Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19
Primary Purpose
COVID-19, SARS-CoV 2
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Conjunctival swab and nasopharyngeal swab
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- A confirmed COVID-19 disease
- Signed and dated declaration of consent
- The patient fell ill in Tyrol
Exclusion Criteria:
- none
Sites / Locations
- Medical University InnsbruckRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Swab
Arm Description
Conjunctival swab and nasopharyngeal swab for SARS-COV 2
Outcomes
Primary Outcome Measures
SARS-CoV2 positive conjunctival swabs
The primary endpoint is the number of conjunctival swabs tested positive for SARS-CoV2.
Secondary Outcome Measures
Conjunctival swab vs nasopharyngeal swab
The secondary target is the difference between the conjunctival swab tested positive for SARS-CoV2 and the nasopharyngeal swab.
Full Information
NCT ID
NCT04444596
First Posted
June 18, 2020
Last Updated
June 22, 2020
Sponsor
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT04444596
Brief Title
Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19
Official Title
Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this possible study is to identify if SARS-CoV-2 can be found in the tear film and conjunctiva of a patient with COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV 2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Swab
Arm Type
Other
Arm Description
Conjunctival swab and nasopharyngeal swab for SARS-COV 2
Intervention Type
Diagnostic Test
Intervention Name(s)
Conjunctival swab and nasopharyngeal swab
Intervention Description
Both conjunctival swab and nasopharyngeal swab for SARS-COV 2 are conducted in patients with COVID-19.
Primary Outcome Measure Information:
Title
SARS-CoV2 positive conjunctival swabs
Description
The primary endpoint is the number of conjunctival swabs tested positive for SARS-CoV2.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Conjunctival swab vs nasopharyngeal swab
Description
The secondary target is the difference between the conjunctival swab tested positive for SARS-CoV2 and the nasopharyngeal swab.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Viability of SARS-COV 2
Description
In the case of a SARS-COV 2 positive conjunctival swab a virus culture will be conducted to clarify, whether it is a viable virus or virus RNA fragments.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
A confirmed COVID-19 disease
Signed and dated declaration of consent
The patient fell ill in Tyrol
Exclusion Criteria:
none
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Rauchegger, Dr.
Phone
0043 504 24184
Email
teresa.rauchegger@i-med.ac.at
First Name & Middle Initial & Last Name & Degree
Claus Zehetner, Dr.
Phone
0043 504 24184
Email
claus.zehetner@i-med.ac.at
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19
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