Clinical Trials

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.

COVID-19

NAPKON HAP

Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
NAPKON-HAP

Analysis of pathophysiology and pathology of coronavirus disease 2019 (COVID-19), including chronic morbidity

Status: Active

Purpose / Objectives

Primary Outcome

The aim of NAPKON-HAP is to perform deep longitudinal clinical, molecular and immunological phenotyping in patients with COVID-19 and to assess clinical outcomes and endpoints comprehensively. In particular, the study aims to


(i) elucidate the pathophysiology of the disease
(ii) describe and define clinical outcomes and endpoints
(ii) identify diagnostic and prognostic scores and biomarkers for improved clinical          management
(iii) identify putative therapeutic targets
(iv) provide evidence regarding short- and long-term clinical outcomes
(iv) identify correlates of protective immunity
(v) understand potential risk factors and the role of comorbidities in disease               progression
(vi) provide a basis for the development of therapeutic interventions and      mitigation of disease severity

Secondary Outcomes

  • To investigate effects of SARS-CoV-2 infection on different single organ systems.
  •  To investigate effects of SARS-CoV-2 infection on the innate immune system and activation of the adaptive immune system.
  •  To characterize the SARS-CoV-2 induced immune response over time to identify biomarkers and therapeutic strategies.
  • To describe the SARS-CoV-2 induced adaptive (humoral and cellular) immune response to support the development of vaccines.
  • To describe the role of bacterial and viral co-infection in COVID-19.
  • To analyze the viral diversity and viral load of SARS-CoV-2 during the infection.
  • To perform single cell multi-omics analysis of patient material (blood, BAL, swaps, tissue) to provide insights into SARS-CoV-2 infection and identify therapeutic targets and to perform an integrated analysis of multi-omics with clinical data.
  • To identify epigenetic factors influencing clinical course of COVID-19.

Diagnosis

  • COVID-19 infection

Target population

Age

18-99

Inclusion criteria

  •  Age ≥ 18 years
  • Willingness to participate in the study (consent to participate by patient or appropriate legal representative) or inclusion via deferred consent
  •  Hospitalization at time of enrollment
  •  Positive evidence for SARS-CoV-2 infection with PCR or initial positive rapid diagnostic test in conjunction with typical clinical symptoms, confirmed by a later positive PCR test.

Exclusion criteria

  •  Refusal to participate by patient, or appropriate legal representative
  •  Any condition that prohibits supplemental blood-sampling beyond routine blood drawing

Study design

  • Multicenter
  • Prospective
  • Cohort

Intervention

none

Documents (password protected)

Go to download area

Responsibilities in overall study

(National) Coordinating Investigator

Univ.-Prof. Dr. med. Martin Witzenrath