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

• Conditions: Cancer; Immunity; Covid19

• Registration Number: NCT04779346
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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)

Study Timeline

• Study Start: 2020-12-21
• Study First Submitted: 2021-02-27
• Study First Submitted QC: 2021-02-27
• Status Verified: 2021-03
• Study First Posted: 2021-03-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-22
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 vaccinated patients	Up to 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 Outcome Measures

Name	Time	Method
Rate of therapy modalities in SARS-CoV-2 antibody positive patients	1 year	Measured in percentage
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 cancer entities 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

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany