- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04686409
App-based Symptom Tracking After Corona Vaccination (CoCoV)
December 22, 2020 updated by: Thomas Seufferlein, University of Ulm
The study investigates the side effects of different COVID-19 vaccines.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ulm, Germany
- Universitätsklinikum Ulm
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult volunteers (≥ 18 years) who received a COVID-19 vaccination.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related side effects
Time Frame: 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)
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distribution and deviation of documented side effects
Time Frame: 4 weeks
|
Descriptive statistics for different side effects
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Seufferlein, Prof. Dr., University Hospital Ulm
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 11, 2021
Primary Completion (Anticipated)
January 31, 2022
Study Completion (Anticipated)
August 31, 2022
Study Registration Dates
First Submitted
December 22, 2020
First Submitted That Met QC Criteria
December 22, 2020
First Posted (Actual)
December 28, 2020
Study Record Updates
Last Update Posted (Actual)
December 28, 2020
Last Update Submitted That Met QC Criteria
December 22, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- CoCoV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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