Infectious DiseaseCARDSNCT04427280

Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)

An observational study of Infectious Disease and Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Infectious Disease, Cancer, Coronavirus Infection
What is being tested?: Throat/nose swabs, Saliva collection and Blood collection
How many people: 153 participants
Where: 1 siteUnited Kingdom
Study dates: 26 May 2020to 29 Jun 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients (greater than or equal to 18 years of age) presenting with suspected COVID-19 infection.

Who may be able to join

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.

Who cannot join

There are no exclusion criteria for this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The Royal Marden NHS Foundation Trust
Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Read the 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.

Conditions: Infectious Disease, Cancer, Coronavirus Infection
Being tested: Throat/nose swabs, Saliva collection, Blood collection
Keywords: COVID-19, SARS-CoV-2, Cancer, Coronavirus infection
Medical subject headings: Communicable Diseases, Neoplasms, Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Throat/nose swabsDiagnostic 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.
Saliva collectionDiagnostic 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 collectionDiagnostic test
Approximately 30mL of blood will be taken at each study visit.

Study groups in NCT04427280
Study group	Role	What they receive
Arm A		Suspected acute COVID-19 infection Receives: Diagnostic Test: Throat/nose swabs; Diagnostic Test: Saliva collection; Diagnostic Test: Blood collection
Arm B		Asymptomatic patients with no clinical suspicion of COVID-19 Receives: Diagnostic Test: Blood collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84

Secondary outcomes (8)

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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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)
Measured: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 202029 Jun 2021

First posted11 Jun 2020
Study start26 May 2020
Primary completion29 Jun 2021
Study completion29 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infectious DiseaseStudies of the same condition, open and under way.
More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04427280
Sponsor's protocol ID: CCR 5287
Other IDs: 20/NE/0139
Acronym: CARDS
Status last verified: Aug 2025
First submitted: 21 May 2020
Last updated: 4 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 36342104

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
ClinicalTrials.gov ID: NCT04427280
Acronym / sponsor ID: CARDS / CCR 5287
Conditions: Infectious Disease, Cancer, Coronavirus Infection
Keywords: COVID-19, SARS-CoV-2, Cancer, Coronavirus infection
Study type: Observational
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Royal Marsden NHS Foundation TrustUniversity, hospital or other
Collaborators: St George's, University of London, Mologic Ltd, The Royal Marsden Cancer Charity, Nottingham Biomedical Research Centre
Study start: 26 May 2020 (actual)
Primary completion: 29 Jun 2021 (actual)
Study completion: 29 Jun 2021 (actual)
First posted: 11 Jun 2020 (actual)
Results: Posted 4 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Arm A	–	Diagnostic Test: Throat/nose swabs, Diagnostic Test: Saliva collection, Diagnostic Test: Blood collectionSuspected acute COVID-19 infection
Arm B	–	Diagnostic Test: Blood collectionAsymptomatic patients with no clinical suspicion of COVID-19

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients (greater than or equal to 18 years of age) presenting with suspected COVID-19 infection.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

There are no exclusion criteria for this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Throat/nose swabsThroat/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 test	Arm A
Saliva collectionSaliva 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 test	Arm A
Blood collectionApproximately 30mL of blood will be taken at each study visit.	Diagnostic test	Arm A, Arm B

Primary outcome

Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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.

8 secondary outcomes

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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
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)
Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose
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)
Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.
Time frame: 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.
Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84

Results and safety

Results posted to the registry on 4 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A	1	1
Arm B	152	150

Primary outcome: Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).

Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84. Number (95% Confidence Interval). Unit: Percentage of patients

Measure	Arm B n = 146	Arm A n = 0
Spike-protein antibodies: Day 0	34.9 (27.2 to 43.3)	–
Spike-protein antibodies: Day 28	38.3 (29.8 to 47.3)	–
Spike-protein antibodies: Day 56	52.7 (43 to 62.2)	–
Spike-protein antibodies: Day 84	61.9 (51.9 to 71.2)	–

Population analysed: 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.

Primary outcome: Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid).

Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84. Number (95% Confidence Interval). Unit: Percentage of patients

Measure	Arm B n = 150	Arm A n = 0
Nucleocapsid antibodies: Day 0	14.7 (9.4 to 21.4)	–
Nucleocapsid antibodies: Day 28	14.0 (8.5 to 21.2)	–
Nucleocapsid antibodies: Day 56	16.1 (9.8 to 24.2)	–
Nucleocapsid antibodies: Day 84	14.3 (8.2 to 22.5)	–

Primary outcome: 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)

Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84. Number (95% Confidence Interval). Unit: Percentage of patients

Measure	Arm B n = 78	Arm A n = 0
Spike-protein antibodies: Day 0	34.6 (24.2 to 46.2)	–
Spike-protein antibodies: Day 28	41 (30 to 52.7)	–
Spike-protein antibodies: Day 56	50 (38.5 to 61.5)	–
Spike-protein antibodies: Day 84	60.3 (48.5 to 71.2)	–

Population analysed: 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.

Primary outcome: 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)

Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84. Number (95% Confidence Interval). Unit: Percentage of patients

Measure	Arm B n = 80	Arm A n = 0
Nucleocapsid antibodies: Day 0	12.5 (6.2 to 21.8)	–
Nucleocapsid antibodies: Day 28	12.5 (6.2 to 21.8)	–
Nucleocapsid antibodies: Day 56	12.5 (6.2 to 21.8)	–
Nucleocapsid antibodies: Day 84	12.5 (6.2 to 21.8)	–

Population analysed: 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.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data on adverse events were not recorded for the purposes of this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A	0 of 0	0 of 0	0
Arm B	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36342104Lau 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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Acute Respiratory Infection
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sheela Rao, MD FRCP principal investigator

Royal Marsden NHS Foundation Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Infectious Disease and Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein). (time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04427280, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.