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

Cancer Clinical Trial

— COVIDOUT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779346
• Other study ID #: 2020-10275-BO-ff
• Status: Recruiting
• Start date: December 21, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Marianne Sinn, MD
• Phone: +49407410
• Email: ma.sinn[@]uke.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Coronavirus Infections
• Covid19
• Immunity
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of SARS-CoV-2 antibody positive patients	Measured in percentage	1 year
Primary	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
Primary	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	Rate of unknown prior COVID19 disease in SARS-CoV-2 antibody positive patients	Measured in percentage	1 year
Secondary	Rate of cancer entities in SARS-CoV-2 antibody positive patients	Measured in percentage	1 year
Secondary	Rate of therapy modalities in SARS-CoV-2 antibody positive patients	Measured in percentage	1 year
Secondary	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
Secondary	Rate of re-infection in SARS-CoV-2 antibody positive patients	Measured in percentage	1 year