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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

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


Condition or disease Intervention/treatment
Coronavirus Infections Biological: serology

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 499 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Follow-up CoViD-19 Patients Hospitalized in Reims University Hospital Between the 01/03/2020 and 30/04/2020
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CoViD-19 patients cohort
Patients are followed for 2 years after diagnosis. The only one intervention is blood samples withdrawn for serologies
Biological: serology
biological blood samples withdrawn at 6, 12 and 24 months




Primary Outcome Measures :
  1. 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)


Biospecimen Retention:   Samples Without DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553575


Contacts
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Contact: Damien Jolly 03 26 78 84 72 ext 0033 djolly@chu-reims.fr

Locations
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France
Chu Reims Recruiting
Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT04553575    
Other Study ID Numbers: PO20124*
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases