NCT04397666

Brief Summary

the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients

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
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 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

May 15, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

May 20, 2020

Last Update Submit

August 6, 2021

Conditions

SARS-CoV InfectionPinkeye

Outcome Measures

Primary Outcomes (1)

  • the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis

    to assess the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis

    3 months

Study Arms (1)

1

EXPERIMENTAL
Diagnostic Test: conjunctival RT PCR

Interventions

conjunctival RT PCRDIAGNOSTIC_TEST

conjunctival sample in covid-19 patients

1

Eligibility Criteria

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

You may qualify if:

  • Men and Women positive for SARS-Cov-2 on a RT-PCR test of a sample of respiratory airway
  • Persons over 18 years of age
  • patients of both sexes
  • Member of a social security scheme
  • Having signed the consent form

You may not qualify if:

  • Minors not emancipated, persons out of state to express their consent
  • Participation in intervention research on Covid-19 involving experimental treatment
  • History of chronic disease conjunctiva
  • Patient with one of the one of the criteria of following gravity:
  • EN \> or =30/min,
  • Pao2/Fio2 = or \< 300,
  • confusion and/or disorientation,
  • hypotension (Tas90mmhg, requiring aggressive filling),
  • need for a invasive ventilation,
  • septic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de versailles

Le Chesnay, 78390, France

Location

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeConjunctivitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesConjunctival DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
coordonator investigator

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 21, 2020

Study Start

May 15, 2020

Primary Completion

December 15, 2020

Study Completion

December 15, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations

FR(1)