CoViD-19 Patient in Reims University Hospital in March to... | NCT04553575

Studies
CoViD-19 Patient in Reims University Hospital in March to April 2020

NCT04553575

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

Aug 8, 2022Actual

Enrollment

127Actual

Phase

Not provided

Conditions

Coronavirus Infections

Interventions

serology

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 2022

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

Sep 25, 2020Actual

Primary Completion Date

May 24, 2022Actual

Completion Date

Aug 4, 2022Actual

First Submitted Date

Sep 15, 2020

First Submission Date that Met QC Criteria

Sep 16, 2020

First Posted Date

Sep 17, 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 5, 2022

Last Update Posted Date

Aug 8, 2022Actual

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

Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up.

Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research)

Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients.

Material and methods:

Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022

Expected results: Better knowledge of the cares of patients with CoViD-19

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

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

127Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CoViD-19 patients cohort		Patients are followed for 2 years after diagnosis. The only one intervention is blood samples withdrawn for serologies	Biological: serology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serology	Biological	biological blood samples withdrawn at 6, 12 and 24 months	CoViD-19 patients cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health status in the 2 years after CoViD-19 diagnosis	status : dead or alive persistante respiratory distress (yes / no)	2 years follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay service of Reims University Hospital and included in Covid-19 Cohort
Age > 18 years
Patient who benefit from the national health insurance coverage
patient agree for participation (consent form signed)

Exclusion Criteria:

Patient protected by law

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

Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay service of Reims University Hospital and included in Covid-19 Cohort

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Chu Reims		Reims		51092	France

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided