App-based Symptom Tracking After Corona Vaccination (CoCoV)

Adverse Events in COVID-19 Vaccination Clinical Trial

Official title:

App-based Symptom Tracking After Corona Vaccination (CoCoV)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04686409
• Other study ID #: CoCoV
• Status: Not yet recruiting
• Start date: January 11, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2020
• Source: University of Ulm
• Contact: Thomas Seufferlein, Prof. Dr.
• Phone: +4973150044501
• Email: thomas.seufferlein[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Events in COVID-19 Vaccination

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	4 weeks
Secondary	Distribution and deviation of documented side effects	Descriptive statistics for different side effects	4 weeks