Cohort of Patients Infected With SARS-CoV2 (COVID-19) or Suspected of Being (COVIDeF)

Cohort of Patients Infected With SARS-CoV2 or Suspected of Being (COVID-19 in Ile-de-France)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: blood samples; Other: feces samples (COVI-BIOME ancillary study); Other: sweat samples (COVIDOG ancillary study); Other: saliva samples; Other: Urine samples; Other: Phone call; Other: 6 minutes walk test

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.

• Study Type: Interventional
• Enrollment (Actual): 2003
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75013
      • GH Pitié-Salpêtrière / Service d'Accueil des Urgences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: COVID-19 negative; Patients with exclusion diagnosis for COVID-19 infection	Other: blood samples; All arms: 1 blood sample at inclusion (T0) COVID-19 positive, severe only: 1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: feces samples (COVI-BIOME ancillary study); All arms: 1 feces sample at inclusion (T0) COVID-19 positive, severe only: 1 feces sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms and, eventually, at discharge from hospital; Other: sweat samples (COVIDOG ancillary study); All arms: 2 sweat samples at inclusion (T0); Other: saliva samples; All arms: 1 saliva sample at inclusion (T0) COVID-19 positive, severe only: 1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: Urine samples; All arms: 1 urine sample at inclusion (T0) COVID-19 positive, severe only: 1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization
OTHER: COVID-19 positive, not severe; Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization	Other: blood samples; All arms: 1 blood sample at inclusion (T0) COVID-19 positive, severe only: 1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: feces samples (COVI-BIOME ancillary study); All arms: 1 feces sample at inclusion (T0) COVID-19 positive, severe only: 1 feces sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms and, eventually, at discharge from hospital; Other: sweat samples (COVIDOG ancillary study); All arms: 2 sweat samples at inclusion (T0); Other: saliva samples; All arms: 1 saliva sample at inclusion (T0) COVID-19 positive, severe only: 1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: Urine samples; All arms: 1 urine sample at inclusion (T0) COVID-19 positive, severe only: 1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: Phone call; All arms except COVID-19 negative: 1 phone call 3 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 6 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 12 months after COVID-19 infection.
OTHER: COVID-19 positive, severe; Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization	Other: blood samples; All arms: 1 blood sample at inclusion (T0) COVID-19 positive, severe only: 1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: feces samples (COVI-BIOME ancillary study); All arms: 1 feces sample at inclusion (T0) COVID-19 positive, severe only: 1 feces sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms and, eventually, at discharge from hospital; Other: sweat samples (COVIDOG ancillary study); All arms: 2 sweat samples at inclusion (T0); Other: saliva samples; All arms: 1 saliva sample at inclusion (T0) COVID-19 positive, severe only: 1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: Urine samples; All arms: 1 urine sample at inclusion (T0) COVID-19 positive, severe only: 1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: Phone call; All arms except COVID-19 negative: 1 phone call 3 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 6 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 12 months after COVID-19 infection.; Other: 6 minutes walk test; COVID-19 positive, severe only: 6 minutes walk test in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 6 minutes walk test at inclusion (T0) and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
OTHER: Follow-up after COVID-19 hospitalization; Patients previously hospitalized for COVID-19 infection but not recruited for the study can be recruited during a follow-up visit in hospital scheduled in standard care at 3 to 6 months after the hospitalization. For this arm, T0 = 3 to 6 months post-COVID-19 follow-up visit	Other: blood samples; All arms: 1 blood sample at inclusion (T0) COVID-19 positive, severe only: 1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: saliva samples; All arms: 1 saliva sample at inclusion (T0) COVID-19 positive, severe only: 1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: Urine samples; All arms: 1 urine sample at inclusion (T0) COVID-19 positive, severe only: 1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization; Other: Phone call; All arms except COVID-19 negative: 1 phone call 3 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 6 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 12 months after COVID-19 infection.; Other: 6 minutes walk test; COVID-19 positive, severe only: 6 minutes walk test in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 6 minutes walk test at inclusion (T0) and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of prognostic factors for progression to a severe form of COVID-19 infection	Research of prognostic factors which could be implicated in the progression to severe form of COVID-19 infection.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Death	12 months
Clinical aggravation of the infection	12 months
Discharge of hospitalization	12 months
Description of clinical manifestations	12 months
Description of biological manifestations	12 months
Description of radiological manifestations	12 months
Description of physiological manifestations	12 months
Patient-related prognostic factors	12 months
Virus-related risk factors	12 months
Comparison of the results of different diagnosis tests	Up to 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Pierre HAUSFATER, MD, GH Pitié Salpêtrière - Charles Foix

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2020
• Primary Completion (ANTICIPATED): May 31, 2022
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; cohort; prognostic factors; severe forms
• 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: APHP200382; 2020-A00754-35 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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