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

November 8, 2022 updated by: GOEHRINGER François, Central Hospital, Nancy, France

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

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Grand Est
      • Vandoeuvre les nancy, Grand Est, France, 54511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms
Time Frame: every 6 months up to 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical history
Time Frame: baseline
baseline
fatigue
Time Frame: every 6 months up to 3 years
Chalder scale: range 0 to 33, >22/33 classified severe
every 6 months up to 3 years
Dyspnea
Time Frame: every 6 months up to 3 years
mMRC
every 6 months up to 3 years
Cognitive impairement
Time Frame: every 6 months up to 3 years
Montréal Cognitive Assessment : range 0 to 30, <26/30 classified pathologic
every 6 months up to 3 years
inappropriate hyperventilation syndrome
Time Frame: every 6 months up to 3 years
Nijmegen score: range 0 to 64, >23/34 classified "possible inapropriate hyperventilation" syndrome"
every 6 months up to 3 years
additional examinations
Time Frame: every 6 months up to 3 years
Biology, imaging
every 6 months up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francois GOEHRINGER, MD, Infectious Diseases Department, Nancy University Hospital,F-54000 Nancy, France.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2022

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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