Evaluation of the possibility to gain specimen for SARS-CoV-2 PCR from Aerosol/droplets with a sugar matrix that is applied to a face mask
Organizational Data
- DRKS-ID:
- DRKS00023033
- Recruitment Status:
- Recruiting stopped (after recruiting started)
- Date of registration in DRKS:
- 2020-09-14
- Last update in DRKS:
- 2023-05-16
- Registration type:
- Retrospective
Acronym/abbreviation of the study
Face mask based SARS-CoV-2 specimen obtainment
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
The study will evaluate the feasibility to obtain specimen for a SARS-CoV-2 PCR with a modified surgical face mask. Therefore, in patients with known SARS-Cov-2 infection and planned pharyngeal swab for follow-up PCR a second specimen will be obtained using a face mask that is a equipped with a sugar matrix to bind Aerosol/droplets. The patient is asked to wear the face mask for about 5 minutes while speaking and coughing. SARS-CoV-2 PCR will be performed from both specimen and the results compared
Health condition or problem studied
- ICD10:
- U07.1 - COVID-19, virus identified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Pharyngeal swabs
- Arm 2:
- Face mask based specimen obtainment
Endpoints
- Primary outcome:
- SARS-CoV-2 PCR results of pharyngeal swabs and FFP based specimen
- Secondary outcome:
- acceptance of procedures
Study Design
- Purpose:
- Diagnostic
- Allocation:
- Non-randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting stopped (after recruiting started)
- Reason if recruiting stopped or withdrawn:
- no SARS-CoV-2-detection in mask-derived specimen
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Jena
Recruitment period and number of participants
- Planned study start date:
- 2020-09-01
- Actual study start date:
- 2020-09-09
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 10
- Final Sample Size:
- 3
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- spontaneous breathing patients with known SARS-CoV-2 infectionwith consecutive PCR testing by a pharyngeal swab
Exclusion Criteria
Age< 18, patients with invasive ventilation, patients not able to give informed consent
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum JenaBachstraße 1807740 JenaGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinikum-jena.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Jena - Klinik für Anästhesiologie und Intensivtherapieapl. Prof. Dr. Andreas KortgenAm Klinikum 107747 JenaGermany
- Telephone:
- 036419323101
- Fax:
- 036419323102
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kai.uniklinikum-jena.de
Contact for Public Queries
- Address:
- Universitätsklinikum Jena - Klinik für Anästhesiologie und Intensivtherapieapl. Prof. Dr. Andreas KortgenAm Klinikum 107747 JenaGermany
- Telephone:
- 036419323101
- Fax:
- 036419323102
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kai.uniklinikum-jena.de
Principal Investigator
- Address:
- Universitätsklinikum Jena - Klinik für Anästhesiologie und Intensivtherapieapl. Prof. Dr. Andreas KortgenAm Klinikum 107747 JenaGermany
- Telephone:
- 036419323101
- Fax:
- 036419323102
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kai.uniklinikum-jena.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum JenaBachstraße 1807740 JenaGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinikum-jena.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Friedrich-Schiller-Universität Jena an der Medizinischen FakultätBachstr. 18 Gebäude 107740 JenaGermany
- Telephone:
- +49-3641-9391191
- Fax:
- +49-3641-9391192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-08-07
- Ethics committee number:
- 2020-1877-BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-08-28
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT 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:
- Keine Publikation geplant
- 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