Analysing the French COVID-19 Epidemic Using a National S... | NCT04738331

Studies
Analysing the French COVID-19 Epidemic Using a National SARS-CoV-2 RT-PCR Database

NCT04738331

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

May 26, 2021Actual

Enrollment

10,000,000Estimated

Phase

Not provided

Conditions

Covid-19
SARS-CoV Infection

Interventions

Not provided

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

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

May 20, 2022Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Feb 2, 2021

First Submission Date that Met QC Criteria

Feb 2, 2021

First Posted Date

Feb 4, 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

May 25, 2021

Last Update Posted Date

May 26, 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

Analysing ths spread of COVID-19 epidemics in a timely manner is key to implementing public health control strategies. The investigators propose to analyse a large set of laboratory SARS-CoV-2 RT-PCR data to explore potential links between Ct values and epidemic parameters.

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

10,000,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detecting co-factors associated with Ct values	Detecting co-factors associated with Ct values	1 day

Secondary Outcomes

Measure	Description	Time Frame
Detecting associations with epidemic spread	Detecting associations with epidemic spread	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- A SARS-Cov2 RT-PCR result with a known sampling date

Exclusion criteria:

- Patient refusing to participate in research

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

French population with a RT-PCR test for SARS-Cov2 infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samuel Alizon, PhD	Contact	610654902	33	samuel.alizon@cnrs.fr
Vincent Foulongne, PhD	Contact	467 330 254	33	v-foulongne@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Vincent Foulongne, PhD	UH MONTPELLIER	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D045169	Severe Acute Respiratory Syndrome

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided