Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19
Sponsor
Medical University Innsbruck (Other)
Overall Status
Unknown status
CT.gov ID
NCT04444596
Collaborator
(none)
100
1
1
9.4
10.6
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19
Actual Study Start Date
:
Jun 17, 2020
Anticipated Primary Completion Date
:
Mar 31, 2021
Anticipated Study Completion Date
:
Mar 31, 2021
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Swab Conjunctival swab and nasopharyngeal swab for SARS-COV 2 |
Diagnostic Test: Conjunctival swab and nasopharyngeal swab
Both conjunctival swab and nasopharyngeal swab for SARS-COV 2 are conducted in patients with COVID-19.
|
Outcome Measures
Primary Outcome Measures
- SARS-CoV2 positive conjunctival swabs [1 year]
The primary endpoint is the number of conjunctival swabs tested positive for SARS-CoV2.
Secondary Outcome Measures
- Conjunctival swab vs nasopharyngeal swab [1 year]
The secondary target is the difference between the conjunctival swab tested positive for SARS-CoV2 and the nasopharyngeal swab.
Other Outcome Measures
- Viability of SARS-COV 2 [1 year]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Medical University Innsbruck | Innsbruck | Tirol | Austria | 6020 |
Sponsors and Collaborators
- Medical University Innsbruck
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT04444596
Other Study ID Numbers:
- 1104/2020
First Posted:
Jun 23, 2020
Last Update Posted:
Jun 23, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: