NCT04553575

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

September 15, 2020

Last Update Submit

August 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health status in the 2 years after CoViD-19 diagnosis

    status : dead or alive persistante respiratory distress (yes / no)

    2 years follow up

Study Arms (1)

CoViD-19 patients cohort

Patients are followed for 2 years after diagnosis. The only one intervention is blood samples withdrawn for serologies

Biological: serology

Interventions

serologyBIOLOGICAL

biological blood samples withdrawn at 6, 12 and 24 months

CoViD-19 patients cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

  • Patient protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 17, 2020

Study Start

September 25, 2020

Primary Completion

May 24, 2022

Study Completion

August 4, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Locations