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| ID | Type | Description | Link |
|---|---|---|---|
| 20/NE/0139 | Other Identifier | Research Ethics Committee |
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| Name | Class |
|---|---|
| St George's, University of London | OTHER |
| Mologic Ltd | INDUSTRY |
| The Royal Marsden Cancer Charity | UNKNOWN |
| National Institute for Health Research Biomedical Research Centre |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Suspected acute COVID-19 infection |
| |
| Arm B | Asymptomatic patients with no clinical suspicion of COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Throat/nose swabs | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| 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. | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| 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. | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (greater than or equal to 18 years of age) presenting with suspected COVID-19 infection.
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| Name | Affiliation | Role |
|---|---|---|
| Sheela Rao, MD FRCP | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36342104 | Derived | Lau DK, Aresu M, Planche T, Tran A, Lazaro-Alcausi R, Duncan J, Kidd S, Cromarty S, Begum R, Rana I, Li S, Suwaidan AA, Monahan I, Clark DJ, Eckersley N, Staines HM, Groppelli E, Krishna S, Mayora-Neto M, Temperton N, Fribbens C, Watkins D, Starling N, Chau I, Cunningham D, Rao S. SARS-CoV-2 Vaccine Immunogenicity in Patients with Gastrointestinal Cancer Receiving Systemic Anti-Cancer Therapy. Oncologist. 2023 Jan 18;28(1):e1-e8. doi: 10.1093/oncolo/oyac230. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Arm B | Asymptomatic patients with no clinical suspicion of COVID-19 Blood collection: Approximately 30mL of blood will be taken at each study visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
153 patients were eligible for analysis in the trial: 1 in Arm A and 152 in Arm B.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
|
Data on adverse events were not recorded for the purposes of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Trial Manager (for the CARDS study) | The Royal Marsden NHS Foundation Trust | 020 8642 6011 | 3807 | gi.trials@rmh.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2020 | Oct 17, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2021 | Oct 18, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Arm A | Jul 10, 2020 | Oct 17, 2022 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Arm B | Jul 10, 2020 | Oct 17, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D009369 | Neoplasms |
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| UNKNOWN |
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|
| Saliva collection | Diagnostic Test | 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. |
|
| Blood collection | Diagnostic Test | Approximately 30mL of blood will be taken at each study visit. |
|
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. |
| Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| 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). | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| 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. | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| 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. | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| 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. | 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, 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) | 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) |
| 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). | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| 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) | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
| BG001 | Arm B | Asymptomatic patients with no clinical suspicion of COVID-19 Blood collection: Approximately 30mL of blood will be taken at each study visit. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Anatomical site of malignancy | Count of Participants | Participants |
|
| Arm B |
Asymptomatic patients with no clinical suspicion of COVID-19. |
| OG001 | Arm A | Patients with a suspected acute COVID-19 infection. |
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
|
|
|
| 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | 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) |
|
|
|
| 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) | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | 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) |
|
|
|
| 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). | 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. | Posted | Number | Sensitivity (%) | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
|
|
|
| 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) | 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. | Posted | Number | Specificity (%) | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
|
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | 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) |
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| 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) | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of patients | Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Arm B | Asymptomatic patients with no clinical suspicion of COVID-19 Blood collection: Approximately 30mL of blood will be taken at each study visit. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Nucleocapsid antibodies: Day 28 |
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| Nucleocapsid antibodies: Day 56 |
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| Nucleocapsid antibodies: Day 84 |
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| Spike-protein antibodies: Day 28 |
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| Spike-protein antibodies: Day 56 |
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| Spike-protein antibodies: Day 84 |
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| Pseudovirus neutralisation (1/40 titre): Day 28 |
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| Pseudovirus neutralisation (1/40 titre): Day 56 |
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| Pseudovirus neutralisation (1/40 titre): Day 84 |
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| Spike-protein antibodies: Day 28 |
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| Spike-protein antibodies: Day 56 |
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| Spike-protein antibodies: Day 84 |
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| Nucleocapsid antibodies: Day 28 |
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| Nucleocapsid antibodies: Day 56 |
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| Nucleocapsid antibodies: Day 84 |
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| Spike-protein antibodies: 20-39 days |
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| Spike-protein antibodies: 40-59 days |
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| Spike-protein antibodies: 60-79 days |
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| Spike-protein antibodies: 80-99 days |
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| Pseudovirus neutralisation (1/40 titre): 20-39 days |
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| Pseudovirus neutralisation (1/40 titre): 40-59 days |
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| Pseudovirus neutralisation (1/40 titre): 60-79 days |
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| Pseudovirus neutralisation (1/40 titre): 80-99 days |
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| Day 28 |
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| Day 56 |
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| Day 84 |
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| Day 28 |
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| Day 56 |
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| Day 84 |
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| Spike-protein antibodies: 20-39 days |
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| Spike-protein antibodies: 40-59 days |
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| Spike-protein antibodies: 60-79 days |
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| Spike-protein antibodies: 80-99 days |
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| Pseudovirus neutralisation (1/40 titre): 20-39 days |
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| Pseudovirus neutralisation (1/40 titre): 40-59 days |
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| Pseudovirus neutralisation (1/40 titre): 60-79 days |
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| Pseudovirus neutralisation (1/40 titre): 80-99 days |
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| Spike-protein antibodies: Day 84 |
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| Nucleocapsid antibodies: Day 84 |
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