NCT04347850

Brief Summary

SARV-CoV-2 infection was considered pandemic on March 11, 2020. The SARV-CoV-2 epidemic affected France from the beginning of March, spreading in particular from a 4-day large evangelical meeting of 2500 people on February 17 in the city of Mulhouse (North East of France). The Montpellier University Hospital has set up a clinical pathway for people suspected of being infected with SARV-CoV-2 because of signs compatible with pneumonia (screening criteria in France during the study period). This includes an emergency department, an infectious disease department dedicated to the surveillance of infected people requiring hospital treatment, and an intensive care unit for the most severe cases. The diagnosis of infection with SARV-CoV-2 was confirmed in approximately 20% of people initially referred in this special care system. The main objective of this cohorte is the collection of clinical data and biological samples from care for non-interventional research on the patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

2.8 years

First QC Date

April 9, 2020

Last Update Submit

July 6, 2020

Conditions

SARS-CoV-2COVID-19

Keywords

presence of COVID-19 symptomsCOVID-19 infection

Outcome Measures

Primary Outcomes (1)

  • Number of confirmed COVID-19

    Number of confirmed COVID-19

    1 day

Secondary Outcomes (14)

  • Number of severe COVID-19

    1 day

  • Identification and validation of predictive biomarkers of a poorer respiratory evolution associated with positive testing for SARS-CoV-2 infection

    1 day

  • Evaluate the morbidity and mortality and these risk factors linked to Covid-19 in the congenital heart disease population in France

    1 day

  • Identify the characteristics of physiotherapy care for patients with COVID-19 in intensive care

    1 day

  • To assess the accuracy and prognostic performance of clinical and biological parameters measured on admission to the emergency department to stratify patients suspected of COVID-19

    1 day

  • +9 more secondary outcomes

Study Arms (3)

Patient with Covid-19 confirmed (middle form)

Covid-19 confirmed: middle form

Other: blood sample

Patient with Covid-19 confirmed (severe form)

Covid-19 confirmed : severe form

Other: blood sample

Patient with Covid-19 not confirmed

Covid-19 not confirmed

Other: blood sample

Interventions

blood sampleOTHER

Collection

Patient with Covid-19 confirmed (middle form)Patient with Covid-19 confirmed (severe form)Patient with Covid-19 not confirmed

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.

You may qualify if:

  • \- Patients care at the Montpellier University Hospital suspected of a COVID-19 infection

You may not qualify if:

  • Patient opposed to the use of his data for research purposes
  • Patient deprived of liberty by judicial decision
  • Patient not affiliated to a social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34280, France

RECRUITING

Related Publications (1)

  • Capelli N, Domitien Payet L, Alcocer Cordellat C, Pisoni A, Engelmann I, Van de Perre P, Jeziorski E, Tuaillon E. SARS-CoV-2 nucleocapsid antigen in plasma of children hospitalized for COVID-19 or with incidental detection of SARS-CoV-2 infection. J Med Virol. 2024 Jan;96(1):e29358. doi: 10.1002/jmv.29358.

    PMID: 38180230DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, total blood, urine, stool, oral fluid

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Edouard TUAILLON, MD; PhD

    UH MONTPELLIER

    STUDY DIRECTOR

Central Study Contacts

Edouard TUAILLON, MD; PhD

CONTACT

467 338 469e-tuaillon@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 15, 2020

Study Start

February 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 30, 2022

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

NC

Locations

FR(1)