SARS-CoViD-Endotheliitis Study via Retinal Vascular Analysis (COVID-19)
Organizational Data
- DRKS-ID:
- DRKS00023334
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-10-30
- Last update in DRKS:
- 2023-02-15
- Registration type:
- Retrospective
Acronym/abbreviation of the study
VoViThel
URL of the study
No Entry
Brief summary in lay language
The novel Coronavirus Triggers a disease (CoViD-19) that affects millions of People worldwide. Up until now knowledge is scarce. Especially prognosticytion is difficult. Coronavirus does affect the vascular architecture. In our study we investigate the blood vessels in the eye. We want to show that alterations in dynamic and static Parameters in the vessel can be used to better prognosticate the course of the CoVi-19 disease.
Brief summary in scientific language
We measure the width of ertinal aretioles and venoles as well as the dynmaic changes of These Parameters after Stimulation by flicker-light. We test the association for These parameters with the probability of an intensive care therapy.
Health condition or problem studied
- ICD10:
- U07.1 - COVID-19, virus identified
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Patients with CoViD-19 are teste via dynamic and static retinal vessel analysis, if hospitalisation is ongoing we measure them weekly. After discharge there is a final measurement 6 weeks after discharge together with the post CoViD-19 visit.
Endpoints
- Primary outcome:
- Association of FID art, FID ven, FIC art (Parameters of dynamic vessel Analysis) with the parameter "Intensive Care Therapy"
- Secondary outcome:
- FID art, FID ven and FIC art differ significantly during CoViD-19 in comparison to normal values CRAE, CRVE, CRAE/CRVE Ratio (Parameters of static vessel Analysis) differ significantly during CoViD-19 in comparison to normal values FID art, FID ven and FIC art Change during the course of CoViD-19 Association of the aforementioned Parameters with Ventilation The predictive value of FID art, FID ven, FIC art are better than CrP
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Jena
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2020-09-14
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2021-12-31
- Target Sample Size:
- 30
- Final Sample Size:
- 90
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- CoViD-19
Exclusion Criteria
photosensitive epilepsie, elevated intraocular pressure, pregnancy
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum JenaDr. med Daniel VilserAm Klinikum 107747 JenaGermany
- Telephone:
- 036419329540
- Fax:
- 036419329542
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinikum-jena.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum JenaDr.med. Richard BiedermannAm Klinikum 107747 JenaGermany
- Telephone:
- 036419329631
- Fax:
- 036419328222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinikum-jena.de
Contact for Public Queries
- Address:
- Uniklinikum JenaDr.med. Richard BiedermannAm Klinikum 107747 JenaGermany
- Telephone:
- 036419329631
- Fax:
- 036419328222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinikum-jena.de
Principal Investigator
- Address:
- Universitätsklinikum JenaDr.med. Richard BiedermannAm Klinikum 107747 JenaGermany
- Telephone:
- 036419329631
- Fax:
- 036419328222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinikum-jena.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Kinder- und JugendmedizinAm Klinikum 107747 JenaGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Friedrich-Schiller-Universität Jena an der Medizinischen FakultätBachstr. 18 Gebäude 107740 JenaGermany
- Telephone:
- +49-3641-9391191
- Fax:
- +49-3641-9391192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-05-28
- Ethics committee number:
- 2020-1805BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-07-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- informed consent at the Moment does not include data-sharing.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- 01.01.2024
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry