- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05610436
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
Status
Recruiting
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
- Name: Francois GOEHRINGER, MD
- Phone Number: +33383154097
- Email: francois.goehringer@chru-nancy.fr
Study Locations
-
-
Grand Est
-
Vandoeuvre les nancy, Grand Est, France, 54511
- Recruiting
- Nancy University Hospital
-
Contact:
- Francois GOEHRINGER, MD
- Phone Number: +33383154097
- Email: francois.goehringer@chru-nancy.fr
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022PI148
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.