Cohort of Patients Infected With SARS-CoV2 or Suspected of Being (COVID-19 in Ile-de-France)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,003
- Locations
- 1
- Primary Endpoint
- Identification of prognostic factors for progression to a severe form of COVID-19 infection
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
COVID-19 positive, severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization
Intervention: feces samples (COVI-BIOME ancillary study) (Other)
COVID-19 positive, severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization
Intervention: sweat samples (COVIDOG ancillary study) (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
Intervention: 6 minutes walk test (Other)
COVID-19 positive, severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization
Intervention: Phone call (Other)
COVID-19 positive, not severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization
Intervention: Phone call (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
Intervention: Urine samples (Other)
COVID-19 positive, severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization
Intervention: 6 minutes walk test (Other)
COVID-19 negative
Patients with exclusion diagnosis for COVID-19 infection
Intervention: saliva samples (Other)
COVID-19 negative
Patients with exclusion diagnosis for COVID-19 infection
Intervention: Urine samples (Other)
COVID-19 negative
Patients with exclusion diagnosis for COVID-19 infection
Intervention: blood samples (Other)
COVID-19 negative
Patients with exclusion diagnosis for COVID-19 infection
Intervention: feces samples (COVI-BIOME ancillary study) (Other)
COVID-19 negative
Patients with exclusion diagnosis for COVID-19 infection
Intervention: sweat samples (COVIDOG ancillary study) (Other)
COVID-19 positive, not severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization
Intervention: blood samples (Other)
COVID-19 positive, not severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization
Intervention: feces samples (COVI-BIOME ancillary study) (Other)
COVID-19 positive, not severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization
Intervention: sweat samples (COVIDOG ancillary study) (Other)
COVID-19 positive, not severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization
Intervention: saliva samples (Other)
COVID-19 positive, not severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization
Intervention: Urine samples (Other)
COVID-19 positive, severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization
Intervention: Urine samples (Other)
COVID-19 positive, severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization
Intervention: blood samples (Other)
COVID-19 positive, severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization
Intervention: saliva samples (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
Intervention: blood samples (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
Intervention: saliva samples (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
Intervention: Phone call (Other)
Outcomes
Primary Outcomes
Identification of prognostic factors for progression to a severe form of COVID-19 infection
Time Frame: 12 months
Research of prognostic factors which could be implicated in the progression to severe form of COVID-19 infection.
Secondary Outcomes
- Description of clinical manifestations(12 months)
- Description of physiological manifestations(12 months)
- Clinical aggravation of the infection(12 months)
- Description of radiological manifestations(12 months)
- Patient-related prognostic factors(12 months)
- Discharge of hospitalization(12 months)
- Description of biological manifestations(12 months)
- Virus-related risk factors(12 months)
- Death(12 months)
- Comparison of the results of different diagnosis tests(Up to 12 months)