NCT04363385

Brief Summary

Biological collection (blood sample) associated with clinical data from Covid-19 patients

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
terminated

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

April 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

3 years

First QC Date

April 21, 2020

Last Update Submit

April 11, 2024

Conditions

Covid-19

Keywords

Blood samplesADNARNplasma

Outcome Measures

Primary Outcomes (1)

  • Phenotype/genotype correlation research modulating the severity of Covid-19 disease

    Clinical aggravation markers (admission in intensive care)

    Anytime in the period of 10 years

Secondary Outcomes (8)

  • Phenotype/transcriptomic correlation research modulating the severity of Covid-19 disease

    Anytime in the period of 10 years

  • Phenotype/biomarker correlation research modulating the severity of Covid-19 disease

    Anytime in the period of 10 years

  • Development of clinical-biological scores in the severity of Covid-19 disease

    Anytime in the period of 10 years

  • Development of predictive imaging scores in the severity of Covid-19 disease

    Anytime in the period of 10 years

  • Identification of pathophysiological pathways to susceptibility to Covid-19 disease

    Anytime in the period of 10 years

  • +3 more secondary outcomes

Study Arms (1)

Collection of blood sample

OTHER
Biological: Biological test

Interventions

Biological testBIOLOGICAL

Blood sample

Collection of blood sample

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of COVID-19 confirmed on RT-PCR test or chest scanner
  • Any age
  • Membership in the general social security system
  • Inform consent signed by the patient or by legal representatives for minors

You may not qualify if:

  • Refusal of the patient or one of the legal representatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier intercommunal de Créteil

Créteil, 94010, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Collection of blood samples in a cohort of Covid-19 patients
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 27, 2020

Study Start

May 31, 2020

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)