Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

App-based Symptom Tracking After Corona Vaccination (CoCoV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04686409
Recruitment Status : Not yet recruiting
First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Seufferlein, University Hospital Ulm

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study investigates the side effects of different COVID-19 vaccines.

Condition or disease Intervention/treatment
Adverse Events in COVID-19 Vaccination Biological: 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: App-based Symptom Tracking After Corona Vaccination (CoCoV)
Estimated Study Start Date : January 11, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Distribution and deviation of documented side effects [ Time Frame: 4 weeks ]
    Descriptive statistics for different side effects


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult volunteers (≥ 18 years) who received a COVID-19 vaccination.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686409


Contacts
Layout table for location contacts
Contact: Thomas Seufferlein, Prof. Dr. +4973150044501 thomas.seufferlein@uniklinik-ulm.de

Locations
Layout table for location information
Germany
Universitätsklinikum Ulm
Ulm, Germany
Sponsors and Collaborators
University of Ulm
Investigators
Layout table for investigator information
Principal Investigator: Thomas Seufferlein, Prof. Dr. University Hospital Ulm
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Thomas Seufferlein, Professor, Head of Department, University Hospital Ulm
ClinicalTrials.gov Identifier: NCT04686409    
Other Study ID Numbers: CoCoV
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No