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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Covid19; Immunity

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf
    • Contact: Marianne Sinn, MD; Phone Number: +49407410; Email: ma.sinn@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Outpatient cancer patients; Cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Marianne Sinn, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: 2020-10275-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Aggregated data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No