App-based Symptom Tracking After Corona Vaccination (CoCoV)

University of Ulm500 enrolled

Overview

The study investigates the side effects of different COVID-19 vaccines.

In this observational study side effects of COVID-19 vaccines will be documented using an open-source mobile application. Participants are invited to answer a questionnaire on a daily basis. Common and unknown events are queried and collected. The primary result of this study will be a descriptive analysis of the collected data.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Adverse Events in COVID-19 Vaccination

Interventions

COVID-19 vaccinesBIOLOGICAL

Participants will be vaccinated with one of the approved COVID-19 vaccines

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * received COVID-19 vaccination * age ≥ 18 years * mobile device (iOS or Android) Exclusion Criteria: * No knowledge of German or English language * No written informed consent

Locations (1)

Universitätsklinikum Ulm

Ulm, Germany

Outcomes

Primary Outcomes

Number of participants with treatment-related side effects

Number of participants with treatment-related side effects as assessed by the toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (status September 2007)

Time frame: 4 weeks

Secondary Outcomes

Distribution and deviation of documented side effects

Descriptive statistics for different side effects

Time frame: 4 weeks

Central Contacts

Thomas Seufferlein, Prof. Dr.

CONTACT

+4973150044501 thomas.seufferlein@uniklinik-ulm.de

Data from ClinicalTrials.gov

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