RNA Sequencing of Individual Versus Wastewater - SARS-CoV2 | NCT05041764

Studies
RNA Sequencing of Individual Versus Wastewater - SARS-CoV2

NCT05041764

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Sep 13, 2021Actual

Enrollment

1,409Actual

Phase

Not provided

Conditions

Infection Viral

Interventions

NO INTERVENTION

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

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Nov 1, 2020Actual

First Submitted Date

Sep 3, 2021

First Submission Date that Met QC Criteria

Sep 3, 2021

First Posted Date

Sep 13, 2021Actual

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

Sep 3, 2021

Last Update Posted Date

Sep 13, 2021Actual

Name	Class
Centre National de la Recherche Scientifique, France	OTHER

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 aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. These values were compared to values measured in wastewater.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,409Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCR positive		samples that are positive for the detection of SARS-CoV2. The SARS-CoV2 sequence of positive samples is provided, together with an indication about patient's neigborhood, corresponding to one of the 21 different spots which wastewater was analyzed	Other: NO INTERVENTION
PCR negative		samples that are p negative for the detection of SARS-CoV2. T	Other: NO INTERVENTION

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NO INTERVENTION	Other	No INTERVENTION	PCR negative PCR positive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RTqPCR result	positive ou negative result to SAR-Cov2	1 month
SARS-CoV2 sequence	analyse of SARS-CoV2 sequence (in the case of positive samples)	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

whole population tested in Nice during W43 of 2020

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

nice population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nice Hospital		Nice		06000	France
Ipmc . Cnrs

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