NCT04364594

Brief Summary

The patients enrolled in this study will be all patients entering triage with suspicion of SARS-CoV2. Planned activities are required by the nasopharyngeal swab in parallel with the analysis of the conjunctival swab to identify new potential alternative and equally effective diagnostic pathways. Simultaneously systemic data (as Pulmonary images, hematological parameters etc.) will be collected to observe a possible correlation between conjunctival swab positivity and systemic impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

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

March 26, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

29 days

First QC Date

April 22, 2020

Last Update Submit

July 22, 2020

Conditions

COVID 19Pulmonary Disease

Keywords

Conjunctival swabsDiagnosisSARS-CoV2Systemic Impairment

Outcome Measures

Primary Outcomes (1)

  • Conjunctival swab results based on RT-PCR

    Collection of conjunctival cell samples from eyes of COVID-19 patients. Analysis of conjunctival cells by real-time PCR to document presence of COVID-19. Binary outcome: yes, no. To evaluate the result in relation to nasopharyngeal swab (binary outcome yes, no) and to correlate conjunctival with nasopharyngeal swab positivity

    2 months

Secondary Outcomes (1)

  • Conjunctival swab positivity in relation to Pulmonary and blood abnormalities

    2 months

Study Arms (1)

affected individual

EXPERIMENTAL

Patients affected by Coronavirus 19 admitted to the hospital setting

Diagnostic Test: conjunctival swab

Interventions

conjunctival swabDIAGNOSTIC_TEST

analysis of conjunctival cells (real time PCR) collected by conjunctival swabs in both eyes

Also known as: Pulmonary involvement determined by X-Ray (XR) rays and Computed Tomography (CT) scan
affected individual

Eligibility Criteria

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

You may qualify if:

  • All patients accepted to triage with positivity or suspected positivity to COVID-19 will be enrolled in the study and both conjunctival and nasopharyngeal swab will be performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Cristina Savastano

Roma, 00198, Italy

Location

Related Publications (1)

  • Occhipinti M, Bosello S, Sisti LG, Cicchetti G, de Waure C, Pirronti T, Ferraccioli G, Gremese E, Larici AR. Quantitative and semi-quantitative computed tomography analysis of interstitial lung disease associated with systemic sclerosis: A longitudinal evaluation of pulmonary parenchyma and vessels. PLoS One. 2019 Mar 12;14(3):e0213444. doi: 10.1371/journal.pone.0213444. eCollection 2019.

    PMID: 30861018BACKGROUND

MeSH Terms

Conditions

COVID-19Lung DiseasesDisease

Interventions

RadiationTomography, X-Ray ComputedRadionuclide Imaging

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical PhenomenaImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomographyDiagnostic Techniques, Radioisotope

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

April 22, 2020

First Posted

April 28, 2020

Study Start

March 26, 2020

Primary Completion

April 24, 2020

Study Completion

May 30, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Study Protocol approved by Ethical Committee, informed consent, clinical study report, will be available

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The data will be available immediately after the statistical analysis of the results and will remain available for at least 1 year
Access Criteria
On request by e-mail

Locations

IT(1)