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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04779346

Acronym

COVIDOUT

Enrollment

500

Registered

2021-03-03

Start date

2020-12-21

Completion date

2022-12-31

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Covid19, Immunity

Brief summary

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

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Primary ContactMarianne Sinn, MD

ma.sinn@uke.de+49407410

Backup ContactMartin Schönlein, MD

m.schoenlein@uke.de+49407410

Outcome results