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

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19; SARS-CoV-2
• Intervention / Treatment: Other: blood sample

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34280
    • Recruiting
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with Covid-19 confirmed (middle form); Covid-19 confirmed: middle form	Other: blood sample; Collection
Patient with Covid-19 confirmed (severe form); Covid-19 confirmed : severe form	Other: blood sample; Collection
Patient with Covid-19 not confirmed; Covid-19 not confirmed	Other: blood sample; Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of confirmed COVID-19	Number of confirmed COVID-19	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of severe COVID-19	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	CORO-TRI substudy	1 day
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
Identify the characteristics of physiotherapy care for patients with COVID-19 in intensive care	Physio-Covid substudy	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	Covida substudy	1 day
Evaluate diagnostic tests for olfactory function in relation to the RT-PCR procedure	Olfa-covid substudy	1 day
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
Description of trans pulmonary motor pressure in COVID 19+ patients in severe stage in intensive care	TRANSPULMONARY-COVID19 substudy	1 day
Immuno-monitoring of COVID-19 positive patients	CytoCOVID substudy	1 day
Characterization in clinical proteomics of the SARS-CoV-2 spike protein	ProteoCOVID substudy	1 day
Diagnosis of endocrine dysfunctions in Covid-19	Dyhor-19 substudy	1 day
describe the occurrence of Covid19 infection in patients with systemic lupus erythematosus treated with hydroxychloroquine over the long term	Lupus substudy	1 day
Acral cutaneous thrombotic vasculopathy and Covid-19 infection : search for acquired thrombophilia and interferon-alpha signature	Vasculopathy substudy	1 day
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Edouard TUAILLON, MD; PhD, UH Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19 infection; presence of COVID-19 symptoms
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RECHMPL20_0185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No