NCT04444596

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

June 23, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

June 18, 2020

Last Update Submit

June 22, 2020

Conditions

COVID-19SARS-CoV 2

Outcome Measures

Primary Outcomes (1)

  • SARS-CoV2 positive conjunctival swabs

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

    1 year

Secondary Outcomes (1)

  • Conjunctival swab vs nasopharyngeal swab

    1 year

Other Outcomes (1)

  • Viability of SARS-COV 2

    1 year

Study Arms (1)

Swab

OTHER

Conjunctival swab and nasopharyngeal swab for SARS-COV 2

Diagnostic Test: Conjunctival swab and nasopharyngeal swab

Interventions

Conjunctival swab and nasopharyngeal swabDIAGNOSTIC_TEST

Both conjunctival swab and nasopharyngeal swab for SARS-COV 2 are conducted in patients with COVID-19.

Swab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • A confirmed COVID-19 disease
  • Signed and dated declaration of consent
  • The patient fell ill in Tyrol

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 23, 2020

Study Start

June 17, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

June 23, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)