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

Organizational Data

DRKS-ID:
DRKS00026071
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2021-08-23
Last update in DRKS:
2021-08-23
Registration type:
Retrospective

Acronym/abbreviation of the study

COVID DEXA

URL of the study

No Entry

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.

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.

Health condition or problem studied

ICD10:
B44.0 - Invasive pulmonary aspergillosis
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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.

Endpoints

Primary outcome:
Occurence of CAPA
Secondary outcome:
severity of illness

Study Design

Purpose:
Diagnostic
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Anästhesiologie Essen

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2021-05-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
200
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
99 Years
Additional Inclusion Criteria:
COVID-19 Pneumonia Asp-Ag positive or culture pos or PCR pos

Exclusion Criteria

not fullfilled inclusion criteria

Addresses

Primary Sponsor

Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uniklinikum-essen.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Essen. Klinik für Anästhesie und Intensivmedizin
Dr.med. Simon Dubler
Hufelandstrasse 55
45112 Essen
Germany
Telephone:
02017231401
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum Essen, Klinik für Anästhesie und Intensivmedizin
Dr.med. Simon Dubler
Hufelandstrasse 55
45112 Essen
Germany
Telephone:
02017231401
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum Essen. Klinik für Anästhesie und Intensivmedizin
Dr.med. Simon Dubler
Hufelandstrasse 55
45112 Essen
Germany
Telephone:
02017231401
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uniklinikum-essen.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
Robert-Koch-Str. 9-11
45147 Essen
Germany
Telephone:
+49-201-7233637
Fax:
+49-201-7235837
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-04-16
Ethics committee number:
20-9368-BO
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-04-26

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry