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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: SARS-CoV Infection; Pinkeye
• Intervention / Treatment: Diagnostic test: conjunctival RT PCR

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78390
    • Centre Hospitalier De Versailles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Diagnostic test: conjunctival RT PCR; conjunctival sample in covid-19 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Versailles Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2020
• Primary Completion (ACTUAL): December 15, 2020
• Study Completion (ANTICIPATED): December 15, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (ACTUAL): May 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: P20/09_COVEYES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No