Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00023334

Trial Description

start of 1:1-Block title

Title

SARS-CoViD-Endotheliitis Study via Retinal Vascular Analysis (COVID-19)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

VoViThel

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

informed consent at the Moment does not include data-sharing.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00023334
  •   2020/10/30
  •   [---]*
  •   yes
  •   Approved
  •   2020-1805BO, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   U07.1 COVID-19
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Association of FID art, FID ven, FIC art (Parameters of dynamic vessel Analysis) with the parameter "Intensive Care Therapy"

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/09/14
  •   30
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

CoViD-19

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

photosensitive epilepsie, elevated intraocular pressure, pregnancy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Jena
    • Mr.  Dr. med  Daniel  Vilser 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Jena
    • Mr.  Dr.med.  Richard  Biedermann 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Uniklinikum Jena
    • Mr.  Dr.med.  Richard  Biedermann 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Kinder- und Jugendmedizin
    • Am Klinikum 1
    • 07747  Jena
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.