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).

APN01-COVID-19

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
APN01-01-COVID192020-01172-15NCT04335136

Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19

Status: Active

Purpose / Objectives

Primary Outcome

Cause of death or invasive mechanical ventilation (time frame: 28 days)

The primary endpoint is a composite endpoint of all cause-death or invasive mechanical ventilation up to 28 days or hospital discharge

 

Secondary Outcomes

1. LDH level (time frame: day 5)

Log transformed levels of Lactate dehydrogenase (LDH) at day 5 as a   surrogate marker for organ damage (powered secondary endpoint)

2. Mortality (time frame: 28 days)

28-day mortality (all-cause-death)

3. VFD (time frame: 28 days)

Ventilator-free days (VFD) up to 28 days or hospital discharge

4. Time to death (time frame: 28 days)

Time to death (all causes)

Diagnosis

Patient attributes

Age

35-80

Inclusion criteria

  1. Hospitalized male or female
  2. Diagnosed to be COVID-19 POSITIV
  3. Signed Inform Consent Form

 

Exclusion criteria

  1. Any patient whose clinical condition is deteriorating rapidly
  2. Known positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody
  3. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
  4. Pregnant females as determined by positive serum or urine hCG test prior to dosing
  5. Lung transplantation
  6. Pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis or peritoneal dialysis
  7. There are other uncontrolled co-morbidities that increase the risks associated with the study drug administration, that are assessed by the medical expert team as unsuitable
  8. Patient in trials for COVID-19 within 30 days before ICF
  9. Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants)

 

Trial design

  • Phase II
  • Multicenter
  • Randomized
  • Parallel
  • Double-blind
  • Placebo-controlled

Intervention

Patients will be treated with APN01 or Placebo intravenously twice daily (BID).

 

Documents (password protected)

Responsibilities in overall trial

Apeiron Biologics AG

National Coordinating Investigator

Prof. Dr. med. Henning Bundgaard