Trial document





This trial has been registered retrospectively.
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  DRKS00026071

Trial Description

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Title

Incidence of SARS-CoV-2 (COVID-19) -associated pulmonary aspergillosis (CAPA) before and after dexamethasone therapy - a retrospective analysis

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Trial Acronym

COVID DEXA

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URL of the Trial

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Brief Summary in Lay Language

With this project we would like to try to clarify how often and why CAPA occurs in the event of a severe COVID19 illness.

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Brief Summary in Scientific Language

A. fumigatus is a ubiquitous fungus of the genus of the watering can mold that occurs in the environment. In the dormant form, A. fumigatus is present as a conidia. If the spores germinate, pathogenic hyphae develop after differentiation. Humans inhale thousands of conidia every day without causing an infection. However, if the immune system is weakened, A. fumigatus can cause a life-threatening infection in humans, e.g. in the form of invasive pulmonary aspergillosis (IPA). Especially patients after transplantation of solid organs (e.g. lungs) or stem cells, with sepsis / septic shock or with influenza infections are particularly at risk of developing an IPA. It should be emphasized that IPA is associated with a mortality of> 60% in these patient groups.
In the course of the prevailing SARS-CoV-2 pandemic, it has been shown that even patients with severe courses of COVID19 disease are at risk of developing an IPA (so-called "COVID-Associated Pulmonary Aspergillosis", CAPA for short), although large prevalence surveys and the exact pathophysiology is currently insufficiently researched. There is also scientific evidence from individual case studies that the introduction of dexamethasone therapy in severe COVID19 disease has led to a more frequent occurrence of CAPA.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00026071
  •   2021/08/23
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  •   yes
  •   Approved
  •   20-9368-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   B44.0 -  Invasive pulmonary aspergillosis
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Interventions/Observational Groups

  •   Retrospective data analysis of all patients who had to be treated in the anesthesiological intensive care unit of essen university hospital between March 2020 and February 2021 due to COVID-19 pneumonia. The study compared patients who received dexamethasone versus patients who did not receive dexamethasone. In addition to previous illnesses, data on the occurrence of fungal, viral and bacterial co-infections, their therapy, ventilation hours and the time in the intensive care unit are collected.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Occurence of CAPA

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Secondary Outcome

severity of illness

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/05/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

COVID-19
Pneumonia
Asp-Ag positive
or
culture pos
or
PCR pos

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Exclusion Criteria

not fullfilled inclusion criteria

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen. Klinik für Anästhesie und Intensivmedizin
    • Mr.  Dr.med.  Simon  Dubler 
    • Hufelandstrasse 55
    • 45112  Essen
    • Germany
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    • Universitätsklinikum Essen, Klinik für Anästhesie und Intensivmedizin
    • Mr.  Dr.med.  Simon  Dubler 
    • Hufelandstrasse 55
    • 45112  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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