App-based Symptom Tracking After Corona Vaccination (CoCoV) | NCT04686409

Studies
App-based Symptom Tracking After Corona Vaccination (CoCoV)

NCT04686409

Sponsor

University of Ulm

Status

Unknown status

Last Update Posted

Dec 28, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Adverse Events in COVID-19 Vaccination

Interventions

COVID-19 vaccines

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2021Estimated

Primary Completion Date

Jan 31, 2022Estimated

Completion Date

Aug 31, 2022Estimated

First Submitted Date

Dec 22, 2020

First Submission Date that Met QC Criteria

Dec 22, 2020

First Posted Date

Dec 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2020

Last Update Posted Date

Dec 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID-19 vaccines	Biological	Participants will be vaccinated with one of the approved COVID-19 vaccines

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Distribution and deviation of documented side effects	Descriptive statistics for different side effects	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Adult volunteers (≥ 18 years) who received a COVID-19 vaccination.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Seufferlein, Prof. Dr.	Contact	+4973150044501		thomas.seufferlein@uniklinik-ulm.de

Overall Officials

Name	Affiliation	Role
Thomas Seufferlein, Prof. Dr.	University Hospital Ulm	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Ulm		Ulm			Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000086663	COVID-19 Vaccines

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided