Post-Covid Condition Cohort: Evolution of Symptomatology,... | NCT05610436

Studies
Post-Covid Condition Cohort: Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors

NCT05610436

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Nov 9, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Long COVID
Post-Acute COVID-19
Post-Acute COVID19 Syndrome

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

Oct 2022

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

Jan 7, 2022Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Oct 20, 2022

First Submission Date that Met QC Criteria

Nov 8, 2022

First Posted Date

Nov 9, 2022Actual

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

Nov 8, 2022

Last Update Posted Date

Nov 9, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

GOEHRINGER François, Principal Investigator, clinical physician, Infectious Diseases department, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

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 of our cohort is to collect prospectively, in a standardized and exhaustive manner, the health data of patients referred to the CAPCoV, our holistic referal post covid clinics for post-covid condition in order to be able to identify typical profiles of patients suffering from post covid syndrome and to follow the evolution of their disease over time.

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

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptoms	Symptoms collected in a standardized manner during consultations, their persistence over time, their evolution (improvement, stagnation, worsening) and their severity (mild, moderate, severe)	every 6 months up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Medical history		baseline
fatigue	Chalder scale: range 0 to 33, >22/33 classified severe	every 6 months up to 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

outpatients treated in the Nancy University Hospital Long Covid Support and Care Center for post-Covid condition according to WHO definition

Exclusion Criteria:

patient opposing the processing for research purposes of their data collected in routine care for their care

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

outpatients treated in the Nancy University Hospital Long Covid Support and Care Center for post-Covid condition according to WHO definition

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francois GOEHRINGER, MD	Contact	+33383154097		francois.goehringer@chru-nancy.fr

Overall Officials

Name	Affiliation	Role
Francois GOEHRINGER, MD	Infectious Diseases Department, Nancy University Hospital,F-54000 Nancy, France.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nancy University Hospital	Recruiting	Vandœuvre-lès-Nancy	Grand Est	54511	France

Condition Browse Module

MeSH Terms

ID	Term
D000094024	Post-Acute COVID-19 Syndrome

Ancestor Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided