Clinical trial NCT04347850: A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19)
Official title: A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19) Infection, From Diagnosis to Long-term Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
COVID-19
Keywords: presence of COVID-19 symptoms
COVID-19 infection
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.

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.


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

* 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

Primary outcomes:
measure: Number of confirmed COVID-19
timeFrame: 1 day
Secondary outcomes:
measure: Number of severe COVID-19
timeFrame: 1 day
measure: Identification and validation of predictive biomarkers of a poorer respiratory evolution associated with positive testing for SARS-CoV-2 infection
timeFrame: 1 day
measure: Evaluate the morbidity and mortality and these risk factors linked to Covid-19 in the congenital heart disease population in France
timeFrame: 1 day
measure: Identify the characteristics of physiotherapy care for patients with COVID-19 in intensive care
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: Evaluate diagnostic tests for olfactory function in relation to the RT-PCR procedure
timeFrame: 1 day
measure: Assessment of Extra Vascular Lung Water and Pulmonary Permeability by transpulmonary thermodilution in critically ill patients with Coronavirus Disease 2019 pneumonia under invasive mechanical ventilation
timeFrame: 1 day
measure: Description of trans pulmonary motor pressure in COVID 19+ patients in severe stage in intensive care
timeFrame: 1 day
measure: Immuno-monitoring of COVID-19 positive patients
timeFrame: 1 day
measure: Characterization in clinical proteomics of the SARS-CoV-2 spike protein
timeFrame: 1 day
measure: Diagnosis of endocrine dysfunctions in Covid-19
timeFrame: 1 day
measure: describe the occurrence of Covid19 infection in patients with systemic lupus erythematosus treated with hydroxychloroquine over the long term
timeFrame: 1 day
measure: Acral cutaneous thrombotic vasculopathy and Covid-19 infection : search for acquired thrombophilia and interferon-alpha signature
timeFrame: 1 day
measure: Evaluation of a COVID-19 screening strategy combining chest low dose CT and RT-PCR test for patients admitted for surgical or interventional procedures during the COVID 19 outbreak
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Edouard TUAILLON, MD; PhD
role: STUDY_DIRECTOR
References: