clinical suspicion of COVID-19
Blood collection: Approximately 30mL of blood will be taken at each study visit. | 152 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Arm B | Total | Arm A |
|---|---|---|---|
| Age, Continuous | 66 years | 67 years | 67 years |
| Anatomical site of malignancy Colorectal | 80 Participants | 80 Participants | 0 Participants |
| Anatomical site of malignancy Hepato pancreatic biliary | 24 Participants | 24 Participants | 0 Participants |
| Anatomical site of malignancy Oesophagogastric | 38 Participants | 38 Participants | 0 Participants |
| Anatomical site of malignancy Other | 10 Participants | 11 Participants | 1 Participants |
| Race/Ethnicity, Customized African | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants | 10 Participants | 0 Participants |
| Race/Ethnicity, Customized Caribbean | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 128 Participants | 129 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed race | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Oriental | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 6 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 152 participants | 153 participants | 1 participants |
| Sex: Female, Male Female | 60 Participants | 60 Participants | 0 Participants |
| Sex: Female, Male Male | 92 Participants | 93 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid).
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.
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Primary
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)
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.
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Primary
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)
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.
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Primary
Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).
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.
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Secondary
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
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.
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
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 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Secondary
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
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).
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
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 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Secondary
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
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)
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Secondary
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.
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.
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Secondary
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.
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.
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Secondary
Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
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).
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 (%) |
| Arm B | 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 (%) |
| Arm B | 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 (%) |
| Arm B | 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
Specificity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
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)
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 (%) |
| Arm B | 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 (%) |
| Arm B | 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 (%) |
| Arm B | 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
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
Post Hoc
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 2nd SARS-CoV-2 Vaccine Dose
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)
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |
| Arm B | 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 |