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RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19 (P20/09)

Primary Purpose

SARS-CoV Infection, Pinkeye

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
conjunctival RT PCR
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SARS-CoV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. EN > or =30/min,
    2. Pao2/Fio2 = or < 300,
    3. confusion and/or disorientation,
    4. hypotension (Tas90mmhg, requiring aggressive filling),
    5. need for a invasive ventilation,
    6. septic shock

Sites / Locations

  • Centre Hospitalier de versailles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 20, 2020
Last Updated
August 6, 2021
Sponsor
Versailles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04397666
Brief Title
RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19
Acronym
P20/09
Official Title
RT-PCR on Conjunctival Sample for the Detection of SARS-Cov-2 in Patients With Covid-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, Pinkeye

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
conjunctival RT PCR
Intervention Description
conjunctival sample in covid-19 patients
Primary Outcome Measure Information:
Title
the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis
Description
to assess the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Centre Hospitalier de versailles
City
Le Chesnay
ZIP/Postal Code
78390
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19

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