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 WA42380

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
WA423802020-001154-22NCT04320615

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

The primary efficacy objective for this study is to evaluate the efficacy of TCZ compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia on the basis of the following endpoint:

  • Clinical status assessed using a 7-category ordinal scale at Day 28

 

Secondary Outcomes

The secondary efficacy objective for this study is to evaluate the efficacy of TCZ
compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia on the basis of the following endpoints:

  • Time to clinical improvement (TTCI) defined as a National Early Warning Score 2 (NEWS2) of  2 maintained for 24 hours
  •  Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
  • Incidence of mechanical ventilation

 

Diagnosis

PATIENTS WITH SEVERE COVID-19 PNEUMONIA

Patient attributes

Age

18-99

Inclusion criteria

  • Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a
    positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily
    fluid) and evidenced by chest X-ray or CT scan
  • SpO2  <93% or PaO2/FiO2 <300 mmHg
  • [...]

 

Exclusion criteria

  • Known severe allergic reactions to TCZ or other monoclonal antibodies
  • Active TB infection
  • Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
  • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
  • Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 6 months

 

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Two-arm
  • Double-blind

Intervention

The investigational medicinal products (IMP) for this study are tocilizumab IV and its matching placebo as the comparator.

Documents (password protected)

Responsibilities in overall trial

F. Hoffmann-La Roche AG

    National Coordinating Investigator

    PD Dr. med. Boris Böll