Cohort of Patients Infected With SARS-CoV2 (COVID-19) or Suspected of Being
- Conditions
- COVID-19
- Interventions
- Other: blood samplesOther: feces samples (COVI-BIOME ancillary study)Other: sweat samples (COVIDOG ancillary study)Other: saliva samplesOther: Urine samplesOther: 6 minutes walk testOther: Phone call
- Registration Number
- NCT04352348
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2003
- 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
- Refusal of participation
- Patient under justice protection measure except guardianship and trusteeship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COVID-19 positive, severe Phone call Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization COVID-19 negative sweat samples (COVIDOG ancillary study) Patients with exclusion diagnosis for COVID-19 infection COVID-19 positive, severe saliva samples Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization COVID-19 positive, not severe saliva samples Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization COVID-19 negative feces samples (COVI-BIOME ancillary study) Patients with exclusion diagnosis for COVID-19 infection COVID-19 negative saliva samples Patients with exclusion diagnosis for COVID-19 infection COVID-19 negative Urine samples Patients with exclusion diagnosis for COVID-19 infection COVID-19 positive, severe sweat samples (COVIDOG ancillary study) Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization COVID-19 positive, severe 6 minutes walk test Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization Follow-up after COVID-19 hospitalization blood samples 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 COVID-19 positive, not severe sweat samples (COVIDOG ancillary study) Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization COVID-19 positive, not severe blood samples Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization COVID-19 positive, not severe feces samples (COVI-BIOME ancillary study) Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization COVID-19 positive, severe feces samples (COVI-BIOME ancillary study) Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization COVID-19 negative blood samples Patients with exclusion diagnosis for COVID-19 infection COVID-19 positive, not severe Phone call Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization COVID-19 positive, severe Urine samples Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization COVID-19 positive, not severe Urine samples Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization COVID-19 positive, severe blood samples Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization Follow-up after COVID-19 hospitalization saliva samples 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 Follow-up after COVID-19 hospitalization 6 minutes walk test 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 Follow-up after COVID-19 hospitalization Phone call 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 Follow-up after COVID-19 hospitalization Urine samples 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
- Primary Outcome Measures
Name Time Method Identification of prognostic factors for progression to a severe form of COVID-19 infection 12 months Research of prognostic factors which could be implicated in the progression to severe form of COVID-19 infection.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
GH Pitié-Salpêtrière / Service d'Accueil des Urgences
🇫🇷Paris, Ile-de-France, France