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).

COVID-19 RNA Bluttest

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS

Blood RNA COVID-19 Evaluation Test

Status: Planned (Transit Ethics), pub.

Purpose / Objectives

Primary Outcome

Direct sequencing of total blood RNA from patients with suspected viral infections can reveal differentially expressed microbial and host genetic signatures or biomarkers.

 

Biomarkers of disease and health can be determined from clinical trials of patient groups that consist of symptomatic and asymptomatic patients with viral infections as compared to apparently healthy controls. Multiple samples from individuals further advance our understanding of the dynamics of viral diseases.

  • The aim of this study is to determine the blood biomarkers associated with patients suspected of a viral disease
  • Correlate blood RNA biomarkers through differential expression with patient immune status
  • Correlate blood RNA biomarkers through differential expression with COVID-19 load 
  • Correlate blood RNA biomarkers through differential expression with other co-infectant loads

Diagnosis

Patient attributes

Inclusion criteria

This study will focus on COVID-19 patient groups as well as symptomatic patients not positive for COVID-19.

Intervention

  • Collection of approximately 20 blood samples per site in PAXgene tubes from COVID-19-positive symptomatic patients.
  • Collection of additional samples from COVID-19-positive asymptomatic patients, COVID-19-negative symptomatic patients, and apparently healthy controls.
  • Serial blood samples from the same patient groups

Documents (password protected)

Responsibilities in overall trial

FBB Biomed, Inc.