Adverse Events in COVID-19 VaccinationNCT04686409
App-based Symptom Tracking After Corona Vaccination (CoCoV)
An observational study of Adverse Events in COVID-19 Vaccination, run by University of Ulm at 1 site in Germany.
Trial summary
The study investigates the side effects of different COVID-19 vaccines. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Events in COVID-19 Vaccination
- What is being tested?
- COVID-19 vaccines
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jan 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult volunteers (≥ 18 years) who received a COVID-19 vaccination.
Who may be able to join
- received COVID-19 vaccination
- age ≥ 18 years
- mobile device (iOS or Android)
Who cannot join
- No knowledge of German or English language
- No written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The study investigates the side effects of different COVID-19 vaccines.
Read the 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.
- Conditions
- Adverse Events in COVID-19 Vaccination
- Being tested
- COVID-19 vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccinesBiological
Participants will be vaccinated with one of the approved COVID-19 vaccines
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (1)
Distribution and deviation of documented side effects
Descriptive statistics for different side effects
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start11 Jan 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Events in COVID-19 VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Seufferlein, University Hospital Ulm
- Investigators
- Thomas Seufferlein, Prof. Dr., Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686409
- Sponsor's protocol ID
- CoCoV
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-based Symptom Tracking After Corona Vaccination (CoCoV)
- ClinicalTrials.gov ID
- NCT04686409
- Acronym / sponsor ID
- CoCoV
- Conditions
- Adverse Events in COVID-19 Vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 11 Jan 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult volunteers (≥ 18 years) who received a COVID-19 vaccination.
Key inclusion criteria (3 listed)
- received COVID-19 vaccination
- age ≥ 18 years
- mobile device (iOS or Android)
Key exclusion criteria (2 listed)
- No knowledge of German or English language
- No written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccinesParticipants will be vaccinated with one of the approved COVID-19 vaccines | Biological | – |
Primary outcome
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)
1 secondary outcome
Distribution and deviation of documented side effects
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Individual participant dataSharing planned: Undecided
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COVID-19 Reactogenicity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Seufferlein, Prof. Dr. principal investigator
University Hospital Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Events in COVID-19 Vaccination, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Seufferlein, Prof. Dr. (+4973150044501, thomas.seufferlein@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related side effects (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.