Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting

Study Overview
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Brief Summary
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The COVIDOUT study will prospectively investigate the serological immunity of outpatient cancer patients to evaluate the prevalence of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and dependency of serological immunity on systemic (chemo)therapy after COVID19 disease as well as after vaccination.

Detailed Description
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In this prospective observational study all cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE) will be included in the study upon consent. Data will be collected as follows: (i) Serological antibody screening at study inclusion and every 3 months (ia) In case of vaccination monthly screening for 3 months (ii) Routine clinical data: demographic and biometric data, medical history, common laboratory parameters (iii) Patient questionnaire: assessment of past COVID-19 infection, past COVID-19 specific symptoms, social environment, vaccination Recruitment is limited to a one-year period (December 2020 - December 2021)

Official Title
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Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting: Prevalence and Serological Immunity in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf

Conditions
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Cancer, Covid19, Immunity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known diagnosis of cancer Active disease or (in case of cure) last systemic therapy <12 months Signed informed consent Exclusion Criteria: Refusal of participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatient cancer patients<br>Cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of SARS-CoV-2 antibody positive patients | Measured in percentage | 1 year | 
| Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 antibody positive patients | Measured in percentage | Up to 1 year | 
| Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients | Measured in percentage | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of unknown prior COVID19 disease in SARS-CoV-2 antibody positive patients | Measured in percentage | 1 year | 
| Rate of cancer entities in SARS-CoV-2 antibody positive patients | Measured in percentage | 1 year | 
| Rate of therapy modalities in SARS-CoV-2 antibody positive patients | Measured in percentage | 1 year | 
| Subgroup analysis of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients | Dependency of rate on cancer entity, therapy modality, age, sex and immune status [Measured in percentage] | Up to 1 year | 
| Rate of re-infection in SARS-CoV-2 antibody positive patients | Measured in percentage | 1 year |