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
  • Diagnostic Test: Conjunctival swab and nasopharyngeal swab
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

  1. SARS-CoV2 positive conjunctival swabs [1 year]

    The primary endpoint is the number of conjunctival swabs tested positive for SARS-CoV2.

Secondary Outcome Measures

  1. 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

  1. 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:

Study Results

No Results Posted as of Jun 23, 2020