Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF

NCT04344327 | Completed

• 1 other identifier: 2020-02
• Study Type: observational
• Target: 2,878
• Locations: 1 country
• Sites: 23

Brief Summary

The COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.

Conditions

Infection Viral; Infection, Hospital; COVID

Keywords

Cardiology department; Medicine conventional department

Outcome Measures

Primary Outcomes (3)

• Death rate

  Analysis of all-cause death in relation with clinical patient profile

  Through study completion, an average of 4 weeks

• Transfer to intensive care unit

  Correlation between clinical patient profile and transfer need to intensive care unit

  Through study completion, an average of 4 weeks

• Ventilation analysis

  Type of ventilation procedures needed during the hospitalization (Orotracheal intubation for mechanical ventilation or Non-invasive ventilation or 29/5000 high flow oxygen therapy - Optiflow) in relation with clinical patient profile

  Through study completion, an average of 4 weeks

Secondary Outcomes (1)

• Construction of a predictive score for COVID-19 severe form

  Through study completion, an average of 4 weeks

Study Arms (1)

Patients with COVID-19

Patients hospitalized in conventional sector with diagnosis of COVID-19 (positive PCR (Polymerase Chain Reaction) or diagnosis presumed by the clinical and radiographic picture)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to the hospital with COVID-19 infection

You may qualify if:

• \- Patients hospitalized in cardiology unit or medicine conventional sector with diagnosis of COVID-19 (positive PCR (Polymerase Chain Reaction) or diagnosis presumed by the clinical and radiographic picture)

You may not qualify if:

• Minors
• Pregnant women

Sponsors & Collaborators

• French Cardiology Society: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (23)

CHU d'Amiens

Amiens, 80054, France

Location

CHU Annecy

Annecy, 74374, France

Location

CHU de Bordeaux

Bordeaux, 33404, France

Location

CHU de Caen

Caen, 14033, France

Location

Cotentin hospital

Cherbourg, 50100, France

Location

CHU Dijon

Dijon, 21079, France

Location

Elbeuf Louviers Val de Reuil

Elbeuf, 76500, France

Location

CHU de Fréjus / Saint-Raphael

Fréjus, 83608, France

Location

Lille Catholic Institute Hospital Group, Lille

Lille, 59000, France

Location

CHU de Lyon

Lyon, 69229, France

Location

APHM

Marseille, 13000, France

Location

Jacques Cartier Private Hospital, Massy

Massy, 91300, France

Location

CHR d'Orléans

Orléans, France

Location

Bichat (APHP)

Paris, 75000, France

Location

Georges Pompidou European Hospital (AP-HP)

Paris, 75000, France

Location

Institut Mutualiste Montsouris, Paris

Paris, 75000, France

Location

CHU de Reims

Reims, 51092, France

Location

CHU de Rouen

Rouen, 76000, France

Location

CHU Saint Etienne

Saint-Etienne, 42055, France

Location

CHU de Strasbourg

Strasbourg, 67000, France

Location

CHU de Toulouse

Toulouse, 31000, France

Location

Saint Gatien hospital

Tours, 3540, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• Sutter W, Duceau B, Vignac M, Bonnet G, Carlier A, Roussel R, Trimaille A, Pommier T, Guilleminot P, Sagnard A, Pastier J, Weizman O, Giordano G, Cellier J, Geneste L, Panagides V, Marsou W, Deney A, Karsenty C, Attou S, Delmotte T, Ribeyrolles S, Chemaly P, Gautier A, Fauvel C, Chaumont C, Mika D, Pezel T, Cohen A, Potier L; Critical COVID-19 France Investigators. Association of diabetes and outcomes in patients with COVID-19: Propensity score-matched analyses from a French retrospective cohort. Diabetes Metab. 2021 Jul;47(4):101222. doi: 10.1016/j.diabet.2020.101222. Epub 2020 Dec 31.

  PMID: 33388386 DERIVED

MeSH Terms

Conditions

Virus Diseases; Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillaume BONNET, MD

  Hopital Européen Georges Pompidou

  STUDY DIRECTOR

• Orianne WEIZMAN, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: April 10, 2020
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (23)