Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19
June 22, 2020 updated by: Medical University Innsbruck
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tirol
-
Innsbruck, Tirol, Austria, 6020
- Recruiting
- Medical University Innsbruck
-
Contact:
- Teresa Rauchegger, Dr.
- Phone Number: 0043 504 24184
- Email: teresa.rauchegger@i-med.ac.at
-
Contact:
- Claus Zehetner, Dr.
- Phone Number: 0043 504 24184
- Email: claus.zehetner@i-med.ac.at
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Swab
Conjunctival swab and nasopharyngeal swab for SARS-COV 2
|
Both conjunctival swab and nasopharyngeal swab for SARS-COV 2 are conducted in patients with COVID-19.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SARS-CoV2 positive conjunctival swabs
Time Frame: 1 year
|
The primary endpoint is the number of conjunctival swabs tested positive for SARS-CoV2.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conjunctival swab vs nasopharyngeal swab
Time Frame: 1 year
|
The secondary target is the difference between the conjunctival swab tested positive for SARS-CoV2 and the nasopharyngeal swab.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Viability of SARS-COV 2
Time Frame: 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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 17, 2020
Primary Completion (Anticipated)
March 31, 2021
Study Completion (Anticipated)
March 31, 2021
Study Registration Dates
First Submitted
June 18, 2020
First Submitted That Met QC Criteria
June 22, 2020
First Posted (Actual)
June 23, 2020
Study Record Updates
Last Update Posted (Actual)
June 23, 2020
Last Update Submitted That Met QC Criteria
June 22, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1104/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.