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

Sponsor
Versailles Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04397666
Collaborator
(none)
68
Enrollment
1
Location
1
Arm
19
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: conjunctival RT PCR
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
RT-PCR on Conjunctival Sample for the Detection of SARS-Cov-2 in Patients With Covid-19
Actual Study Start Date :
May 15, 2020
Actual Primary Completion Date :
Dec 15, 2020
Anticipated Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Diagnostic Test: conjunctival RT PCR
conjunctival sample in covid-19 patients

Outcome Measures

Primary Outcome Measures

  1. the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis [3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de versailles Le Chesnay France 78390

Sponsors and Collaborators

  • Versailles Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edouard KOCH, coordonator investigator, Versailles Hospital
ClinicalTrials.gov Identifier:
NCT04397666
Other Study ID Numbers:
  • P20/09_COVEYES
First Posted:
May 21, 2020
Last Update Posted:
Aug 9, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Aug 9, 2021