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

COVID-19 Clinical Trial

— COVIDeF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04352348
• Other study ID #: APHP200382
• Secondary ID: 2020-A00754-35
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2003
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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
• 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
• sweat samples (COVIDOG ancillary study)
All arms: 2 sweat samples at inclusion (T0)
• 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
• 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.
• 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.
• 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

Locations

Country	Name	City	State
France	GH Pitié-Salpêtrière / Service d'Accueil des Urgences	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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