Information about participating in the eCOV study  

Dear prospective study participant,

We hereby invite you to participate in the eCOV study. The study is open to individuals 16 years of age and older, that is, vaccinated and unvaccinated adults, and individuals with or without prior coronavirus infection. The study will collect their coronavirus test results, vaccinations, and typical symptoms, if applicable. The study was initiated by the nonprofit organization Data4Life and is scientifically led by PD Dr. med. Cornelius Remschmidt of Data4Life. There is no funding from an external sponsor.

Voluntary participation
Your participation is voluntary. Only if you explicitly agree, your information can be included in the study. If you do not wish to participate, there will be no disadvantage to you personally. You have the right to revoke the consent you have given to participate in the study and to have your data processed. You can stop participating in the study at any time.

eCOV study purpose
The purpose of the eCOV study is to assess, among other measures, the effectiveness of the different coronavirus vaccines outside of clinical trials, that is, in "real-life". All approved vaccines are subject to a rigorous and complex approval process in which not only the efficacy but also the tolerability of the vaccines is extensively investigated in large clinical trials and the entire process is reviewed by officially recognized institutions. These clinical trials (Phase 3 efficacy trials), in the form of randomized controlled trials (RCTs), represent the design with the fewest errors and the most meaningful results. However, despite the large number of study participants, the data collected are not always sufficient to make reliable statements about individual groups of individuals or age groups, as these are not sufficiently represented ("underrepresented") in the clinical studies. It is also unclear at this time how long the protective effects of the various Corona vaccines may last, as these aspects have not been studied in the clinical trials. By participating, you can help the scientific community contribute findings to these unanswered questions. The more participants we can recruit for the study from different age groups and person groups, the more meaningful the study results will be.

Because of the short development time and novelty of the COVID-19 vaccines, there is some uncertainty among the general public as to whether unexpected adverse drug reactions (ADRs) may occur from the new vaccines. Therefore, it is additionally important to report possible ADRs to get a realistic assessment of the side effects of the new vaccines.

Therefore, if you have received a COVID-19 vaccination, you can report possible side effects digitally via the Medikura Digital Health reporting tool as part of this study. Of course, this reporting is also voluntary. The Medikura's website provides a means of recording, forwarding and tracking unexpected adverse drug reactions (ADRs) in accordance with the German Medicines Act (Arzneimittelgesetz).

Procedure and duration of participation
To participate in the eCOV study, you must register in the Data4Life web app and electronically give your consent to participate in the study. You will then be asked to first complete a general questionnaire about your age, chronic pre-existing conditions or previous vaccinations directly in the Data4Life web app. If you do not want to answer individual questions: no problem. You only give the answers you want to give.

In addition, you will be asked to answer a weekly questionnaire about your potential experience with coronavirus disease, symptoms of the disease or the result of a coronavirus test. This is also done in the web app and takes less than 5 minutes. To ensure that you do not forget any of the questionnaires, we will send you reminders by email each time a new questionnaire is available.

To estimate the duration of the effectiveness of the vaccinations over a longer period of time, a longer observation period is necessary. The study is therefore planned for a period of 24 months. The longer you stay involved and support the study, the more meaningful the results of the analyses will be.

Related risks
There are no health risks associated with participation in the eCOV study. Please note that the study does not provide medical recommendations or help in the diagnosis or treatment of COVID-19 and other diseases.

Circumstances that may lead to ending the study participation
You have the right to withdraw the consent you have given to participate in the study or to continue processing your data, and to terminate your participation in the study at any time. The study physician has the right to withdraw study participants from the study for safety reasons or if there are indications of suspected manipulation.

Possible benefits for study participants or for the general public
You cannot expect any personal direct benefit or advantage to your health from the scientific use of your data. Nevertheless, we want to provide you with scientifically proven information about COVID-19 as part of the study, as well as general statistics and evaluations about the study. For the general public, the results of the study will help improve our understanding of the spread of the COVID-19 pandemic and the effectiveness of the COVID-19 vaccine.

Data privacy
Answers from the questionnaires are stored in your Data4Life user account using end-to-end encryption. End-to-end encryption is an encryption method that guarantees that only you can see the answers you provide. Your answers are encrypted directly on your end device (for example, mobile phone, computer), sent to Data4Life, and saved in your user account. You have the possibility to view your end-to-end encrypted answers. For this purpose, your answers are downloaded from your user account to your end device and decrypted on the device. The necessary cryptographic key is stored only locally on your device and is not transmitted to Data4Life. This way, Data4Life can guarantee that only you can link your answers to your user account.

Your data is also stored on the Data4Life Analytics Platform (a platform for conducting study-related data analyses) using pseudonymization. Pseudonymization is a method of altering data, for example, by replacing your name with a unique random number, so that it cannot be linked to you without the use of additional information. Your data is pseudonymized directly on your end device by combining your answers with a pseudonym that is created on your end device. This combination is securely transmitted to the Data4Life Analytics Platform. Additionally, your pseudonym is end-to-end encrypted on your end device and stored in your user account. Only you have the possibility to link the pseudonym to your answers from the study.

Data4Life analyzes the pseudonymized data in the Data4Life Analytics Platform to display to the general public aggregated data about vaccine effectiveness, symptoms, or other recorded measurements as average values. This is done by publicly accessible evaluations (so-called dashboards) which display a data overview as lists, charts, or diagrams.

The data processed in the study by Data4Life is stored exclusively within Germany in certified Data4Life data centers. Data4Life is certified by the German Federal Office for Information Security (BSI) according to ISO 27001 based on IT-Grundschutz.

More info: data privacy

Insurance coverage
Specific insurance coverage for study participants has not been obtained.

Right to ask questions
For questions specifically related to the conduct of the eCOV study, you may contact us at any time using the contact channels listed in our imprint (for example, by e-mail to we@data4life.help). Please note that we are generally not able to answer medical questions (for example, regarding corona infections).

Expenses
In the context of the eCOV study, no expense allowance will be paid to participants. We are therefore all the more pleased about your participation.