Clinical trial NCT04352348: Cohort of Patients Infected With SARS-CoV2 (COVID-19) or Suspected of Being
Official title: Cohort of Patients Infected With SARS-CoV2 or Suspected of Being (COVID-19 in Ile-de-France)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
cohort
prognostic factors
severe forms
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 2003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: On 17th March 2020, 198 193 confirmed cases (7 730 in France) of COVID-19 infections and 7 854 deaths (175 in France) have been reported from 8th December 2019 in 157 countries. The rapid increase in cases on french territory has led to the transition of France to level 3 of the epidemic on 14th March 2020.

The natural history of the disease is still poorly understood, especially prognostic factors, which are crucial for the best medical care of patients in times of epidemics, when hospital capacities are under pressure.

A better knowledge of natural history, of prognostic factors, the development and validation of new diagnostic tests, the evaluation of medical care, will lead to a better medical care of patients infected with COVID-19.

Detailed description: The principal goal of the research is to assess the prognostic factors of the progression toward severe forms of the COVID-19 infection.

The secondary aims of the study are to contribute to answer some of the WHO research priority goals on COVID-19 infections:

* description of the natural history of the disease, its different forms, its clinical characterisation, its progression profile, the natural history of the disease linked to patient profiles
* evaluation and to comparison of different diagnostic methods, linked to the medical case
* description of the progression of the immune response during the infection and related to its outcome
* description of the replication and the excretion of the virus
* description of the progression of the biological markers during the infection and related to its outcome
* identification of the prognostic factors of the evolutive profile, especially if negative
* description of the patients care
* evaluation of the impact of the different therapeutic managements on the clinical outcome, the immune response, the viral load and the biomarkers.
* modeling of the epidemiologic impact
* identification of targets for treatment development
* analysis of cost data linked to the progression The population will include all patients infected with SARS-CoV2 ou suspected of being, who are taken care of at hospital.

The research is based on the collection of clinical and biological data from routine cares and on the biological analysis of blood samples.

The principal goal of the COVI-BIOME ancillary study is to identify gastrointestinal predictive factors for a severe form of the COVID-19 infection.

The principal goal of the COVIDOG ancillary study is to evaluate the sensibility and the specificity of canine olfactory detection for the volatile organic compounds of SARS-CoV2.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Patient admitted in an emergency unit or hospitalized, infected with SARS-CoV2 or suspected of being (the recruitment can occured during acute episode or during a follow-up visit)
* Written informed consent or emergency procedure
* Affiliated to health insurance system

Exclusion Criteria:

* Refusal of participation
* Patient under justice protection measure except guardianship and trusteeship

Primary outcomes:
measure: Identification of prognostic factors for progression to a severe form of COVID-19 infection
timeFrame: 12 months
Secondary outcomes:
measure: Clinical aggravation of the infection
timeFrame: 12 months
measure: Discharge of hospitalization
timeFrame: 12 months
measure: Death
timeFrame: 12 months
measure: Description of clinical manifestations
timeFrame: 12 months
measure: Description of biological manifestations
timeFrame: 12 months
measure: Description of radiological manifestations
timeFrame: 12 months
measure: Description of physiological manifestations
timeFrame: 12 months
measure: Patient-related prognostic factors
timeFrame: 12 months
measure: Virus-related risk factors
timeFrame: 12 months
measure: Comparison of the results of different diagnosis tests
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: GH Pitié-Salpêtrière / Service d'Accueil des Urgences
state: Ile-de-France
Study officials:
affiliation: GH Pitié Salpêtrière - Charles Foix
name: Pierre HAUSFATER, MD
role: PRINCIPAL_INVESTIGATOR
References: