App-based Symptom Tracking After Corona Vaccination (CoCoV)

• Conditions: Adverse Events in COVID-19 Vaccination

• Registration Number: NCT04686409
• Lead Sponsor: University of Ulm

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Last Update Submitted: 2020-12-22
• Study First Posted: 2020-12-28
• Last Update Posted: 2020-12-28
• Study Start: 2021-01-11
• Primary Completion: 2022-01-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related side effects	4 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Distribution and deviation of documented side effects	4 weeks	Descriptive statistics for different side effects

Trial Locations

Locations (1)

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany