RT-PCR on Conjunctival Sample for the Detection of SARS-C... | NCT04397666

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

NCT04397666

Sponsor

Versailles Hospital

Status

Unknown status

Last Update Posted

Aug 9, 2021Actual

Enrollment

68Actual

Phase

Not Applicable

Conditions

SARS-CoV Infection
Pinkeye

Interventions

conjunctival RT PCR

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Dec 15, 2020Actual

Completion Date

Dec 15, 2021Estimated

First Submitted Date

May 20, 2020

First Submission Date that Met QC Criteria

May 20, 2020

First Posted Date

May 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2021

Last Update Posted Date

Aug 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Diagnostic Test: conjunctival RT PCR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
conjunctival RT PCR	Diagnostic Test	conjunctival sample in covid-19 patients	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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:
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de versailles		Le Chesnay		78390	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D045169	Severe Acute Respiratory Syndrome
D003231	Conjunctivitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D018352	Coronavirus Infections
D003333	Coronaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided