As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

EIKOS

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
EIKOSDRKS00021468

Exploring immunological control of SARS-CoV-2

Status: Active

Purpose / Objectives

Primary Outcome

Investigation of the immune response against SARS-CoV-2

  • at the time of enrollment, and longitudinally in case of acute infection (at least 5 days between visits)
  • will be determined by ELISA, neutralization assays, cell culture, B cell isolation, and additional assays

 

Secondary Outcomes

Investigation of the risk profile of SARS-CoV-2 infection

  • at the time of enrollment
  • will be determined through a questionnaire and serological analysis

 

Diagnosis

Diagnosed SARS-CoV-2 infection or at risk of infection

 

Patient attributes

Age

18-

Inclusion criteria

General inclusion criteria

  • Age ≥18 years
  • In generally good physical condition (Karnofsky-Index ≥80%)

Additional inclusion criterion when a cumulative blood volume of >100 ml is planned to be drawn:

  • Current or previous laboratory-confirmed SARS-CoV-2 infection

 

Exclusion criteria

Exclusion criteria when a cumulative blood volume of >100 ml is planned to be drawn:

  • Hemoglobin <10 g/dl (in case the blood volume to be drawn over a period of 4 weeks is not above 100 ml, there is no history of blood count abnormalities, and there are no clinical signs of anemia, there is no need for controlling hemoglobin prior to drawing study blood)
  • Symptomatic cardiac disease (e.g., congestive heart failure NYHA ≥II, coronary artery disease)
  • History of myocardial infarction
  • COPD GOLD grade III-IV
  • Body weight <45 kg (for a blood draw of ≥250 mL, a minimum body weight of 50 kg is required)
  • <8 weeks (men) or <12 weeks (women) since last draw of a blood volume of ≥500 ml

 

Trial design

  • Single center
  • Prospective
  • Retrospective
  • Open Label

Documents (password protected)

Responsibilities in overall trial

National Coordinating Investigator

Prof. Dr. Florian Klein