NCT04402853

Brief Summary

Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19 patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant systemic clinical conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

29 days

First QC Date

May 22, 2020

Last Update Submit

December 1, 2020

Conditions

Sars-CoV2Tear

Keywords

COVID 19EYETears

Outcome Measures

Primary Outcomes (1)

  • Virus presence in COVID 19 patients tears

    prevalence of SARS CoV 2 virus on tears

    1 day

Secondary Outcomes (1)

  • Concordance to Naso-Pharingeal Swab

    1 day

Study Arms (1)

COVID 19 Patients

hospitalized patients with COVID 19

Diagnostic Test: Tears swab

Interventions

Tears swabDIAGNOSTIC_TEST

rtPCR on tears swabs samples

COVID 19 Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients with a confirmed diagnosis of COVID 19 pneumonia

You may qualify if:

  • Hospitalized COVID 19 patients

You may not qualify if:

  • Patients with respiratory support that interferes with tears sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Sette Laghi

Varese, 21100, Italy

Location

Related Publications (2)

  • Wu P, Duan F, Luo C, Liu Q, Qu X, Liang L, Wu K. Characteristics of Ocular Findings of Patients With Coronavirus Disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020 May 1;138(5):575-578. doi: 10.1001/jamaophthalmol.2020.1291.

    PMID: 32232433BACKGROUND

  • Hong N, Yu W, Xia J, Shen Y, Yap M, Han W. Evaluation of ocular symptoms and tropism of SARS-CoV-2 in patients confirmed with COVID-19. Acta Ophthalmol. 2020 Aug;98(5):e649-e655. doi: 10.1111/aos.14445. Epub 2020 Apr 26.

    PMID: 32336042RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tears

MeSH Terms

Conditions

LacerationsCOVID-19

Condition Hierarchy (Ancestors)

Wounds and InjuriesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Simone Donati, Professor

    University of Insubria, Varese

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 27, 2020

Study Start

February 1, 2020

Primary Completion

March 1, 2020

Study Completion

May 20, 2020

Last Updated

December 3, 2020

Record last verified: 2020-12

Locations

IT(1)