A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19)

COVID-19 Clinical Trial

— COVIDothèque  

Official title:

A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19) Infection, From Diagnosis to Long-term Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347850
• Other study ID #: RECHMPL20_0185
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2020
• Source: University Hospital, Montpellier
• Contact: Edouard TUAILLON, MD; PhD
• Phone: 467 338 469
• Email: e-tuaillon[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Other:
• blood sample
Collection

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of confirmed COVID-19	Number of confirmed COVID-19	1 day
Secondary	Number of severe COVID-19	Number of severe COVID-19	1 day
Secondary	Identification and validation of predictive biomarkers of a poorer respiratory evolution associated with positive testing for SARS-CoV-2 infection	CORO-TRI substudy	1 day
Secondary	Evaluate the morbidity and mortality and these risk factors linked to Covid-19 in the congenital heart disease population in France	COVID-CHD substudy	1 day
Secondary	Identify the characteristics of physiotherapy care for patients with COVID-19 in intensive care	Physio-Covid substudy	1 day
Secondary	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	Covida substudy	1 day
Secondary	Evaluate diagnostic tests for olfactory function in relation to the RT-PCR procedure	Olfa-covid substudy	1 day
Secondary	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	PiCCOVID substudy	1 day
Secondary	Description of trans pulmonary motor pressure in COVID 19+ patients in severe stage in intensive care	TRANSPULMONARY-COVID19 substudy	1 day
Secondary	Immuno-monitoring of COVID-19 positive patients	CytoCOVID substudy	1 day
Secondary	Characterization in clinical proteomics of the SARS-CoV-2 spike protein	ProteoCOVID substudy	1 day
Secondary	Diagnosis of endocrine dysfunctions in Covid-19	Dyhor-19 substudy	1 day
Secondary	describe the occurrence of Covid19 infection in patients with systemic lupus erythematosus treated with hydroxychloroquine over the long term	Lupus substudy	1 day
Secondary	Acral cutaneous thrombotic vasculopathy and Covid-19 infection : search for acquired thrombophilia and interferon-alpha signature	Vasculopathy substudy	1 day
Secondary	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	COVID-Scan study	1 day