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CoViD-19 Patient in Reims University Hospital in March to April 2020 (COVID-Reims)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553575
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Tracking Information
First Submitted Date September 15, 2020
First Posted Date September 17, 2020
Last Update Posted Date October 5, 2020
Actual Study Start Date September 25, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2020)
Health status in the 2 years after CoViD-19 diagnosis [ Time Frame: 2 years follow up ]
status : dead or alive persistante respiratory distress (yes / no)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CoViD-19 Patient in Reims University Hospital in March to April 2020
Official Title Follow-up CoViD-19 Patients Hospitalized in Reims University Hospital Between the 01/03/2020 and 30/04/2020
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
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples Without DNA
Description:
blood samples
Sampling Method Non-Probability Sample
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
Condition Coronavirus Infections
Intervention Biological: serology
biological blood samples withdrawn at 6, 12 and 24 months
Study Groups/Cohorts CoViD-19 patients cohort
Patients are followed for 2 years after diagnosis. The only one intervention is blood samples withdrawn for serologies
Intervention: Biological: serology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 16, 2020)
499
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Damien Jolly 03 26 78 84 72 ext 0033 djolly@chu-reims.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04553575
Other Study ID Numbers PO20124*
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party CHU de Reims
Study Sponsor CHU de Reims
Collaborators Not Provided
Investigators Not Provided
PRS Account CHU de Reims
Verification Date October 2020